Rehabilitation aimed at improving outdoor mobility for people after stroke: a multi-centre randomised controlled study (the Getting out of the House Study)

Article history

The research reported in this issue of the journal was funded by the HTA programme as project number 08/14/51. The contractual start date was in August 2009. The draft report began editorial review in December 2012 and was accepted for publication in June 2013. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report.

Declared competing interests of authors

Professor Marion Walker is a member of the Global Stroke Community Advisory Panel (GSCAP), funded by Allergan. Hywel Williams is a member of the NIHR Journals Library Board.

Copyright statement

© Queen’s Printer and Controller of HMSO 2014. This work was produced by Logan et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

Introduction

In 2009 the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme funded a proposal to investigate the clinical effectiveness and cost-effectiveness of delivering a targeted outdoor mobility therapy provided within stroke services aimed at helping people get out of the house more often following a stroke. This report details the results of the Getting out of the House Study.

The effect of stroke on functioning, and rehabilitation

Stroke can have a devastating effect on people’s lives, with half of survivors being dependent on others 6 months later,1 one-third feeling socially isolated, one-quarter having abnormal moods, and half not getting out of their houses as much as they would like. 2 These are worldwide health-care issues but, with 130,000 people a year having a stroke in England and Wales,3 and stroke increasing with age, the number of people needing UK health and social care services is set to rise. The cost of stroke to the UK NHS is estimated to be over £2.5B per year3 in addition to the cost to social care services and to the stroke survivors. In the UK most people who have a stroke are admitted to hospital for acute care but are discharged on average 19.5 days later. 4 Treatment is then transferred to community-based teams and social care services.

Stroke unit care has been found to be the best way to organise inpatient care for stroke patients,5 allowing them to be transferred to evidenced-based Early Supported Stroke Discharge services6 when they go home. Once home, stroke rehabilitation interventions provided by occupational therapists have been shown to increase activity7 ^, 8 by helping people to regain independence in personal and domestic activities of daily living. Most stroke rehabilitation research has been conducted on people in the first year after their stroke. Although many consequences of stroke persist beyond a year there is little evidence for the benefit of interventions delivered after 1 year. 9 The early treatment and rehabilitation of stroke necessarily focuses on reducing neurological impairments but as time goes by after a stroke the activity and participation become more important. Also, the first goal of patients in hospital tends to be to get home, which requires a focus on self-care activities, but, once home, they set goals in terms of being able to optimise participation, and these tend to require an ability to get out of the house or to engage in social activities. However, these rehabilitation areas are rarely targeted.

Outdoor mobility after a stroke, and rehabilitation

Stroke can leave people with long-term and persistent impairments, leading to activity limitations and restriction in participation. These restrictions occur in addition to other impairments resulting from comorbidities, such as osteoarthritis or dementia, making recovery and evaluation of treatments difficult and complicated. In addition, stroke often leaves people with perceptual and cognitive impairments that can reduce performance of everyday activities, such as shopping, hobbies, cooking or using the bus. Lowering of mood, feelings of becoming a different person and lack of confidence are also common after stroke. 10 These hidden impairments often go untreated and, alongside the more obvious physical ones, contribute to activity limitations especially when people are discharged from health services. There is evidence that stroke patients may delay getting back to a normal life, even although they may have made a good physical recovery. 11 Hellstrom et al. 12 argued it is not until people go home after a stroke and attempt to try everyday activities that the real impact is realised. 12 In response to this, it is recommended that all stroke patients receive a 6-month review, with rehabilitation being available to enable people to maintain participation, reduce long-term misery and improve quality of life. These are priority areas identified in the Department of Health of England and Wales Stroke Strategy. 13

Limitations in outdoor mobility affect 42% of stroke patients,2 with 33% remaining permanently dependent on others long term. 3 Stroke patients can become housebound, leading to poor mental health, isolation and misery. 14 This can be devastating for patients and carers, and increase their reliance on home visits from medical staff, home care, social services and home adaptations. Stroke tends to affect older people, median age 77 years [interquartile range (IQR) 68–84 years],15 and, as outdoor mobility – including walking outside – declines with age, mobility disorders may also be due to impairments and social factors associated with ageing and comorbidity. People aged ≥ 80 years of age make half the number of outdoor journeys and travel less than one-quarter of the distance of those aged 50–54 years. 16 There is evidence that elderly people find it difficult to participate in transport services, owing to an inability to carry heavy loads and a fear of crime when outside at night. 14 People who are dependent on walking frames are, on average, getting out of the house less than twice each week. 17 Outdoor mobility is usually achieved by a combination of walking, cars and public transport, with very few people using specialist transport such as the provision of a taxi service for people with disabilities. 16 ^, 18

Specific outdoor mobility rehabilitation interventions exist for people with limited vision, learning disabilities and those who use wheelchairs19 but these are not routinely used for people who have had a stroke. The National Clinical Stroke Guidelines do not contain any evidence-based recommendations to guide therapists in how to treat outdoor mobility limitations. 20 However, the clinical guidelines recommend that stroke patients are encouraged to take physical exercise, as there is an increasing body of evidence that exercise is of benefit to stroke survivors. 21 In the UK the routine treatment for outdoor mobility problems is to provide information in a leaflet and verbally, delivered by a health-care professional. A Cochrane review22 concluded that the passive provision of leaflets is not effective and leaflets can be difficult to understand after a stroke. It is more likely that a multimodal rehabilitation intervention that includes exercises to decrease impairments (these can be physical and mental), education to provide information and behaviour change regimes, use of adaptive equipment and support from other people, both formal or informal sources, would be more effective at improving outdoor mobility. This study aimed to fill this evidence gap.

Justification for the current study

An outdoor mobility intervention for people with stroke was developed using qualitative interview findings, published literature, correspondence with the Department of Transport and expert opinion. 23 This intervention was evaluated in a single-centre randomised controlled study. 24 The study found clear benefits in outdoor mobility for people who received the intervention. The patients who received the intervention took twice as many journeys, many of these walking, as those in the control group, 4 and 10 months after recruitment into the study, and were significantly more likely to be satisfied with their outdoor mobility activity. Although the study was based on a real clinical need, recruited to target, had excellent follow-up and was published in a peer-reviewed journal, it had some limitations. The intervention was delivered by a single therapist, who was a stroke specialist, with experience in the delivery of community-based treatment. It was delivered in one UK city and no health economic evaluation was completed. Although this study has already influenced practice, alone it is insufficient to inform evidence-based guidelines.

Thus, the next step was to conduct a multicentre randomised controlled trial (RCT), using the lessons learned from the single-centre study. We completed a multicentre RCT to try and answer the following questions.

1. Whether:

   1. the results of the pilot study were generalisable to other therapists and other sites.

   2. the intervention could be implemented across a health system.

   3. the intervention improves overall health and, if so, whether such an approach is conventionally cost-effective.

Structure of the Health Technology Assessment monograph

The monograph has been separated into methods and results for the randomised controlled study, including delivery of the intervention and clinical effectiveness, followed by methods and results for both the economic evaluation and the qualitative substudy. Finally, all results are discussed, followed by overall conclusions.

Appendices include the summary of the intervention manual and the statistical analysis plan.

Summary of study design

The Getting out of the House Study was a multicentre, parallel-group RCT comparing clinical effectiveness and cost-effectiveness for two groups, an intervention group and a control group. The methodology used was, as far as possible, a replication of that used in the single-centre study. 24 Figure 1 summarises the study design. Patients aged ≥ 18 years, who had experienced a stroke > 6 weeks previously were considered initially eligible for the study. The majority of patients were contacted by a patient invitation letter sent from either their general practitioner or from the local community rehabilitation or local hospital stroke service register. If interested, patients replied to their local research team, who contacted them and screened them by telephone call to further determine eligibility. Final confirmation of eligibility and subsequent consenting was carried out by the research assistant (RA) at the patient’s home. Following consent, a baseline assessment was completed and all participants received the control. They were provided with travel diaries in the form of 12 months of ‘travel calendar’ to record the number of journeys that they made and any falls that they had. All participants were then randomised by the local therapist, using the web-based randomisation system that was controlled by the Nottingham Clinical Trials Unit (NCTU), to either targeted outdoor mobility therapy (the intervention) or no further therapy contact (control). Those randomised to the intervention received up to 12 visits over a maximum of 4 months (from baseline). No further therapy contact was received after 4 months, allowing 2 months before the primary and secondary outcome data were collected. Outcomes were assessed at 6 and 12 months after recruitment by postal questionnaire and by monthly travel diaries. Local RAs blinded to treatment allocation were available to assist the participant with completion of questionnaires if needed. RAs recorded incidents where they were unblinded. A subset of participants at a single site were asked to participate in a nested qualitative study investigating confidence issues surrounding stroke.

FIGURE 1.

Study design flow chart. GP, general practice.

Primary objective

To test the clinical effectiveness and cost-effectiveness of treating people who have had a stroke with an outdoor mobility rehabilitation intervention in addition to routine care compared with routine care alone.

Secondary objectives

The secondary objectives were to measure whether the intervention was associated with:

• improved:

  • mobility in and outside the house

  • patient well-being

  • participation in everyday activities

  • carer well-being

  • health-related quality of life.

Primary outcome measure

The primary outcome measure was the Social Function domain score of the Short Form questionnaire-36 items, version 2 (SF-36v2)25 measured at 6 months, as recorded in their questionnaire response. This is one of the eight domains of the SF-36v2 and was scored and transformed on to a scale of 0 (worst possible health state) to 100 (best possible health state).

Secondary outcome measures

The secondary outcome measures were:

1. functional activity in participants measured by the Nottingham Extended Activities of Daily Living (NEADL) scale26 ^, 27

2. mobility reported by participants in the completion of the Rivermead Mobility Index (RMI)28

3. the number of journeys as recorded by participants in the travel calendars

4. satisfaction with outdoor mobility (SWOM) as reported by participants in the completion of a yes/no question: ‘Do you get out of the house as much as you would like?’

5. psychological well-being as reported by participants in the completion of General Health Questionnaire 12 (GHQ-12). 29

6. carer psychological well-being as reported by participants in the completion of GHQ-1229

7. health-related quality of life as reported by participants in the completion of European Quality of Life-5 Dimensions (EQ-5D)30 and Short Form questionnaire-6 Dimensions (SF-6D)25 (based on a subset of questions from the SF-36 v231)

8. the resource use of health and social care, carer input and provision of equipment as reported by participant in the completion of the service use questionnaire and data collected relating to intervention visits

9. participant mortality (death data) as collected from NHS Information Centre (IC)/NHS Central Register.

Recruitment process

There were three methods of patient identification: searching general practice (GP) databases, searching stroke registers in secondary care hospitals, community hospitals or primary care community teams and approaching patients attending post-stroke outpatient clinics as they were discharged from rehabilitation. If the search team also had access to local stroke service rehabilitation records they cross referenced for any active stroke-related rehabilitation that may be ongoing.

All potential participants received a version of the participant information sheet (PIS) prior to the baseline visit and had sufficient time to consider the information. In addition, if required, an aphasic PIS and a summary PIS were available for participants and their carers.

Other recruitment strategies included placing adverts within local newspapers, local trust publications and relevant websites (e.g. the Stroke Association), establishing a study website, various articles within local trust publications and local press, visiting local stroke groups and widespread distribution of the study poster to relevant areas (e.g. GPs, rehabilitation teams, stroke groups, etc.).

