Nefyn H. Williams
Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR): study protocol for a phase II randomised feasibility study of a multidisciplinary rehabilitation package following hip fracture
Williams, Nefyn H.; Roberts, Jessica L.; Ud Din, Nafees; Totton, Nicola; Charles, Joanna M.; Hawkes, Claire A.; Morrison, Val; Zoe, Hoare; Williams, Michelle; Pritchard, Aaron W.; Alexander, Swapna; Lemmey, Andrew; Woods, Robert T.; Sackley, Catherine Mary; Logan, Phillipa A.; Edwards, Rhiannon T.; Wilkinson, Clare
Jessica L. Roberts
Nafees Ud Din
Joanna M. Charles
Claire A. Hawkes
Aaron W. Pritchard
Robert T. Woods
Catherine Mary Sackley
PIP LOGAN firstname.lastname@example.org
Professor of Rehabilitation Research
Rhiannon T. Edwards
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.
Williams, N. H., Roberts, J. L., Ud Din, N., Totton, N., Charles, J. M., Hawkes, C. A., …Wilkinson, C. (2016). Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR): study protocol for a phase II randomised feasibility study of a multidisciplinary rehabilitation package following hip fracture. BMJ Open, 6(10), 1-13. https://doi.org/10.1136/bmjopen-2016-012422
|Journal Article Type||Article|
|Acceptance Date||Aug 25, 2016|
|Online Publication Date||Oct 5, 2016|
|Publication Date||Oct 1, 2016|
|Deposit Date||Feb 6, 2017|
|Publicly Available Date||Feb 6, 2017|
|Publisher||BMJ Publishing Group|
|Peer Reviewed||Peer Reviewed|
|Copyright Statement||Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0|
Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0
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