Objective To conduct a rigorous feasibility study for a future definitive parallel-group randomised controlled trial (RCT) and economic evaluation of an enhanced rehabilitation package for hip fracture.
Setting Recruitment from 3 acute hospitals in North Wales. Intervention delivery in the community.
Participants Older adults (aged ≥65) who received surgical treatment for hip fracture, lived independently prior to fracture, had mental capacity (assessed by clinical team) and received rehabilitation in the North Wales area.
Intervention Remote randomisation to usual care (control) or usual care+enhanced rehabilitation package (intervention), including six additional home-based physiotherapy sessions delivered by a physiotherapist or technical instructor, novel information workbook and goal-setting diary.
Primary and secondary outcome measures Primary: Barthel Activities of Daily Living (BADL). Secondary measures included Nottingham Extended Activities of Daily Living scale (NEADL), EQ-5D, ICECAP capability, a suite of self-efficacy, psychosocial and service-use measures and costs. Outcome measures were assessed at baseline and 3-month follow-up by blinded researchers.
Results 62 participants were recruited, 61 randomised (control 32; intervention 29) and 49 (79%) completed 3-month follow-up. Minimal differences occurred between the 2 groups for most outcomes, including BADL (adjusted mean difference 0.5). The intervention group showed a medium-sized improvement in the NEADL relative to the control group, with an adjusted mean difference between groups of 3.0 (Cohen's d 0.63), and a trend for greater improvement in self-efficacy and mental health, but with small effect sizes. The mean cost of delivering the intervention was £231 per patient. There was a small relative improvement in quality-adjusted life year in the intervention group. No serious adverse events relating to the intervention were reported.
Conclusions The trial methods were feasible in terms of eligibility, recruitment and retention. The effectiveness and cost-effectiveness of the rehabilitation package should be tested in a phase III RCT.
Trial registration number ISRCTN22464643; Results.
- REHABILITATION MEDICINE
- HEALTH ECONOMICS
- QUALITATIVE RESEARCH
- GERIATRIC MEDICINE
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Contributors NHW was the chief investigator and grant holder, was responsible for study design, conduct and analysis and had overall responsibility for the study and acts as guarantor. JLR was the study manager during data collection and intervention delivery overseeing day-to-day conduct, participant recruitment, methodological input, conducted qualitative analysis for the focus groups. NUD was involved in participant recruitment, acquisition of quantitative and qualitative data and analysis. NT conducted the statistical analysis for the cohort and feasibility studies. JMC conducted the economic analysis. CAH was the study manager during study set-up, intervention implementation and initial data collection. VM was a coinvestigator, responsible for study design, provided health psychology expertise and methodological oversight throughout the study. ZH gave input to study design, was responsible for statistical analysis design, provided methodological oversight, support for the trial statistician. MW was involved in the conduct of the study including maintenance of trial documentation, acquisition of data, provided administrative support. AWP contributed to qualitative analysis of the focus groups. SA was a coinvestigator, provided orthogeriatric expertise and input on intervention design. AL was a coinvestigator, responsible for study design, provided methodological oversight throughout the study. RTW was a coinvestigator, contributed to study design, provided clinical psychological expertise. CS was a coinvestigator, contributed to methodology and study design, provided physiotherapy and rehabilitation expertise and input on intervention design. PL was a coinvestigator contributed to methodology and study design, provided occupational therapy and rehabilitation expertise and input on intervention design. RTE was a coinvestigator, contributed to study design, was responsible for economic evaluation design. CW was a coinvestigator, contributed to methodology and study design and provided primary care expertise. All authors were involved in drafting, revising and approving this manuscript.
Funding This work was supported by the National Institute for Health Research's Health Technology Assessment Programme, grant number 11/33/03. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA, NIHR, NHS or the Department of Health.
Competing interests NHW, JLR, NUD, MW, NT, JMC, CAH, VM, ZH, SA, AL, RTW, CS, PL, RTE and CW report a grant from NIHR HTA programme, for the conduct of the study. CS reports being a member of the NIHR HSDR board. NHW reports additional grants from Public Health Wales, NIHR HTA and BCUHB, outside the submitted work. JMC and RTE report grants from Public Health Wales, outside the submitted work.
Ethics approval The study received ethical approval from the UK NHS North Wales West Research Ethics Committee—West. Ref 13/WA/0402 and NHS Research and Development approval from the Betsi Cadwalader University Health Board (BCUHB) Internal Review Panel.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement No additional data are available.
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