Sample size

Our sample size calculations were based on the primary outcome measure, the Social Function domain of the SF-36v2 at 6-month follow-up. Although this was not used in the pilot study, a recent study had suggested a minimally clinically important difference (MCID) for the Social Function domain was 12.5 points. 32 The estimate of the standard deviation (SD) was taken from Brittle’s study33 and this closely matched the standard deviation obtained by assuming that the distribution of the nine possible integer-valued scores followed a roughly right-angled triangular distribution (i.e. that was positively skewed). This followed the general approach suggested by Deming34 for schematic distributions. Assuming a power of 90% and a two-sided significance level of 5%, we estimated that to detect a difference in mean SF-36 scores of 12.5 points, assuming a common SD of 28.2 points,33 a sample size of 135 patients per group was required. This calculation assumed an attrition rate of 20% over a 6-month period.

Clustering by delivery of treatment was allowed for by generating simulated data to mimic the multilevel structure of the proposed study, with site-specific variation between therapists. The likely existence of sharing of therapists by patients was addressed by a multiple membership model, and the variance of the treatment effect so found was compared with that of a regression model ignoring clustering (both models treating centre as a fixed effect). The data sets and analyses were performed in Stata v10 (StataCorp LP, College Station, TX, USA). The variance inflation observed was insensitive to variation in the simulated between-site variance and the average between-therapist variance, and a rounded value of 2.5 was selected as the multiplier for a sample size based on a naive analysis. After the allowance for clustering by delivery of treatment, a sample size of 338 participants per arm was required, with an overall sample size of 676, allowing for 20% lost to follow-up.

Setting and locations

The study was coordinated by the NCTU and involved 15 sites from across England, Scotland and Wales. Initially seven sites were planned but during the course of recruitment an additional eight were added.

The sites were a mixture of settings, split in broad terms as follows.

Eligibility criteria

Patients were eligible for the study if they provided written informed consent and if they:

1. were aged ≥ 18 years

2. had experienced a stroke at least 6 weeks previously, and

3. wished to get out of the house more often.

Patients were not eligible for the study if they were:

1. not able to comply with the requirements of the protocol and therapy programme – in the opinion of the assessor

2. still in post-stroke intermediate care or active rehabilitation, or

3. previously enrolled in this study.

Patients who had suffered a transient ischaemic attack were not included.

Screening and baseline assessment

The majority of preconsent screening was undertaken over the telephone by the RA in response to a patient reply to a patient invitation, and involved a general discussion of the study background and participation requirements. In addition, key eligibility questions were asked in relation to wishing to get out of the house more often and establishing potential outdoor mobility goals related to the intervention manual. Following this process, if the potential participant remained eligible then a baseline visit would be arranged.

The baseline visit was conducted in the potential participant’s home. The visit consisted of four elements: first, confirming eligibility against inclusion and exclusion criteria; second, consenting (see Consent, below); third, baseline data collection; and, fourth, delivery of the control (see Control, below).

Only limited numbers of data were collected, including basic demographics, time since stroke and contact details.

Consent

Participant information sheets were available in several different formats, including full length, abbreviated leaflet style, summary and aphasic. In practice, a combination of all four of these were often used, as appropriate, for each individual participant. Only people who had the mental capacity to consent to participation, defined against the criteria in the English Mental Capacity Act,35 were eligible to take part. If there were communication problems then the participant’s carer or relative was involved in the process. In addition, owing to potential physical limitations with completion of the consent forms, it was acceptable for the participant to mark the consent form, accompanied by a witness signature to complete the consent process. If the physical challenges were more severe then a witness (usually a member of the participant’s family, carer or neighbour) could complete the consent form on the participant’s behalf.

During the baseline visit, carer information sheets and questionnaires were provided to all carers. They were allowed to complete them immediately or later, and the process of completing and returning the questionnaire was considered to be implied consent.

Control information

All participants in the study received the control information during the baseline visit by the RA. The control information was provision of verbal and written local mobility and transport information. This information was site specific. Each site collated a pack of local information and leaflets as guided by the research team. They were asked to include information about bus times, local community transport, taxi services, wheelchair services, disabled persons’ car badges, wheelchair borrowing schemes and mobility equipment. These individualised packs were given to the participant after their content had been discussed.

Randomisation

Following consent and completion of the baseline assessments and delivery of the control information, the participant’s details were passed to the local therapist. The therapist accessed the remote, secure web-based electronic case report form (eCRF) and randomisation system developed and maintained by the NCTU and entered basic demographic details. Once these details had been entered irrevocably into the system, the group to which the participant was randomly allocated was provided to the therapist. Randomisation was created using Stata/SE version 9 statistical software with a 1 : 1 allocation to intervention group or control. Participants and therapists were aware of the intervention allocation, whereas the RA responsible for assisting with collection of the outcome measures was kept blinded to the allocation throughout the study.

Randomisation was based on a computer-generated pseudorandom code using random permuted balanced blocks of randomly varying size, set up and maintained by the NCTU in accordance with its standard operating procedure and held on a secure server. The randomisation was stratified by age (< 65 years and ≥ 65 years) and site. Sixty-five years of age was chosen as a cut-off point because Mobility Allowance – a monetary allowance – was no longer available for people aged > 65 years and over. Access to the sequence was confined to the NCTU Informartion Technology (IT) Manager. The sequence of treatment allocations was concealed until all participants had been randomly assigned to a treatment group and recruitment, data collection and all other study-related assessments were complete.

If the participant was randomised to the intervention group then the therapist contacted the participant to arrange an initial goal-setting visit. If the participant was randomised to the control group the therapist would either, based on site staff preference, not contact the participant or contact the participant to explain their allocation. It was not recorded which approach was used for which participant.

Intervention

The development of the intervention followed the guidelines. 36 Qualitative interviews23 were used to identify ‘barriers and need’ theories. A group of senior and specialist therapists met to discuss the interviews and developed an intervention based on the results, their clinical skills and training. The intervention training manual that was used to train therapists in each site was developed using a systematic approach. Initially, a literature review was performed using the search strategy for the following terms ‘rehabilitation’, ‘stroke’, ‘occupational therapy’ and ‘outdoor mobility’, with the results reviewed by a panel of expert stroke clinicians from which a draft training manual was developed. This was then reviewed by a focus group of therapists (n = 15) who had either delivered the intervention in the pilot study or were clinical experts in stroke. The intervention training manual used for this study contained:

• standardised assessments

• case vignettes of treatment plans

• goal planning and activity analysis guidelines

• protocol for a first outing walking, using the bus and using a taxi

• checklist of benefits and barriers to going outside

• motivational and confidence-building strategies

• examples of skills needed to catch a bus or train

• examples of skills needed to be able to operate an outdoor mobility scooter.

The aim of the intervention was to increase outdoor mobility participation by alleviating physical difficulties, developing skills to maximise the individual’s potential and overcoming psychological barriers. The main component of the intervention was for participants to repeatedly practise outdoor mobility. This included buses, taxis, walking, voluntary drivers and mobility scooters until they felt confident to go alone or with a companion. The number of intervention sessions depended entirely on the participant. If they felt they did not require any further intervention, for whatever reason, then the intervention stopped. If they felt they required additional intervention for whatever reason, they could continue the intervention up to a maximum of 12 visits. We recorded the duration of each intervention visit, including the time taken to deliver the intervention, and travel to and from the participant’s home. A description of the intervention has been published37 and a training manual developed. A more detailed summary of the training manual can be found in Appendix 2 .

Training therapists to provide the intervention

Therapists in each site were trained by Pip Logan [chief investigator (CI) and sole therapist in the pilot study] to deliver the intervention using the intervention training manual and a standard presentation over the course of 2 hours. Following this face-to-face training, the majority of therapists attended an update session each year. On an ongoing basis they were able to e-mail other therapists on the study to discuss treatments and were able to contact the study CI with any queries relating to the intervention.

Each therapist was registered on the eCRF database and when the record of a particular intervention visit was added to the eCRF then a therapist, or therapists, had to be assigned to that particular visit, therefore providing an accurate record of the delivery of the intervention, which could be correlated against the training records.

Data collection

There were four methods of data collection: eCRF, questionnaire booklets, travel diaries and intervention records. The NCTU performed quality control checks on all aspects of data collected and entered onto the eCRF to ensure accuracy and completeness. Specifically, a 100% check of primary end points and a 10% check of all other data were completed.

Intervention records

As well as the intervention duration being recorded in the eCRF, therapists also completed a paper intervention record form detailing goals set, visit-by-visit clinical details plus a breakdown of therapy activities. These were collected at the end of the study and collated into a separate database. Therapists were trained to use the form as part of the intervention training. The type and duration of intervention within any given visit were recorded under the following headings: goal setting, mobility, confidence, adaptive equipment, information, other rehabilitation and referral on to other agencies. For each intervention visit the therapist recorded how many minutes they spent on each activity, they listed the agreed outdoor mobility goals and kept running records of each treatment session as they would in routine clinical care. The intervention records were kept in the NHS clinical setting until the end of the study when they were copied and collated by the central coordinating centre.

Treatment fidelity

To assess the fidelity of the intervention therapy provided, 20% of clinical records were monitored (10% of all participants). A RA who was independent of the site visited the site and checked the treatments being delivered against a predefined checklist by accompanying the therapist on a number of treatment visits and by monitoring the intervention records. The last question on the checklist (a yes/no question as to whether the assessor believed that treatment provided met the required standard) was used to indicate whether the intervention had been delivered as specified and, therefore, implied fidelity of treatment.

Adverse events/safety evaluation

The main risk identified from this study was the potential to increase the chance of a participant having a fall, as a result of increased mobility. For adverse event purposes we adopted the following definition: ‘A recordable adverse event is any fall that occurs during or following the first outdoor mobility intervention and for the remaining period of intervention in the study that specifically requires the assistance of a health-care professional’. If these criteria were met then an adverse event form was completed. We adopted the following approach to capture this information – the therapist would ask, during an intervention visit, the following questions:

• ‘Have you had any falls since my last visit?’

• If yes, ‘How many?’

• ‘How many required health-care professional help?’

Therefore, adverse events were only recorded from the intervention group, as the control group did not receive any visits post baseline. No other adverse events were collected. The occurrence of a serious adverse event as a result of participation within this study was not expected and no serious adverse event data were collected.

In order to capture information from both groups for comparison and a further measure of safety, we adopted a second approach. Participants indicated a fall on the travel diary by marking or circling the preprinted ‘f’, denoting that ≥ 1 fall had occurred for that participant on that day. These would not be classed or recorded as adverse events. Also, a comparison was made of any untoward changes in the well-being score of all participants by comparing the baseline GHQ-12 score with the 6- and 12-month score.

In the event of a pregnancy occurring in a study participant then they were allowed to continue in the study regardless of which arm they had been randomised to.

Participant retention and withdrawals

To try and reduce the bias in participant retention caused by people wishing to withdraw before the primary end point because they were not allocated to the intervention group, we allowed participants to stop completing the travel diaries and asked them whether they would be happy to remain in the study and complete the 6-month questionnaire.

No specific withdrawal criteria were defined for this study. If a participant left the study prematurely (i.e. prior to completion of the protocol), the primary reason for discontinuation was determined and recorded if at all possible. Withdrawn participants were not replaced. Participants were made aware (by the information sheet and consent form) that should they withdraw, the data collected prior to the withdrawal date would not be erased and would still be used in the final analysis.

For this study, and in reference to the CONSORT (Consolidated Standards of Reporting Trials) diagram (see Figure 3 ), the following definitions were applied in relation to the participants and the data:

Withdrawn consent The participant formally withdrew from the study and no further data were collected from that point. This was measured in relation to completion of 6- or 12-month follow-up and not the time of withdrawal, for example, if a participant withdrew after 7 months and did not complete their 6-month follow-up then they would be recorded as ‘withdrawn prior to 6-month follow-up’.

Lost to follow-up The study coordinating centre and/or local site staff were unable to contact the participant. This was recorded in relation to completion of 6- or 12-month follow-up as above.

