Abstract
One-third of stroke patients are dependent on others to get outside their homes. This can cause people to become housebound, leading to increased immobility, poor health, isolation and misery. There is some evidence that outdoor mobility rehabilitation can reduce these limitations. To test the clinical effectiveness and cost-effectiveness of an outdoor mobility rehabilitation intervention for stroke patients. Multicentre, parallel-group randomised controlled trial, with two groups allocated at a 1 : 1 ratio plus qualitative participant interviews. Fifteen UK NHS stroke services throughout England, Scotland and Wales. A total of 568 stroke patients who wished to get out of the house more often, mean age of 71 years: 508 reached the 6-month follow-up and 10 were interviewed. Control was delivered prior to randomisation to all participants, and consisted of verbal advice and transport and outdoor mobility leaflets. Intervention was a targeted outdoor mobility rehabilitation programme delivered by 29 NHS therapists to 287 randomly chosen participants for up to 12 sessions over 4 months. Primary outcome was participant health-related quality of life, measured by the Short Form questionnaire-36 items, version 2 (Social Function domain), 6 months after baseline. Secondary outcomes were functional ability, mobility, number of journeys (from monthly travel diaries), satisfaction with outdoor mobility (SWOM), psychological well-being and resource use [health care and Personal Social Services (PSS)] 6 months after baseline. Carer well-being was recorded. All outcome measures were collected by post and repeated 12 months after baseline. Outcomes for the groups were compared using statistical significance testing and adjusted for multiple membership to account for the effect of multiple therapists at different sites. Interviews were analysed using interpretive phenomenology to explore confidence. A median of seven intervention sessions [interquartile range (IQR) 3-7 sessions], median duration of 369 minutes (IQR 170-691.5 minutes) per participant was delivered. There was no significant difference between the groups on health-related quality of life (social function). There were no significant differences between groups in functional ability, psychological well-being or SWOM at 6- or 12-month follow-ups. There was a significant difference observed for travel journeys with the intervention group being 42% more likely to make a journey compared with the control group [rate ratio 1.42, 95% confidence interval (95% CI) 1.14 to 1.67] at 6 months and 76% more likely (rate ratio 1.76, 95% CI 1.36 to 1.95) at 12 months. The number of journeys was affected by the therapist effect. The mean incremental cost (total NHS and PSS cost) of the intervention was £3413.75 (95% CI -£448.43 to £7121.00), with an incremental quality-adjusted life-year gain of -0.027 (95% CI -0.060 to 0.007) according to the European Quality of Life-5 Dimensions and -0.003 (95% CI -0.016 to 0.006) according to the Short Form questionnaire-6 Dimensions. At baseline, 259 out of 281 (92.2%) participants in the control group were dissatisfied with outdoor mobility but at the 6-month assessment this had reduced to 77.7% (181/233), a 15% reduction. The corresponding reduction in the intervention group was slightly greater (21%) than 268 out of 287 (93.4%) participants dissatisfied with outdoor mobility at baseline to 189 out of 261 (72.4%) at 6 months. Participants described losing confidence after stroke as being detrimental to outdoor mobility. Recruitment and retention rates were high. The intervention was deliverable by the NHS but had a neutral effect in all areas apart from potentially increasing the number of journeys. This was dependent on the therapist effect, meaning that some therapists were more successful than others. The control appeared to affect change. The outdoor mobility intervention provided in this study to these stroke patients was not clinically effective or cost-effective. However, the provision of personalised information and monthly diaries should be considered for all people who wish to get out more. Current Controlled Trials ISRCTN58683841. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 18, No. 29. See the NIHR Journals Library website for further project information.
Highlights
AimsSampling strategy and recruitmentParticipant sample characteristicsData collection: interviewing approach Data analysisPresentation of the findings ‘Robbed of life’Fear of having another strokeFear of going out/social confidenceTeam confidence/collective efficacyRole confidence ‘It’s not I can’t, it’s I can’: skill mastery ‘Inner strength’ and confidence
It demonstrates that rehabilitation interventions that aim to improve outdoor mobility are appropriate for delivery by NHS therapists and, 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 satisfaction with outdoor mobility (SWOM) but it has to be delivered in a specified way
Summary
AimsSampling strategy and recruitmentParticipant sample characteristicsData collection: interviewing approach Data analysisPresentation of the findings ‘Robbed of life’Fear of having another strokeFear of going out/social confidenceTeam confidence/collective efficacyRole confidence ‘It’s not I can’t, it’s I can’: skill mastery ‘Inner strength’ and confidence. Stroke can have a devastating effect on people’s lives, with half of survivors being dependent on others 6 months later, one-third feeling socially isolated, one-quarter having abnormal moods, and half not getting out of their houses as much as they would like.. One-third of stroke patients are dependent on others to get outside their homes This can cause people to become housebound, leading to increased immobility, poor health, isolation and misery. Stroke patients become housebound, leading to increased immobility, poor health, isolation and misery This diminution of quality of life provides the justification for an intervention aimed at enhancing outdoor mobility for those with mobility restrictions. A Cochrane review concluded that the passive provision of leaflets is not effective
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