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Protocol for a definitive randomised controlled trial and economic evaluation of a community-based rehabilitation programme following hip fracture: Fracture in the Elderly Multidisciplinary Rehabilitation - Phase III (FEMuR III)

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Authors

  • Nefyn Williams
  • Susanna R. Dodd
  • Ben Hardwick
  • Dannii Clayton
  • Rhiannon Tudor Edwards
  • Joanna Charles
  • Pip Logan
  • Monica Busse
  • Ruth Lewis
  • Toby Smith
  • Catherine Sackley
  • Val Morrison
  • Andrew Lemmey
  • Patricia Masterson Algar
  • Lola Howard
  • Sophie Hennessy
  • Claire Soady
  • Penelope Ralph
  • Susan Dobson
  • Shanaz Dorkenoo

Organisational units

Abstract

Introduction
Proximal femoral (hip) fracture is common, serious and costly. Rehabilitation may improve functional recovery but evidence of effectiveness and cost-effectiveness is lacking. An enhanced rehabilitation intervention was previously developed and a feasibility study tested the methods used for this randomised controlled trial (RCT).
The objectives are to compare the effectiveness and cost-effectiveness of the enhanced rehabilitation programme following surgical repair of proximal femoral fracture in older people compared with usual care.
Methods and analysis
Protocol for phase III, parallel-group, two-armed, superiority, pragmatic RCT with 1:1 allocation ratio. Allocation sequence by minimisation programme with a built in random element. Secure web-based allocation concealment. The two treatments will be usual care (control) and usual care plus an enhanced rehabilitation programme (intervention). The enhanced rehabilitation will consist of a patient-held information workbook, goal-setting diary and up to six additional therapy sessions. Outcome assessment and statistical analysis will be performed blind; patient and carer participants will be unblinded. Outcomes will be measured at baseline, 17 and 52 weeks’ follow-up. Primary outcome at 52 weeks will be the Nottingham Extended Activities of Daily Living scale. Secondary outcomes will measure anxiety and depression, health utility, cognitive status, hip pain intensity, falls self-efficacy, fear of falling, grip strength and physical function. Carer strain, anxiety and depression will be measured in carers. All safety events will be recorded, and serious adverse events will be assessed to determine whether they are related to the intervention and expected.
Concurrent economic evaluation will be a cost-utility analysis from a health service and personal social care perspective. An embedded process evaluation will determine the mechanisms and processes that explain the implementation and impacts of the enhanced rehabilitation programme.
Ethics and dissemination
NHS research ethics approval reference 18/NE/0300. Results will be disseminated by peer-reviewed publication.
Registration details
ISRCTN28376407 registered on 23/11/2018.

Details

Original languageEnglish
JournalBMJ Open
Publication statusAccepted/In press - 17 Jul 2020
Peer-reviewedYes

Keywords

    Research areas

  • Hip fracture, Trauma, Falls, Community rehabilitation, Domicilary, Physiotherapy, Occupational therapy

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