No follow-up data The study coordinating centre and/or local site staff were in contact with the participant but follow-up data were not received; however, the participant was not formally withdrawn from the study. These participants at 6-month follow-up were classed as ‘no follow-up data’ on the CONSORT diagram and continued to participate in the study. These participants at 12 months’ follow-up were also classed as ‘no follow-up data’ on the CONSORT diagram.

Statistical methods

Full descriptions of the statistical methods of analysis are detailed in the statistical analysis plan (see Appendix 1 ).

Intervention and goals descriptive analysis A description of the components of the intervention was undertaken with the type of intervention therapy received by participants (e.g. mobility, goal setting, confidence, etc.) summarised in terms of number and percentage of participants who received the different types of therapy sessions and the mean, SD, median, IQR, and the minimum and maximum of the number of sessions for each type of therapy session. The goals set by each participant during the intervention sessions were recorded verbatim and this information was then sorted into categories of the goal types. These data were then analysed through calculating the number and percentage of participants who set each type of goal.

Compliance in reference to CONSORT

Compliance in this study was effectively a measure of completeness of follow-up data. Baseline questionnaires were required to be completed before randomisation so that baseline CONSORT-presented numbers randomised. The CONSORT diagram presented compliance for this study as the number of returned questionnaires for the 6- and 12-month follow-ups, regardless of completeness of the questionnaire booklets.

For individual analyses of outcome measures, as the analysis relies on a comparison between follow-up data and the baseline data, the ‘n’ presented in the results section was a measure of the number of participants who completed the outcome measure at both baseline and follow-up. Data from participants who answered some, but not all, of the questions within a questionnaire based outcome measure were still included in the analysis; however, if the whole of the questionnaire was missing then their data were not used.

Study management and oversight

A number of committees were assembled to ensure the management and conduct of the study, and to uphold the safety and well-being of participants.

Study recruitment and follow-up

The study recruited 568 out of 506 (112.3%) of the required sample size from November 2009 to August 2011. Participants were recruited from 15 sites across England, Scotland and Wales, with an average recruitment of 38 participants (range from 5 to 99) per site, with nine sites recruiting > 30 participants. The participant involvement in the trial ended in August 2012, following completion of recruitment and follow-up. Figure 2 shows that, after an initial lag phase, steady recruitment was achieved with no noticeable seasonal variation.

FIGURE 2.

Recruitment rate.

Table 1 provides a breakdown of screening figures collected from all sites, in terms of number of invitations sent, number of ‘yes’ replies, number of home screening visits, number randomised and the proportion of recruits per 100 invites. The different approaches were used to varying extents: GP-based approaches being responsible for recruiting 158 out of 568 (27.8%) of randomised participants at a rate of 2.5 per 100 invites, and stroke register-based approaches recruiting 410 out of 568 (72.2%) of randomised participants at a rate of 8.5 per 100 invites. The stroke register data includes participants recruited at outpatient clinics.

Follow-up (CONSORT)

Figure 3 shows the CONSORT diagram for the study. The identification of participants was from 11,126 invites, either by letters of invitations or face-to-face approach. The exact breakdowns were not recorded; however, the majority were by letter of invitation. We had ‘yes’ replies from 1448 out of 11,126 (13.0%) approaches to participate in the study with 9678 out of 11,126 (87%) either not responding or providing negative replies. We did not record the number of ‘no’ replies. After initial pre-consent screening, usually by telephone, a further 596 out of 11,126 (5.4%) were considered ineligible. The main reason for ineligibility was that the potential participants felt they got out of the house as much as they wished already. Therefore, 852 out of 11,126 (7.7%) had a further screening visit in their own home from the RA. Overall, 568 out of 852 (66.7%) were found to be eligible to take part. Of the 11,126 letters sent, 568 people were included (5.1%). Of the 284 out of 11,126 (2.6%) who did not enter the study, only 1 out of 11,126 (0.01%) explicitly refused to participate (owing to their desire to be in the intervention group only).

FIGURE 3.

Final CONSORT diagram. a, Participant remained in the trial but no data were collected at that time point.

The baseline questionnaire was completed by 567 out of 568 (99.8%) participants, with the one outstanding being left with the participant and never being received by the study coordinating centre.

Following randomisation, 287 out of 568 (50.5%) participants were allocated to the intervention group and 281 out of 568 (49.5%) to the control group. In the control group, 1 out of 281 (0.4%) participants received two intervention visits in error. In the intervention group, 281 out of 287 (97.9%) of participants received at least one intervention visit. There was no evidence of crossover between the two groups.

Six-month follow-up was measured by the receipt of the 6-month questionnaire booklet by the research team. For the intervention group, 264 out of 287 (92.0%) reached 6-month follow-up. Of the 23 out of 287 (8.0%) who did not reach 6-month follow-up, 3 out of 287 (1.0%) were lost to follow-up, 14 out of 287 (4.9%) withdrew consent and 4 out of 287 (1.4%) died. A further 2 out of 287 (0.7%) did not complete the follow-up but remained in the study, with 266 participants remaining in the intervention group after 6-month follow-up. For the control group, 239 out of 281 (85.1%) reached 6-month follow-up. Of the 42 out of 281 (14.9%) who did not reach 6-month follow-up, 8 out of 281 (2.8%) were lost to follow-up, 29 out of 281 (10.3%) withdrew consent and 5 out of 281 (1.8%) died. Therefore, there were 239 participants remaining in the control group after 6-month follow-up.

Completion of 6- and 12-month follow-ups was defined as return of the fully/partially completed questionnaire booklet to the NCTU. It does not indicate the level of completeness. Six- and 12-month results for individual measures presented later in the chapter indicate the number of participants from which we have analysable data.

There was a differential follow-up rate between the two groups for the 6-month follow-up, with 92.0% collected for the intervention group and 85.1% collected for the control group. However, these were both less than the predefined 20% attrition rates.

Successful data collection at 12-month follow-up was measured by receipt of the 12-month questionnaire booklet. For the intervention group, 232 out of 287 (80.8%) reached 12-month follow-up. Of the 34 out of 287 (266 – 232 = 34; 11.8%) who did not reach 12-month follow-up, 3 out of 287 (1.0%) were lost to follow-up, 17 out of 287 (5.9%) withdrew consent and 8 out of 287 (2.8%) died. A further 6 out of 287 (2.1%) did not complete the follow-up but remained in the study. For the control group 211 out of 281 (75.1%) reached 12-month follow-up. Of the 28 out of 281 (239 – 211 = 28; 10.0%) who did not reach 12-month follow-up, 4 out of 281 (1.4%) were lost to follow-up, 15 out of 281 (5.3%) withdrew consent and 7 out of 281 (2.5%) died. A further 2 out of 281 (0.7%) did not complete the 12-month follow-up but remained in the study.

As with the 6-month follow-up, there were differential follow-up rates between the two groups for the 12-month follow-up. A total of 232 out of 287 (80.8%) of questionnaires were collected for the intervention group and 211 out of 281 (75.1%) collected for the control group. Although the control group follow-up rate was within the defined 20% attrition rate, the overall number of participants with 12-month follow-up data (n = 443) was within the threshold to ensure that the study had adequate power.

Table 2 summarises the results of who completed the questionnaire and indicates a consistent proportion of participants completed the questionnaires themselves, whereas at 6 and 12 months there were consistent completion rates for both carer and other (16% and approximately 37%, respectively). The ‘other’ completions at baseline were due to the presence of the RA.

TABLE 2 - Proportion of who completed baseline and follow-up questionnaires

No baseline questionnaire data were returned for one participant.

Questionnaire	Who completed the questionnaire
	You (%)	Carer (%)	Other (%)
Baseline (n = 567a)	234 (41.3)	32 (5.6)	301 (53.1)
6-month follow-up (n = 503)	230 (45.7)	81 (16.1)	192 (38.2)
12-month follow-up (n = 443)	208 (47.0)	74 (16.7)	161 (36.4)

Baseline characteristics

Table 4 presents a summary of key baseline characteristics of each group. Baseline characteristics of the sample showed the majority of participants to be women, living with others, with a mean age of 71 years (SD 12.1 years). At baseline there was a slight gender imbalance, with a higher proportion of men in the control group than the intervention group (47% vs. 42.2%). Residential status was well balanced between groups with only a slightly higher proportion living alone in the control group (35.2% vs. 33.4%). The average time since stroke was 37 months (SD 43.8 months) for the control group and 43 months (SD 60.1 months) for the intervention group.

Baseline scores for mobility, activity measures, GHQ-12 and SWOM were similar in the two groups. However, for the primary outcome measure of quality of life (social functioning score), the control group had a higher mean (50.1 vs. 45.9) and median (50 vs. 37.5) than the intervention group.

Satisfaction with outdoor mobility scores indicated that overall 93.3% of participants were not currently satisfied with their level of outdoor mobility. The remaining participants who indicated SWOM (n = 38) were spread across both groups, in all sites except one, and had no other unusual characteristics.

It is important to clarify the relationship between the ‘SWOM’ (Do you get out of the house as much as you would like?) question as part of the baseline questionnaire and the eligibility criteria of ‘Wishing to get out of the house more often’. On 38 out of 568 (6.7%) occasions, 20 out of 281 (7.1%) in the control group and 18 out of 287 (6.3%) in the intervention group, the participant indicated that he or she met the eligibility criteria during the consent process but answered ‘Yes’ to the ‘SWOM’ question during completion of the baseline questionnaire. On further investigation it appeared that certain participants were viewing these questions within a different context. The eligibility question was related to aspirational view of getting out of the house (i.e. ‘Wishing to get out of the house more often’), whereas the SWOM question was related to day-by-day coping views of getting out of the house. Hence these participants were not classed as ineligible and were included in the analyses.

Delivery of the intervention

Number and duration of intervention sessions

The intervention group received a median of seven intervention sessions (IQR 3–11 sessions), mean 6.80 sessions (SD 4.01 sessions). Figure 4 illustrates the distribution of intervention visits received by participants, ranging from zero intervention sessions (6/287, 2.1%) to the maximum 12 (61/287, 21.3%); 138 out of 287 (48.1%) received less than the median of seven visits, with 149 out of 287 (51.9%) receiving ≥ 7 visits. These were calculated from eCRF intervention visit data.

FIGURE 4.

Range of intervention visits.

Of the 287 intervention participants, paper intervention records completed by the therapists were returned for 269 out of 287 (93.7%) participants, 264 out of 287 (92.0%) of whom had received at least one treatment session. The median duration in total, in minutes, of intervention provided for these 264 participants was 369.5 minutes (IQR 170–691.5 minutes), mean 454.6 minutes (SD 352.20 minutes). These were calculated from intervention records data.

Numbers analysed

Figure 2 illustrates the flow of participants and their data; however, it does not provide the details on an outcome-by-outcome basis. A partially completed outcome at the particular follow-up was required for unadjusted measures. In order for any unadjusted outcome measure (apart from travel journeys) to be calculated, the particular measure must be at least partially completed at both baseline and at the particular follow-up. For travel journeys, the participant had to return at least one travel diary to be included in either unadjusted or adjusted analysis. Table 7 details the number of participants analysed for both adjusted and unadjusted outcome measure analysis.

Primary outcome

The primary outcome was the Social Function domain within the SF-36v2 relating to an improvement in participant’s quality of life. The predefined MCID was 12.5. 32

Table 8 summarises the primary outcome analysis. The variability of the social function score was similar in the two groups although the mean score was slightly higher in the intervention group (47.0) at 6 months compared with the control group (43.9). The adjusted difference in means between groups was 4.630 with a 95% credible interval of –0.549 to 9.848. This suggests a slightly higher social function score in the intervention group but this was not significant and it is less than the pre-defined MCID. The ICCs for the therapist (ICC = 0.0051) and site effects (ICC = 0.0099) are small, and less than we anticipated in our sample size calculations.

