title: Rehabilitation aimed at improving outdoor mobility for people after stroke: a multicentre randomised controlled study (the Getting out of the House Study).
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  To test the clinical effectiveness and cost-effectiveness of an outdoor mobility rehabilitation intervention for stroke patients.
  
  
  METHODS
  Multicentre, parallel-group randomised controlled trial, with two groups allocated at a 1 : 1 ratio plus qualitative participant interviews.
  
  
  METHODS
  Fifteen UK NHS stroke services throughout England, Scotland and Wales.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN58683841.
  
  
  BACKGROUND
  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.
authors.affiliation: Division of Rehabilitation and Ageing, University of Nottingham, Nottingham, UK.
authors.forename: Philippa A
authors.initials: PA
authors.lastname: Logan
authors.affiliation: East Midlands Research Design Service, University of Nottingham, Nottingham, UK.
authors.forename: Sarah
authors.initials: S
authors.lastname: Armstrong
authors.affiliation: Division of Primary Care, University of Nottingham, Nottingham, UK.
authors.forename: Tony J
authors.initials: TJ
authors.lastname: Avery
authors.affiliation: Gateshead PCT, Gateshead Health NHS Foundation Trust, Gateshead, UK.
authors.forename: David
authors.initials: D
authors.lastname: Barer
authors.affiliation: Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.
authors.forename: Garry R
authors.initials: GR
authors.lastname: Barton
authors.affiliation: Division of Rehabilitation and Ageing, University of Nottingham, Nottingham, UK.
authors.forename: Janet
authors.initials: J
authors.lastname: Darby
authors.affiliation: Division of Rehabilitation and Ageing, University of Nottingham, Nottingham, UK.
authors.forename: John R F
authors.initials: JR
authors.lastname: Gladman
authors.affiliation: Division of Rehabilitation and Ageing, University of Nottingham, Nottingham, UK.
authors.forename: Jane
authors.initials: J
authors.lastname: Horne
authors.affiliation: United Lincolnshire Hospitals NHS Trust, Lincoln, UK.
authors.forename: Simon
authors.initials: S
authors.lastname: Leach
authors.affiliation: Institute of Work, Health and Organisations, University of Nottingham, Nottingham, UK.
authors.forename: Nadina B
authors.initials: NB
authors.lastname: Lincoln
authors.affiliation: Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.
authors.forename: Samir
authors.initials: S
authors.lastname: Mehta
authors.affiliation: Service user living in Nottingham, .
authors.forename: Ossie
authors.initials: O
authors.lastname: Newell
authors.affiliation: Gateshead PCT, Gateshead Health NHS Foundation Trust, Gateshead, UK.
authors.forename: Kathleen
authors.initials: K
authors.lastname: O'Neil
authors.affiliation: Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.
authors.forename: Tracey H
authors.initials: TH
authors.lastname: Sach
authors.affiliation: Division of Rehabilitation and Ageing, University of Nottingham, Nottingham, UK.
authors.forename: Marion F
authors.initials: MF
authors.lastname: Walker
authors.affiliation: Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.
authors.forename: Hywel C
authors.initials: HC
authors.lastname: Williams
authors.affiliation: Division of Rehabilitation and Ageing, University of Nottingham, Nottingham, UK.
authors.forename: Lisa J
authors.initials: LJ
authors.lastname: Woodhouse
authors.affiliation: Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.
authors.forename: Mat P
authors.initials: MP
authors.lastname: Leighton
mesh_terms: D000203:Activities of Daily Living; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003362:Cost-Benefit Analysis; D005260:Female; D006040:Goals; D006801:Humans; D008297:Male; D008875:Middle Aged; D051346:Mobility Limitation; D017063:Outcome Assessment, Health Care; D036301:Qualitative Research; D011788:Quality of Life; D012046:Rehabilitation / Q000191:economics / Q000592:standards; D000071939:Stroke Rehabilitation; D011795:Surveys and Questionnaires; D006113:United Kingdom