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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

Authors

Nefyn H. Williams

Jessica L. Roberts

Nafees Ud Din

Nicola Totton

Joanna M. Charles

Claire A. Hawkes

Val Morrison

Hoare Zoe

Michelle Williams

Aaron W. Pritchard

Swapna Alexander

Andrew Lemmey

Robert T. Woods

Catherine Mary Sackley

PIP LOGAN pip.logan@nottingham.ac.uk
Professor of Rehabilitation Research

Rhiannon T. Edwards

Clare Wilkinson



Abstract

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.

Citation

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
Journal BMJ Open
Electronic ISSN 2044-6055
Publisher BMJ Publishing Group
Peer Reviewed Peer Reviewed
Volume 6
Issue 10
Article Number e012422
Pages 1-13
DOI https://doi.org/10.1136/bmjopen-2016-012422
Public URL http://eprints.nottingham.ac.uk/id/eprint/40345
Publisher URL http://bmjopen.bmj.com/content/6/10/e012422.info
Copyright Statement Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0

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Copyright Statement
Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0





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