Secondary outcomes at 6 months

Table 9 summarises the secondary outcome analysis at 6 months. The unadjusted mean scores in both groups were similar at 6 months for all secondary outcome measures. In the adjusted analyses there was a statistically significant difference observed between groups for travel journeys, with the intervention group being 42% more likely to make a journey than the control group [rate ratio 1.42, 95% confidence interval (95% CI) 1.14 to 1.67]. There were no other outcome differences between groups.

There was evidence of a therapist effect on the travel journeys taken but not for any of the other outcome measures. ICCs for therapist and centre effects were small, with ICCs for therapist effect being no greater than 0.0289 and ICCs for site effect being no greater than 0.0234. Therapy effect and site effect could not be calculated for travel journeys.

The other domains from the SF-36v2 were also analysed at 6 months and showed no significant difference between groups.

Exploratory/other analyses

Adverse events

Adverse events records (i.e. a fall that required the assistance of a health-care professional) were collected from only participants in the intervention group over the course of delivering the intervention visits. There were 20 adverse events from 17 participants, with the majority of falls occurring at home. Two were recorded as ongoing, with the average mean duration of event being 5.6 days and median duration of 1 day (range 1–44). Overall, there was no effect on the delivery of the intervention and only one led to permanent discontinuation of the intervention.

Overall, 24 participants died, 12 in each group, indicating that the intervention group did not have an increased risk of death compared with what would be expected for this patient group. As part of the safety analysis there was also no significant difference in GHQ-12 score observed between the groups.

Protocol deviations

There were 68 protocol deviations recorded, with 37 out of 68 (54.4%) for visits not performed within the 4-month window (the majority of these were as a result of adverse weather conditions or temporary participant or therapist unavailability). However, from eCRF intervention data there were a total of 83 visits delivered outside the 4-month window, so there was an issue recording these as protocol deviations.

Twenty-five out of the 68 participants (36.8%) recorded other intervention therapy, which refers the intervention being delivered via non-protocol-defined methods (in all of these cases the intervention was delivered either by telephone or letter).

One out of 68 participants (1.5%) in the control group received the intervention (two visits); 1 out of 68 participants (1.5%) was in active rehabilitation at point of recruitment; and 1 out of 68 participants (1.5%) was an eligibility deviation, as the participant was unwell and not fit to receive treatment, whereas 1 out of 68 participants (1.5%) had a consent issue that was later resolved. Finally, 2 out of 68 participants (2.9%) had an intervention delay owing to unforeseen circumstances.

We considered these all to be minor deviations and that they were unlikely to have any effect on the outcome measure. As a result, no action was taken and all of these participants remained in the study and in the final analysis.

Concealment of allocation

There was a total of 223 RA-assisted participant visits at 6 months (see Table 15 ), for which the participant-reported primary outcome measure was collected. We received blinding assessments for 171 out of 223 (76.7%) [intervention group 88 out of 171 (51.5%); control group 83 out of 171 (48.5%)] RA-assisted participant visits at 6 months ( Table 16 ). The RA was unblinded for 87 out of 171 (50.9%) of those visits, with 13 out of 171 (7.6%) unblinded prior to the visit and 74 out of 171 (43.3%) unblinded during the visit. The RAs were unblinded more frequently for participants in the intervention group (48/87, 55.2%) than for those in the control group (39/87, 44.8%), although this is not indicative of any significant difference in unblinding rates between the two groups.

Summary

• The study reached its recruitment targets and achieved strong retention rates at 6 months.

• Differential follow-up occurred but not to an extent as to affect the power of the study. The attrition rates were greater within the first 6 months of follow-up.

• The quality of life (social function) measure (primary outcome) showed no significant difference between groups at 6 months or at 12 months.

• Six- and 12-month measures for functional mobility, SWOM, and participant and carer well-being showed no significant differences between groups.

• The 6- and 12-month measure of travel journeys showed a significant difference in favour of the intervention group when the therapist and site effect was taken into consideration.

• There was no evidence of a therapy or site effect in any of the outcome measures at either 6 or 12 months, apart from travel journeys at 6 and 12 months.

• The intervention was delivered a median of seven times across the study as a whole, with 67.3% completed to the satisfaction of the participant; however, there was considerable variation amongst the sites for both these outcomes.

• Exploratory data suggest that the more intervention visits a participant receives, the more likely they are to take more journeys beyond the completion of the intervention.

• Exploratory data suggest that the more intervention visits a participant had, the more likely they were to complete the intervention to satisfaction.

• The control group appears to have benefitted from inclusion in the study by becoming more satisfied with their outdoor mobility over time.

Health economic evaluation: methods used

This component of the study aimed to extend the evidence base by estimating for the first time the incremental cost-effectiveness of an outdoor mobility rehabilitation intervention, compared with control, from a health and personal social services perspective. In addition, carer time and certain patient-borne costs were also estimated. It was decided that medication costs would not be monitored, as it was considered that the intervention would not influence these. A within-trial analysis was conducted over a 12-month period, where an available case analyses approach41 was adopted. Thus, for each variable, we analysed all available data, which meant a different sample n was used for different variables. For example, the EQ-5D and SF-6D may have different response rates. Additionally, in the base-case analysis, it should be noted that when calculating levels of cost-effectiveness [see Cost-effectiveness, below, for a definition of incremental cost-effectiveness ratio (ICER)] we included only those participants who had both complete cost and effect data. As such, the number of participants for whom these data are available may well differ from the n for which separate cost and effect data are available.

Methods

Results

Base-case analysis

For those who had both complete cost and QALY data (based on the EQ-5D), after adjusting for covariates, the mean incremental cost (total NHS and PSS cost) was estimated to be £3413.75 (95% CI –£448.43 to £7121.00), with an incremental QALY gain of –0.027 (95% CI –0.060 to 0.007) (see Table 21 for details of the numbers included in the analysis). An ICER was not calculated for this group, as the intervention was, on average, both more expensive and less effective. With regard to the SF-6D, the incremental cost was £2393.38 (95% CI –£2017.58 to £5999.37), with an incremental effect of –0.003 (95% CI –0.016 to 0.006). The intervention was thereby estimated to be dominated by the control group. The associated CEACs are shown in Figures 5 and 6 , for the EQ-5D and SF-6D, respectively. The probability that the intervention was cost-effective was < 20% at all cost-effectiveness thresholds.

TABLE 21 - Base-case and sensitivity analyses

INB, incremental net benefit at the threshold of £20,000 per QALY. The probability of being cost-effective is also estimated at this value.

Unadjusted costs.

Adjusted results are presented along with unadjusteda results for the base case; n refers to the number of participants who had complete data for both costs and outcomes. (This is dependent on the perspective taken and outcome measure used in the analysis. Numbers for the intervention group are displayed first.)

Analysis	Outcome measure	Incremental cost (£)	QALY gain	INB (£)
Base-case analysis (total NHS and PSS costs)	EQ-5D (n = 151; 139)	3139.05a (95% CI –854.08 to 7086.78)	–0.040a (95% CI –0.094 to 0.013)	–3948.20 (6.5%),a (95% CI –8215.70 to 362.68)
		3413.75 (95% CI –448.43 to 7121.00)	–0.027 (95% CI –0.060 to 0.007)	–3944.90 (5.2%), (95% CI –7863.85 to 50.26)
	SF-6D (n = 137; 139)	1826.18a (95% CI –2259.47 to 5820.55)	–0.011a (95% CI –0.028 to 0.005)	–2053.78 (20.6%),a (95% CI –6139.58 to 2088.66)
		2393.38 (95% CI –2017.58 to 5999.37)	–0.003 (95% CI –0.016 to 0.006)	–2237.37 (18.1%), (95% CI –6191.72 to 1936.07)
Received ≥  six intervention visits (total NHS and PSS costs)	EQ-5D (n = 91; 139)	2663.38 (95% CI –1866.37 to 7415.26)	–0.036 (95% CI –0.074 to 0.003)	–6592.26 (4.8%), (95% CI –13268.98 to 104.40)
	SF-6D (n = 85; 139)	1937 (95% CI –2772.99 to 6637.36)	–0.008 (95% CI –0.021 to 0.004)	–2867.15 (22.9%), (95% CI –6844.37 to 2599.90)
MI	EQ-5D (n = 287; 281)	–202.76 (95% CI –2651.37 to 2313.30)	–0.026 (95% CI –0.050 to –0.001)	–314.15 (40.7%), (95% CI –2867.61 to 2193.86)
	SF-6D (n = 287; 281)	–454.62 (95% CI –2923.91 to 1939.63)	0.001 (95% CI –0.010 to 0.013)	483.76 (61.6%), (95% CI –1934.81 to 2963.58)
Winsorising	EQ-5D (n = 151; 139)	3088.47 (95% CI 6,35.90 to 5511.87)	–0.024 (95% CI –0.057 to 0.008)	–3570.48 (1.3%), (95% CI –6186.68 to –923.48)
	SF-6D (n = 137; 139)	2024.92 (95% CI –571.62 to 4622.48)	–0.005 (95% CI –0.014 to 0.005)	–2116.45 (9.1%), (95% CI –4748.48 to 499.28)
Overall costs	EQ-5D (n = 133; 129)	5144.81 (95% CI 823.17 to 9383.24)	–0.019 (95% CI –0.055 to 0.016)	–7273.84 (2.8%), (95% CI –13590.05 to –955.97)
	SF-6D (n = 122; 126)	3484.89 (95% CI –800.42 to 7663.75)	–0.003 (95% CI –0.014 to 0.009)	–3771.01 (8.8%), (95% CI –7663.75 to 800.42)

FIGURE 5.

Cost-effectiveness acceptability curve for the intervention (green line) and control group (black line) (base case for EQ-5D data).

FIGURE 6.

Cost-effectiveness acceptability curve for the intervention (green line) and control group (black line) (base case for SF-6D data).

Sensitivity analysis The results of each of the sensitivity analyses are presented in Table 21 . Within all these analyses it can be seen that the 95% CI surrounding the INB is never wholly positive. Thus, in line with the base-case analysis, we are unable to conclude that the intervention is significantly (p < 0.05) more cost-effective at a λ of £20,000 per QALY. Indeed, the INB was more commonly negative and there was no suggestion that the intervention was more cost-effective for those who received six or more intervention visits.

One additional point to note is that although there is some consistency in these results (at a λ of £20,000 per QALY the 95% CI surrounding the INB is never wholly positive), there is some variation in the mean estimates. For example, in the base-case analysis (based on available data), compared with control, the intervention is estimated to be (on average) more costly and less effective. Conversely, when we look at the results based on MI, the intervention is estimated to be (on average) less costly and more effective. As such, at a λ of £20,000 per QALY, there is wide variation in the probability of the intervention being cost-effective (see Table 21 ).

Summary In the base (complete)-case analysis, the mean incremental cost of the intervention (total NHS and PSS costs) was estimated to be £3413.75 (95% CI –£448.43 to £7121.00), with an incremental QALY gain of –0.027 (95% CI –0.060 to 0.007), according to the EQ-5D. This suggests that the intervention was not cost-effective. The sensitivity analyses tended to support this conclusion as, at a cost-effectiveness threshold of £20,000 per QALY, the CIs around the mean INB were never wholly positive.

Introduction

This chapter presents the aims and methods of the qualitative study, which explores the meaning of confidence after stroke, as described by the intervention participants. The principles of interpretive phenomenology analysis (IPA) were applied in both the collection and analysis phases of the study, resulting in broadening our understanding of the meaning of ‘confidence’ after having a stroke.

Aims

The aims of the qualitative study were to answer the following questions:

1. How does having a stroke affect self-confidence?

2. How do stroke survivors describe their experiences of regaining confidence after stroke?

3. What do stroke survivors identify as barriers to regaining confidence?

Sampling strategy and recruitment

All participants were selected from the ‘getting out of the house’ trial as IPA recommends that participants should be experts in the phenomenon being studied. ‘Lack of confidence’ was cited in the single centre24 as a reason for not getting out of the house, so it was felt that participants in the multicentre study were likely to have a perspective of individual confidence. To achieve maximum diversity a purposefully selected sample, ranging from no symptoms at all after stroke to severe disability, were recruited. The Modified Rankin Scale63 ^, 64 was used to identify this range, which was considered reflective of the stroke population. Ten potential participants were contacted by the qualitative researcher and invited to consent. All 10 participants agreed to be interviewed and a willingness to tell their stroke story was observed.

Participant sample characteristics

The sample was drawn from two trial sites for geographical convenience. Five men and five women were included in the study. One presented with no symptoms after stroke, three with slight disability, four with moderate disability, and two with moderately severe disability. Five lived alone, three lived with their spouses, and the remaining two lived with their spouses and children. Nine participants were of white British origin and one was of black Caribbean origin.

Data collection: interviewing approach

Semistructured, in-depth interviews that sought the perceptions of stroke survivors were the favoured method of data collection. It is advocated that in-depth interviews are the best ways to attain rich, comprehensive, first-person experience. 65 Interviews were conducted in participants’ own homes, which aimed to provide a safe and familiar context. A reflective journal to capture feelings and thoughts throughout the interview process was maintained.

An interview guide was developed for two pilot interviews, and improved for next eight interviews. This proved a useful tool for steering the interview. However, the first interview question elicited the majority of the data. ‘Tell me about your stroke, what happened when you had your stroke?’ The natural responses and flow of the interview as a result of this question, enabled participants to articulate meanings around losing confidence and regaining confidence, through their experiences, in their own words. Ten completed interviews were transcribed verbatim, using digital dictation transcription software. Transcripts reflected words, laughter, significant pauses and silences.

Data analysis

The framework for the data analysis was selected on the basis of the methodology. A six-stage process following IPA principles was chosen in favour of using a computer software package, such as, NVivo. IPA is interested in understanding the content of the data, rather than measuring frequency of words, or imposing a more tapered approach to the data. Therefore, principles advocated by an IPA expert65 were applied, and six-stage analysis process followed:

1. Reading and re-reading the data, making initial notes in margins.

2. Initial noting, taking one participant’s data at time, applying no rules and, therefore, making this stage as exploratory as possible.

3. Key data were then captured during the next analytical stage and the development of emergent themes progressed.

4. Stage four involved looking for patterns and connections across emergent themes and interpretation within these data was applied.

5. Stage five involved a repetition of stages 1–4 across all participants.

6. The final stage was a process that aimed to capture the essence of each individual story and also seek out differences and similarities within the data.

This process was audited by an experienced researcher in order to verify that all stages had been followed, adding to the trustworthiness of the data findings.

Presentation of the findings

The findings section follows with six key emergent themes that describe the phenomenon of confidence after a stroke. Although each participant provided a unique account, surprisingly, the emergent themes identified shared many concepts, despite difference in stroke impairments and personal context. The themes represent the essence of ‘confidence’ for the participants.

As there is an argument for the definition of confidence being different dependent upon who is asked,66 embedded in the interview data were a direct question about what confidence meant to participants in this study, conducted on the basis of providing some introductory data. Box 1 illustrates these findings:

To three of the participants, confidence is about doing, choice and engaging in everyday activity. Two participants struggled with its definition in this direct context; however, were able to define the impact of confidence elsewhere in the data. A further two immediately describe losing their confidence and to these participants, confidence has a negative connotation and relates to fear and safety. Further analysis and interpretation is embedded within the themes that follow.

‘Robbed of life’

The notion that having a stroke questions who you are was articulated by many of the participants. Skill loss, decreased competency and lack of engagement in activities were described as contributing to a general feeling of being a lesser person, and uncertainty as to how competent one feels after having a stroke.

June illustrates a perceived link between activity and identity, associating what she does, to who she is:

Can’t walk far, can’t play badminton. I’m just a totally different person.

June 11.9

The data indicated that the participants’ sense of competence after stroke was challenged. Not feeling able to engage in previous, often familiar, skills or roles, such as ‘washing the pots or walking the dog [laughter]’ (Ryan 9.17) contributed to loss of confidence. However, embedded in the data, successfully regaining skills contributed to increased competence and self-beliefs, resulting in a regaining of confidence in their abilities.

Fear of having another stroke

Some element of fear was identified by all participants; however, the impact of fear on losing confidence and also regaining confidence varied between participants. The first fear that participants described was the fear of having another stroke:

. . . Every time I had a headache, I feel lightheaded, my leg hurts, there is always that question, erm, maybe [laughs], just kinda maybe.

Mick 13.2

. . . you never know what is going to happen tomorrow.

June 17.6

. . . I am going to have another stroke? – So that was on my mind.

Ted 12.1

. . . alert to any changes in my body at all, you know? Anything, because I think now, perhaps this is going to be the big one, you know.

Barbara 19.4

Participants described living with this fear and how it prevented them from participating in everyday activities. Mick experienced a second stroke, and articulates this period, as:

cementing the fear in my brain

Mick 12.14.

This second event had a huge impact on his recovery and confidence to leave the house, and resulted in a period of avoiding going out. For Mick, confidence has been about gradually overcoming this fear to enable him to regain confidence, to enable him to engage in what he chooses. He describes this process as gradual, and experiences ‘good and bad days’, suggesting confidence has a temporal component. Similar meanings evolved from June, indicating that fear is a factor that underpins her participation in going out of her home environment. Ted’s fear of having another stroke directly impacted on feeling anxious in crowds, and cites shopping centres as a place that held a particular anxiety. Avoidance was his coping strategy.

Fear of going out/social confidence

Fear of going out and being socially active after a stroke was a major concern voiced throughout the interviews by all of the 10 participants. Some were able to address their fears early on in their recovery, whereas others found it more difficult and, years after recovery, have not fully been able to achieve this, resulting in an avoidance of going out and a general sense of a diminished social lifestyle and social confidence.

I don’t know whether it was that I was self-conscious about the fact that I was struggling with my wheelchair, or struggling to walk, people looking at me or not, but . . .

Ryan 15.13

Eventually, as your confidence grows, your bubble starts to get bigger, erm, the garden, then the street, then the shops, eventually.

Mick 19.2

Participants also attributed positive encouragement from others as an enabler to going out and not avoiding activities that caused fear.

Although participants acknowledged huge fears about going out and social interactions with others, coupled with this fear was an immense desire to overcome these fears. For example, Ryan states ‘I had coping strategies pinned all over the wall’ (15.17). It is clear from the descriptions evolving from participants that confidence improves over time. Nevertheless, for some this is a slow process that may never be fully resolved. In summary, fear has a huge impact on daily activities and lives after stroke, often linked with low self-efficacy and avoidance of engagement in tasks, roles and events.

Team confidence/collective efficacy

The influence of significant others, as touched on within the previous theme, impact on levels of confidence. Although, not surprisingly, participants described positive influences as enablers to regaining confidence and conversely, negative influences act as barriers, the negatives and positives are not always overt in the context of participant’s daily lives and often require a period of reflection. Influence from a supportive friend, coupled with self-determination, one participant’s confidence levels increased to a point that enabled her to pursue ambitions she would not have considered prior to her stroke:

He [Friend] said ‘Let’s go to Cyprus.’ I said I’m not going to CYPRUS [increased tone: laughter] – you see I’ve never flown before, you see, so we flew to Cyprus.’ [laughter]

Freya 41.7

Conversely, another participant describes her family’s ‘help’ as being restrictive:

They don’t let me, well, I can’t go out of the back door without someone going with me.

Helen 11.13

Independently mobile and competent, this participant describes feelings of inadequate opportunities, to fulfil her potential. A message underpinning success for another participant, fundamental in gaining the confidence to mobilise outside after stroke, was a physiotherapy intervention:

. . . the best thing that happened to me, and the most erm, useful one to me, was being referred to a physiotherapist.

Barbara 11.1

Initially, unable to mobilise to the kerb without fear of falling, and apprehensive about physiotherapy intervention, she described factors such as humour, empathy, positive reinforcement and encouragement as the components that led to a positive treatment outcome. Keen to feedback her perceived success, once her treatment was completed, she describes telephoning the physiotherapist who delivered her treatment:

And I said to him, I can walk into town now, I can walk as far as Marks and Spencer’s, and he said ‘I can’t believe it, that’s wonderful.’ But I can, and I can now get as far as the shopping centre.

Barbara 24.19

Increased confidence after stroke appears to have a component that is influenced by the actions of others, in addition to the actions of self.

Role confidence

Participants perceived that ‘loss of roles’ had an impact on decreased confidence.

Loss of a driving role was considered hugely important to two participants and both these participants reported being more confident and active once they were able to resume their driving role. A gardening role, for another participant, despite a memory issue since stroke, still enables her to participate in an enjoyable role:

Couldn’t remember when they were supposed to flower, if they flowered and all those kind of things, but it didn’t bother me.

June 26.38

Confidence in meaningful roles appeared to make a difference to all participants. Increased confidence was evident when participants were motivated to engage in similar roles that were important pre-stroke or when they had found replacement roles that generated similar benefits.

‘It’s not I can’t, it’s I can’: skill mastery

Participants illustrated many examples of how relearning skills and becoming successful in mastering a new skill as being one of the biggest factors in regaining confidence. Some participants were slow to start to regain skills and gave examples of how they avoided activities that evoked fear and uncertainly. Others described being successful in a particular task or skill, which enabled them to believe they could increase their range of activities. This correlates closely to the self-efficacy theory. Participants who described themselves as confident pre-stroke tended to also describe a higher level of self-efficacy. This process is best described by participants:

Once I could get up and take a step, I knew I could do it, I know it seems daft.

Ryan 10.13

Gradually your confidence builds. The first time is always kinda nervous [pause] well it is for me now anyway.

Mick 31.4

Eventually, started cooking for myself, I thought, oh I can manage to do different things instead of using the microwave all the time.

Freya 30.2

Once participants began to succeed and achieve by repetitive practice, their motivation and confidence levels improved enabling them to move on to other activities. Practising skills was described as increasing competence and confidence; nonetheless, when practice did not improve skill, participants described becoming frustrated and found that their confidence decreased.

‘Inner strength’ and confidence

The final theme examines how the phenomenon of confidence is associated with other components of psychological distress. For three participants, episodes of depression were prevalent after stroke. Other participants identified periods of low mood, and most had some experience of anxiety. Low confidence was cited as underpinning their daily lives throughout these experiences. One participant stated being depressed ‘makes you feel a bit useless’ (Helen 23.7) and another describes similar sentiments: ‘Some days I feel helpless, alone’ (Mick 20.10). Interestingly, a participant describing herself as having very low self-esteem and a history of depression prior to her stroke, perceives she has a raised self-esteem and higher self-efficacy beliefs as a result of her stroke journey – ‘an inner strength almost that I didn’t realise I had’ (Freya 35.19). She illustrates this by telling us:

. . . the main barrier is within yourself, I think. The biggest one is within yourself, you think I can’t do that and you think about it and you think I’ll try. But you don’t try very hard because you think you can’t do it, you see? So you have to try a bit harder and then you realise you can do it, you know. So often the biggest barrier is within yourself.

Freya 50.11

Although focusing on doing and achieving, a process that increased self-efficacy beliefs was experienced by some participants; others clearly described it being a struggle to achieve the same:

I know in the back of my head there was something telling me you had to try and do these things, because, if you don’t June, you’ll just sit and vegetate, and life is too important for that.

June 23.17

As soon as I see a crowd of people I start to lose my balance. Go ‘hold me’ someone hold me [panic in tone of voice].

Alison 15.1

This latter quote suggests that success is about more than skill and ability. Alison was able to illustrate how negative thinking can often lead to an unsuccessful outcome.

Reinforcement from others suggests that another participant is not enough on its own: ‘Everybody kept saying “Oh, you are doing so well” but it wasn’t enough for me’ (Helen 8.2), suggesting that positive reinforcement does not compensate for intrinsic worth. The data signify that participants’ confidence levels have been affected by having a stroke to varying degrees. In seeking to explore the meaning of confidence after stroke, connections and interrelations between themes were identified, and similarities and differences in the data and between participants were disentangled, confirming that the phenomenon of confidence is multifaceted and complex.

Summary

• Loss of confidence after stroke is a common experience.

• The impact of stroke is truly realised only when a stroke survivor begins to establish routines, and continues with his/her life. Loss of former roles and a lack of competence when trying to engage in previously familiar tasks is prevalent in the early stages of stroke recovery, often linked to questioning self-identity.

• Gradually regaining skills and re-establishing identity appeared to increase confidence over time.

• Fear was identified in this study as a huge barrier to being confident to do the things participants wanted or needed to do.

• Avoidance behaviours were evident and described in the data, lowering participant’s self-efficacy beliefs, further limiting the opportunity to become more competent and confident in activities and tasks.

• Social confidence, fear of social interactions and stigma, was also embedded within the study’s findings. Gracey et al. 67 argued, if these issues fail to be resolved, a poor psychosocial outcome long term after stroke is realised.

• Strategies that enable stroke survivors to resolve loss of confidence in social situations should be considered a necessary treatment component in stroke rehabilitation.

• Confidence in ‘team’ and/or ‘partner’ was evident in the data. Descriptions of encouragement, patience and positive reinforcement are examples of factors that helped improve confidence and self-efficacy beliefs.

• Prevention of opportunities for independence and choice of activities resulted in loss of confidence, control and disengagement during recovery.

• A model to increase confidence in sport, which uses a multivaried framework encompassing self-confidence, role confidence, partner confidence, cohort confidence, team confidence, coach confidence and organisational confidence68 might be suitable for stroke patients when trying to improve outdoor mobility.

• Highlighted in the literature is the concept that physical appearance often impacts on self-confidence; this was not prevalent in these study findings.

Key findings

Stroke patients can become housebound, miserable and in poorer health because they cannot participate in outdoor mobility. 14 This report presents the findings of a multicentre RCT to evaluate an outdoor mobility rehabilitation intervention for people with stroke. The intervention under evaluation was a complex mix of goal setting, practising outdoor mobility (which included walking outside), psychological support, and provision of information and self-monitoring of outdoor mobility through daily travel calendars. These calendars were used as an outcome measure. It was delivered by NHS therapists based in the primary care setting. The aim of the study was to replicate a single-centre study that found significant improvements in outdoor mobility participation when stroke patients were given the intervention by one highly skilled therapist. It aimed to evaluate whether the results were generalisable to NHS therapists in different UK locations. In addition, health-related quality of life and cost-effectiveness were measured.

The multicentre study replicated the methodology used in the single-site study. It reached its recruitment target on time. There was a high rate of follow-up at both the 6-month follow-up (to measure for an immediate effect of the intervention) and the 12-month follow-up (to assess whether it had a longer-lasting effect), and 70% of all travel diaries were returned. Stroke survivors and therapists were keen to take part in the study and although no formal qualitative study was completed to assess processes, it would appear from the proportion of patients who completed the travel diaries that getting out of the house is a major issue, even many years after stroke. A total of 568 participants from 15 UK-based sites were recruited over 18 months. The intervention was delivered, according to the protocol, to 287 participants, by 29 therapists, and was similar to that delivered in the single-centre study. Outcomes were collected by postal questionnaire and participants were supported, if needed, in their completion by RAs blind to allocation. The results were analysed using an intention-to-treat analysis, with the effect of different therapists at different sites being taken into consideration. A small qualitative study explored how a reduction in confidence might have affected people in the intervention group. The primary outcome measure used to calculate the sample size was health-related quality of life, as assessed by the Social Function domain of the SF-36v2. In addition, outcome measures used in the single-centre study – SWOM, travel journeys, activities of daily living ability and psychological well-being – were completed. A full economic evaluation was undertaken. This chapter will discuss the intervention, results, strengths and limitations of the study.

Intervention delivery

The intervention in this trial was developed over a number of years (2000–8), a treatment manual was produced and the CI taught therapists how to deliver it by a 2-hour training session. The intervention was a mixture of physical, psychological and planned preparation to achieve getting out of the house. Therapists were instructed to provide treatments as needed up to a maximum of 12 sessions over a 4-month period. They reviewed and planned their treatments following local protocols.

We consider that the intervention was delivered as per protocol to the majority of participants. We make this assertion because the intervention was delivered by occupational therapists and physiotherapists or by supervised rehabilitation assistants 100% of the time. These therapists had been trained to use the outdoor mobility manual by the study CI. It may have been that the manual was too prescriptive and did not allow therapists the possibility of providing more treatment sessions, but, owing to research methodology and financial restraints, therapists had to stop treatment after 12 sessions. The fidelity of treatment checking recorded that 100% of sample indicated that the therapists were delivering the correct treatment. We have to acknowledge that the fidelity of treatment checklist was not a standardised assessment owing to a lack of published measurements and that the last question which gave us this 100% rate had not undergone psychometric testing. The participants received a median of seven rehabilitation sessions with a duration of 3.5 hours. This is similar to that delivered in the single-centre study (six sessions, duration 4 hours). However, when the range of the intervention sessions was explored, it was found that approximately equal numbers (20 had one session, 20 had two sessions . . . , 20 had 11 sessions) but 60 participants received 12 sessions. It would appear that some patients may have needed > 12 sessions to achieve their goal. This could be the reason that nearly one-third did not complete their rehabilitation to the satisfaction of the therapist. Studies of upper limb rehabilitation suggest that > 3 hours per day for 30 days is needed to measure an improvement. 69

Although the number of intervention sessions was restricted to replicate what might be provided by the NHS, the content of the intervention had been developed to be person centred and therapists could be flexible in how it was delivered. Therapists who provided the intervention and participants provided informal feedback and said they felt it was an appropriate and clinically relevant treatment technique. The research team have received over 50 requests for the intervention manual and training over the last 3 years. This indicates a real need for an evidence-based outdoor mobility programme. A more recent study developed a person-centred rehabilitation intervention by asking 132 participants to prioritise their main goals. The goals stated were mainly related to active recreation, household and community management, mobility and socialisation, information on stroke and prevention of new strokes, outdoor mobility and transportation. 70

Effect of the intervention on health-related quality of life

The primary outcome measure of health-related quality of life found no significant differences between the control and intervention group at either the short- or long-term follow-up. The Social Function domain of the SF-36v2 was used to assess health-related quality of life in this population because the SF-36v2, as a whole, has been subjected to psychometric testing, used in numerous descriptive and intervention studies, and can be completed in < 10 minutes by self, proxy, interviewer or telephone. 71 This allows comparisons to be made with other health-care treatments. It includes a range of domains, such as loss of role, participation away from the home and social inclusion, which are areas that therapists hope to improve through the type of rehabilitation under evaluation. The Social Function domain of the SF-36v2 consists of two questions and was completed by most (500) participants out of the original sample (568 participants). The two questions were:

1. During the past 4 weeks, to what extent has your physical health or emotional problems interfered with your normal social activities with family, friends, neighbours or groups?

   1. (Please tick one.) Not at all/Slightly/Moderately/Quite a bit/Extremely

2. During the past 4 weeks how much of the time have your physical health or emotional problems interfered with your social activities (like visiting friends, relatives, etc.)?

   1. (Please tick one.) All of the time/Most of the time/Some of the time/A little of the time/None of the time

This measure was not used in the single-centre study and other trials of rehabilitation using this type of measure have found similar neutral findings. 72 ^– 74

Therapists and participants were concerned about the use of this measure, as they felt that the intervention aimed to improve outdoor mobility participation and the expectation that it would impact on social participation was overambitious, especially as the intervention was limited to 12 sessions over 4 months. In addition, they stated that participants wanted to undertake mobility activities for a number of reasons: getting to the doctors, dentists, shopping and work, which might not be classified as an improvement in quality of life as measured by these two questions. Improvement in outdoor mobility therefore might not have an impact on health-related quality of life as measured or it might take longer for the benefits to be realised. We conclude that the results were reliably collected and that the outdoor mobility intervention delivered in this study did not effectively improve stroke patient’s quality of life as measured by the Social Function domain of the SF-36v2. We suggest, however, that this is not a reason to stop outdoor mobility rehabilitation beginning offered to stroke patients. We believe that this targeted intervention has potential to increase outdoor mobility participation, which we consider an important part of activities of daily living. In addition, we have to consider whether the control group received a treatment that may have a role to play with patients for whom there have been many years since their stroke. We present our reasoning below.

Effect of the intervention on outdoor mobility participation

The main finding of the single-site study24 was that the intervention group were significantly more likely to participate in outdoor mobility. This positive outcome was considered an important clinical benefit. Stroke patients have complained about becoming housebound, isolated and miserable. This single-centre study demonstrated that, with a relatively short period of rehabilitation, patients could be taught how to increase their outdoor mobility. This included walking, using buses and electric pavement scooters. The outcome was assessed using two measures: SWOM participation and number of journeys. In the multicentre study, the intervention participants were no more satisfied with their outdoor mobility participation than the control participants at both 6 and 12 months but they were more likely to make journeys than those participants in the control group. However, this difference in number of journeys was apparent only when the data were adjusted to take the therapist effect into consideration. It appears that some therapists are able to produce these significant results, whereas others are not. We do not know whether it was the way the intervention was delivered, the characteristics of the participant or the skills of the therapist that produced this significant result. This outcome was measured using participant-reported journeys, which included outdoor walking, by travel diaries collected each month by post. Participants were taught how to use the calendars at the baseline visit by the RA and were encouraged to send them back using pre-paid envelopes. We feel that this was an objective measure as participants had to record each time they left the house and went somewhere. All participants completed the diaries and, as 70% of all travel diaries were returned, we feel this is a reliable outcome.

The results replicate those found in the single-site study, for which intervention participants took significantly more journeys at both 4 and 10 months. We need further research to explore the therapist and site effects in more detail. We consider that an increase in the number of outdoor journeys is an outcome that patients and health-care providers will feel is worthy of investment. It may be that an increase in outdoor mobility is helping people get to the doctors or health centre, they maybe going to work, or helping family with childcare. We know that people wish to get out of the house ‘just for the sake of it’ or ‘to get fresh air’ or to ‘enjoy just moving around’. 23 In addition, there is evidence from a systematic review of exercise after stroke, which found improvements in health-related quality of life in the short term. 75 It is possible that the outdoor mobility intervention provided in our study, which was mostly mobility training with the aim of walking > 100 m, was providing an exercise programme.

Satisfaction with outdoor mobility was measured using a single question: ‘Do you get out of the house as much as you would like?’ Although this measure was not designed as a patient-reported outcome measure (PROM) to assess health-related quality of life, it has many of the elements. It measures how people perceive the impact of a health intervention, is pertinent to the intervention being delivered and is easy to complete. Prior to this multicentre study, the measure had been subjected to some reliability testing76 and we have no reason to believe that the participants in the multicentre study found the question ambiguous. When we compared the groups we found no significant difference in outcome for this measure.

Effect of the control on outdoor mobility

There was very strong evidence that the control group improved markedly over time. At baseline, 259 out of 281 (92.2%) participants were dissatisfied with outdoor mobility but at the 6-month assessment this had reduced to 78% (160/205), a 15% reduction. The corresponding reduction in the intervention group was slightly greater (18%) with 268 out of 287 (93.4%) expressing dissatisfaction with outdoor mobility at baseline and 171 out of 227 (75.5%) expressing this at the 6-month assessment.

Participants in the control group must have been provided with a treatment that affected a change. It would be expected that people 3.5 years after stroke would remain stable over the next 6 months. This was a pragmatic trial and the therapists were told to deliver the baseline control as they would in the NHS. This was to replicate that given in the single-centre study. However, the combination of a face-to-face baseline visit presenting tailored (and participant focused) local transport and mobility information and use of daily travel diaries led to an effect in both the control and intervention groups. The baseline visit included a discussion about potential goals, which could have focused the participant’s thoughts towards improving outdoor mobility. We state previously that passive provision of leaflets and information is ineffective. However, we feel, with the motivated people who took part, that the control (targeted provision of leaflets and information) has acted in a different way. In addition, it is established that providing patients with daily diaries (e.g. food diaries) can lead to behavioural changes and an effect on the outcome being recorded. They provide a reference point for reflection on past and current behaviours, and they allow people to track changes over time and bring their behaviour to the front of their mind. In essence, they are a self-monitoring tool. Diaries have been used in behaviour modification programmes for a range of problems from weight loss and exercise programmes through to managing incontinence, tinnitus and migraines/headaches. Greenhalgh77 who investigated the feasibility of using diaries to measure the daily impact of multiple sclerosis on participants found that by completing a dairy participants became more aware of their symptoms, and this resulted in increased reporting. This impact may be further improved by the participants being aware that each month we would request the information they had recorded.

Effect of the outcome on functional ability and psychological distress

The intervention did not lead to greater levels of activity or reduce participant or carer psychological distress. The assessments used to collect the outcomes were well known and standardised measures used in many stroke studies. 78 ^– 81 We have to conclude that the intervention, as delivered, does not impact on these areas. This result is in line with previous studies, which has found that a targeted rehabilitation intervention delivered over approximately six sessions can improve the specific domain being addressed but does not affect other domains. 82

Was the intervention cost-effective?

In the base-case analysis the mean incremental cost (total NHS and PSS cost) was estimated to be £3413.75 (95% CI –£448.43 to £7121.00) with an incremental QALY gain of –0.027 (95% CI –0.060 to 0.007). This would suggest that the intervention was dominated compared with the control. The sensitivity analyses were broadly in line with the results of the base case.

Effect of the intervention on falls

Falls occurred in all age groups of stroke patients, with a median of three falls per year compared with one in four people from an aged-matched, non-stroke population falling each year. 83 It may be that we need to explore specific falls-prevention interventions for people with stroke. There were no differences in falls between the intervention group and the control group, providing evidence that the intervention did not cause people to fall over more often.

What did we learn about confidence after stroke?

Strongly emerging themes indicated that barriers to high levels of confidence included loss of former self, negative reinforcement from others including health professionals, loss of confidence in roles and fear of everyday activities. Confidence levels were found to change over time, with participants having ‘good and bad days’, but, generally, the participants spoke of improved confidence as time since stroke increased. The factors that helped stroke patients regain their confidence were positive reinforcement from others, successful skill mastery and self-defined positive changes in roles. The study demonstrated that stroke survivors in this study were experts of the confidence phenomenon by identifying a variety of factors that have both enabled them to achieve and succeed, resulting in increased confidence levels, and also identifying barriers that prevent them from regaining confidence. These findings suggest there is a need for therapists to understand the impact that low confidence might have on outdoor mobility and to aim to provide interventions to overcome this barrier.

Adverse events

We had a small number of adverse events [20 from 17 (17/287; 5.9%) participants] within the intervention group during the delivery of the intervention. There was no evidence to suggest that the intervention led to an increase in falls that required the assistance of a health-care professional.

Methodological issues

What the study found

This study provides robust evidence that getting out of the house is a real and substantive limitation among stroke survivors even after many years. It demonstrates that rehabilitation interventions that aim to improve outdoor mobility are appropriate for delivery by NHS therapists and, therefore, the results provide definitive and generalisable answers to clinically important questions.

The intervention has the potential to increase outdoor mobility participation in stroke patients as measured by journeys and SWOM but it has to be delivered in a specified way. In the single-centre study that found similar results, the patients were treated by the same therapist who was experienced and skilled in stroke care. This multicentre study has highlighted the issues of implementing an intervention that was developed for a single-centre study across the NHS.

The intervention had no measureable effect on quality of life (social function), activities of daily living or mood so we cannot recommend that this intervention is used to improve limitations in these areas.

Unfortunately, a major limitation of this study is that control participants who were expected to remain stable over the period of the study improved in their SWOM over the first 6 months. We suggest that the information and verbal advice plus monthly travel diaries may have acted as a treatment that may have affected the results of the primary analysis. The intervention was more costly than the control and did not improve quality of life compared with control.

Implications for clinical practice

This study replicated the results found in the single-centre study. An outdoor mobility intervention can increase outdoor mobility participation but this change does not appear to have a significant effect on quality of life (social function) compared with a control. So is this increase in journeys a clinically relevant finding that NHS commissioners will be paying for?

To implement this intervention into clinical care, it would appear from the single-centre study that the intervention needs to be provided by one experienced and stroke-trained therapist, who would provide all of the intervention sessions therefore becoming an expert in outdoor mobility.

To implement the control, outdoor mobility information and verbal advice needs to be personalised and provided face to face by an expert in community services. This needs to be supported by a self-reporting process that allows patients to let the therapists know how they are progressing.

Recommendations for research

1. Further research is needed to find new and innovative techniques and interventions that might help stroke patients get out of their houses as much as they would like. The results of our multicentre study indicated that we should be looking at the control, where we targeted the motivated participants, gave people decent information, and provided a structured behavioural change programme that included charting the behaviour changes.

2. Research is needed to explore alternative outcome measures that are clinically relevant but that can be used to compare health-care techniques. In this multicentre study we used a health-related quality of life (social function) measure but the intervention was targeted at outdoor mobility participation. Stroke patient’s value increased outdoor mobility in its own right. Further qualitative research is needed to explore how increased journeys may impact on quality of life.

3. We recommend that research is completed to explore the divergence in results between single-site and multisite studies. This successfully completed multicentre trial followed from a positive single-centre study. However, the results were different. We considered that we had replicated the methodology used in the single-centre study as far as possible when completing a pragmatic study, but we realise that this was a complex intervention delivered in a complex way to complex patients.

4. Research is needed to develop stroke-specific falls prevention interventions and psychological interventions to improve confidence. In this study falls occurred in all age groups of stroke patients and more often than in an age-matched group without stroke. Fear of falling and reduced confidence have been shown to reduce outdoor mobility.

5. Data from this study need to be shared with other research groups to allow discussion and comparison of multiple modelling analysis.

Contributions of authors

Philippa A Logan conceived the study, was the grant holder and CI for the study, and wrote this summary and the original protocol.

Mat P Leighton, based in the NCTU, was responsible for day-to-day running of the trial and data collection/management, and was responsible for most revisions of the protocol, incorporating suggestions and comments from Philippa A Logan, Marion F Walker, John RF Gladman, Tony J Avery, Hywel C Williams, Ossie Newell, Sarah Armstrong, Tracey H Sach, Kathleen O’Neil and Garry R Barton.

Marion F Walker, John RF Gladman, Tony J Avery, Hywel C Williams, Ossie Newell, Sarah Armstrong, Tracey H Sach, Kathleen O’Neil, Simon Leach, David Barer, Jane Horne, Janet Darby, Garry R Barton and Nadina B Lincoln have contributed to the writing of this summary and helped to write the original full protocol.

Hywel C Williams, when director of the NCTU, helped to design the study and secure funding.

In addition, Sarah Armstrong was the study statistician and has particular responsibility for the analysis. Samir Mehta and Lisa J Woodhouse were study statisticians and analysed the data.

In addition, Tracey H Sach and Garry R Barton were the study health economists and were responsible for economic analysis.

All authors have read and approved the final manuscript.

Disclaimers

This report presents independent research funded by the National Institute for Health Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, NETSCC, the HTA programme or the Department of Health. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, NETSCC, the HTA programme or the Department of Health.

Publication

Logan P, Leighton M, Walker M, Armstrong S, Gladman J, Sach T, et al. A multi-centre randomized controlled trial of rehabilitation aimed at improving outdoor mobility for people after stroke: study protocol for a randomized controlled trial. Trials 2012;13:86.

TOMAS

Getting out of the House Study

Statistical analysis plan

Abbreviations

1. INTRODUCTION AND PURPOSE

This document details the rules proposed and the presentation that will be followed, as closely as possible, when analysing and reporting the main trial results.

2. SYNOPSIS OF STUDY DESIGN AND PROCEDURES

3. GENERAL ANALYSIS CONSIDERATIONS

4. DESCRIPTION OF SUBJECT CHARACTERISTICS

4.1. Disposition

A flow of patients through the trial will be summarised in a CONSORT diagram that will include the eligibility, reasons for exclusion, numbers randomised to the two treatment groups, losses to follow-up and the numbers analysed.

5. ASSESSMENT OF STUDY QUALITY

6. ANALYSIS OF EFFICACY

7. HEALTH ECONOMIC DATA ANALYSIS

This analysis will be conducted separately by a Health Economist. This evaluation aims to estimate the incremental cost effectiveness of an outdoor mobility rehabilitation intervention, compared with usual care, from a health and personal social services perspective. In addition the patient and carer perspective will be examined separately.

Any censored data will be adjusted for, using appropriate published techniques. If non-dominance occurs, an incremental cost effectiveness ratio will be produced. The confidence region around the ratio will be estimated using appropriate statistical techniques such as the non-parametric bootstrap method. This stochastic analysis will enable a cost effectiveness acceptability curve to be produced illustrating the uncertainty surrounding the optimal decision.

Probabilistic sensitivity analysis will be undertaken to test the robustness of the results. Estimates of the incremental cost, incremental cost effectiveness and the uncertainty around these estimates will enable us to discover whether ‘The getting out of the house intervention’ offers value for money.

8. QUALITATIVE DATA ANALYSIS

Data from the semi-structured interviews to assess the participants’ confidence after their stroke will be analysed by a qualitative researcher. Data will be analysed using Interpretive Phenomenology Analysis (IPA) principle using a six stage framework (89). The aim is to identify enablers and barriers to regaining confidence from the patient perspective.

9. ANALYSIS OF EFFICACY

Fidelity of treatment will be assessed by reviewing the notes of therapists against a predefined checklist to determine whether the intervention was being delivered according to the protocol. Furthermore, a selection of therapy visits will be observed and scored against a predefined checklist.

10. ANALYSIS OF SAFETY

11. FINAL REPORT TABLES AND FIGURES

12. APPENDICES

Instructions in MLwiN

1. Open the saved file in MLwiN

2. Select model and equations and the equations window should appear

3. In the equations window at the bottom, select notation and unselect the multiple subscript option, and click done

4. Now click on the ‘Y’ in the equations window and select the SFscore from the list

5. Select the 3 levels from the N-Levels options

6. Then select level 3 to be siteid, level 2 to be therapist1 and level 1 to be refno

7. Now select ‘B0’ from the equations window and choose it to be the constant vector of 1’s and select this to be random at level 3, level 2 and level 1.

8. Now click on ‘Add term’ option at the bottom of the equations window and select the covariates described for the primary analysis (Note: none of these should be selected as a random effect)

9. Once all the terms are added, make sure that the estimation procedure is on the option ‘IGLS’ and click on start

10. Then change the estimation procedure to MCMC and run the model once more

11. Once the model is run using MCMC, click on Model/MCMC/Classification from the menu bar

12. Select the option for multiple classification Level 2 option and in the option for number of columns enter the number of columns there are for the therapists

13. Then click on the drop down menu for Weight start column and click on the variable from where the weight for the first therapist is

14. Then click on start and run the model for the final time and the results will be the final results to be used for the analysis

All other secondary analyses will be done in the same manner as the primary endpoint.

13. References

Introduction

An Outdoor Mobility Rehabilitation Training Manual was produced for therapists to provide a guide on an outdoor mobility intervention to be offered to stroke patients. As this was a large multicentre trial, this manual served as an important guide to ensure that therapists followed a similar treatment programme across sites. The intervention outlined in the manual was based on knowledge gained during an earlier single-centre study. In this study the intervention was found to have made a massive difference to people’s lives by helping them out of the house more often. The manual is split into different sections and each section is summarised below.

Background

Background information on the prevalence of stroke, and the effect of strokes upon the lives of people with stroke, is provided in this section. Research data are provided to support the figures presented. The section moves on to provide the rationale behind providing an outdoor mobility training intervention for people with stroke. Research is cited to support the need for such an intervention study.

It is outlined in this section that the multicentre trial, to which the manual relates, follows on from a single-centre study that found clear benefits with the intervention. However, the generalisability of this study was limited as the intervention was delivered by a single therapist, in one city, and there was no health-economic evaluation. It is argued that a multicentre trial is now needed to determine whether the intervention is effective and cost-effective before it can be recommended for wider adoption across the NHS.

Models and approaches to rehabilitation

In everyday practice, therapists use a combination of physical and psychological models and approaches when devising treatment programmes for stroke patients. These models and approaches provide a theoretical base for the intervention. Therapists will often use a combination of models and approaches when deciding on a treatment programme. Although there have been papers published describing the models there is very little research to evaluate or compare the models. There is no strong evidence to suggest that one model or approach is superior to another. The manual therefore lists and describes models and approaches that therapists may choose to use in their treatment sessions. These may be used together with the practice of outdoor mobility activities. The models described include the Compensatory or Functional model, the Model of Human Occupation, the Cognitive Frame of Reference, and the Adaptive Skill model. The neurodevelopmental approach is also described, along with the main techniques used by therapists, including the Bobath, Rood, Conductive Education, Proprioceptive Neuromuscular Facilitation and Sensory Integration techniques. It is stressed in the manual that this is not a comprehensive list and other models and approaches can be adopted.

Benefits and barriers to going outside

This section looks at why people wish to get out of their home and the barriers preventing this. It includes two checklists. The first checklist provides a list of possible destinations. This serves as an aid to prompt patients to identify outings of personal interest to them. The second checklist provides a list of possible factors that may hinder trips out of the home for the patient. These issues can then be discussed and addressed by the therapist and patient.

Assessing for limitations

This section provides a screening form to be completed with the patient to help the therapist and patient to plan the outdoor intervention. The form includes 11 screening questions on transport options and outdoor mobility. The form is completed during the treatment planning stage of the intervention. The form can also be used at intervals during therapy if progress seems slow.

Building a useful address and information resource

This section provides a template for the therapist/other team members/patient to insert useful contact details of local transport and community services. Examples include the Blue Badge Scheme for car parking, Dial-a-Ride, voluntary car schemes, Shopmobility and the local Disability Living Centre contact numbers.

Goal planning and activity analysis

The importance of goal setting is emphasised in this section. Several activities are broken down into smaller more detailed goals as examples of possible outdoor goals that could be completed with patients. The activities include walking outside, driving a car, using the bus and train, using Dial-a-Ride, the voluntary driver scheme and electric pavement scooters.

Pre-outing checklist

In this section a checklist is provided to help the therapist and patient to identify any potential risks, hazards or challenges that might arise during community outings. This checklist is completed prior to the first outing. It ensures that factors are considered which will help to make the trip both safe and more successful. The checklist includes mobility, upper limb function, cognitive and perceptual function, vision and continence. Each area is broken down into skills and abilities that need consideration.

It is recommended in the manual that the therapist observes performance around the home before venturing outside.

Protocol for the first outing

This section prompts the therapist to assess and plan ahead for all contingencies prior to the first outing. Examples of early outings recommended in the manual are walking to the garden gate, walking to the street corner, walking to the closest bus stop or a walk around the block. A checklist is provided of considerations and contingencies for this first outing, along with consideration of activities that can be practised first in the home environment.

Protocol for outdoor walking

In the single-site outdoor mobility study, walking outdoors was found to be an important goal for patients. Of the 78 main goals recorded, 22% focused on walking outdoors. In the protocol it is recommended that this activity starts with simple and small goals, such as walking to the garden gate, and progresses once skills are consolidated to encompass more demanding situations. The protocol stipulates setting practice targets between sessions aimed at increasing confidence and fitness, and includes activities such as daily trips to the street corner with a family member.

The protocol for walking is broken down into three levels. The first level incorporates walking over a short distance in a quiet environment, requiring minimal attention and physical demands. The second level progresses to incorporate more moderate demands involving road crossings, kerbs and gradients. The final level requires multitasking activities, such as carrying a bag, handling money while standing, and walking in a busy location.

Protocol for using the bus

In the single-site outdoor mobility study, catching the bus was the second most popular goal. Of the 78 main goals recorded, 17% focused on taking a bus. It is recognised in this protocol that not all therapists themselves may be familiar with using public transport. To this end guidance is provided on the steps and skills to consider for this activity, including recognising and hailing the correct bus, managing money and ticketing, boarding and disembarking the bus, and recognising the correct destination.

Once again the protocol is broken down into three levels. The first level involves home practice of reading timetables, handling money, and preparing contingency plans. The second level moves on to supervised outings. Maximum prompting and close supervision is provided at this level. The final level progresses to just standby or distant supervision.

Protocol for using the train

As with the bus protocol it is recognised in this section that not all therapists will be familiar with using trains. Equally people with stroke may not be familiar with this mode of transport, particularly if they drove before their stroke. To this end guidance is provided on the steps and skills to consider for this activity, including reading the indicator board, purchasing a ticket, accessing the platform, identifying the correct train, negotiating crowds, and boarding and leaving the train.

Similar to the bus protocol the train protocol is broken down into three levels. The first level involves home practice of reading timetables, managing money and preparing contingency plans. The second level progresses to supervised outings with close supervision and maximum prompting. The final level involves just standby or distant supervision.

Protocol for using outdoor pavement scooters

In the single-site outdoor mobility study, being able to use a (personally owned) motorised scooter was a primary goal for six people with stroke, although using a scooter on a temporary loan for shopping around town (part of the Shopmobility service in England) was a primary goal for another six people with stroke.

The protocol for using an outdoor pavement scooter is broken down in the manual into two levels. The first level involves a trial off road. This enables practice operating the scooter controls and familiarisation with charging the scooter battery. The second level progresses to a trial on the road. Practice progresses from quiet to busy roads, crossing at traffic lights, negotiating kerbs, slopes, gradients, obstacles and pedestrians, and parking the scooter outside shops and home beside the battery-charging location.

Once again, the protocol includes a checklist of the skills and competencies needed to safely drive an outdoor pavement scooter.

Each level of the protocol for outdoor walking, using the bus, using the train and using outdoor pavement scooters is clearly stipulated so that therapists across sites follow similar treatment programmes for each activity. Family members are encouraged to assist in the practice of skills and, importantly, the protocols advocate the setting of practice targets between sessions to assist in the consolidation of skills.

Intervention record form

This section provides the therapist intervention paperwork for the study, which includes:

• A form requiring the therapist to break down the components of each intervention into minutes. The therapist records the time spent on mobility task training, other rehabilitation training, adaptive equipment, referral to other agencies, information provision, confidence and motivation, and goal-setting activities.

• A form to record the patient’s goals and their relevant medical history.

• A form to record the running records of each session completed.

Case vignette of treatment plans

A case vignette taken from rehabilitation notes is provided as a guide for therapists in this section when planning treatment sessions. This vignette outlines a clinical history of a person with stroke. Information is provided on their ability and skills around personal and domestic activities of daily living, their transfer ability and their level of mobility. The vignette incorporates their social situation and outlines their local environment, including access to their home property. The vignette moves on to focus on the person’s experience of using different modes of transport, and then highlights the goals set with this person. This is followed by a detailed breakdown of the six treatment sessions completed.

Confidence and motivation

As self-confidence to complete a task and the motivation to persevere are such important aspects of the outdoor mobility intervention, this section of the manual is dedicated to explaining the significance of these two attributes.

Self-confidence in relation to the study is about having the confidence to complete outdoor mobility. This not only relates to confidence in self, but also to having confidence and trust in others, such as the therapist. This is particularly important when therapists are encouraging people with stroke to try new activities or to push themselves harder.

Motivation is the activation or energisation of goal-orientated behaviour. It requires that those enrolled on the study have some desire to undertake outdoor mobility. Individuals need to be able to identify meaningful reasons why they wish to attain goals in order to have the motivation to succeed.

Sample letter for requesting help with purchasing equipment

In this section a sample letter is inserted to provide therapists with guidance when seeking to apply for funding for outdoor mobility equipment for their patients. In the UK, motorised scooters are not generally available via government schemes. Individuals therefore have to purchase their own scooter, and may seek financial assistance from philanthropic agencies, local church groups or service clubs. In these situations therapists may wish to support their applications by writing a letter, as per the sample provided.

References

This section of the training manual provides the full references that have been quoted in the main body of the manual.

PowerPoint slides

The PowerPoint (2007) slides (Microsoft Corporation, Redmond, WA, USA) presented during the therapist training days are provided in this section. The training was provided by Dr Pip Logan, CI; Dr Annie McCluskey, external expert; Professor Marion Walker, Professor of Stroke Rehabilitation; and Dr Matt Leighton, Trial Manager. The training day provided information on the following:

• An overview of the multicentre outdoor mobility rehabilitation study.

• Roles and responsibilities of those working on the study, and lines of communication and help.

• Information on the earlier single-site outdoor mobility study.

• The mobility outcome measures being used in the outdoor mobility rehabilitation study.

• Timings of baseline visits, intervention visits and follow-up visits.

• The outdoor mobility rehabilitation study documentation.

• Goal setting.

• The role of the Stroke Research Network.

• The role of the Collaboration in Leadership in Applied Health Research and Care (CLAHRC).

• Information on CLAHRC trials being completed.

• Information on an Australian study that audited the amount of outdoor mobility training being incorporated into therapy intervention programmes. The barriers behind including outdoor mobility intervention were studied, training on outdoor mobility was provided, and a repeat audit of outdoor mobility intervention was completed.

Published papers

The following published papers are included in the final section of the manual:

Logan PA, Gladman JRF, Radford KA. The use of transport by stroke patients. Br J Occup Ther 2001;64:261–4.

Logan PA, Gladman JRF, Avery A, Walker MF, Dyas J, Groom L. Randomised controlled trial of an occupational therapy intervention to increase outdoor mobility after stroke. BMJ 2004;329:1372–5.

Logan PA, Walker MF, Gladman JRF. Description of an occupational therapy intervention aimed at improving outdoor mobility. Br J Occup Ther 2006;69:1, 2–6.