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  • Nefyn Williams
    Department of Molecular and Clinical Pharmacology, University of Liverpool
  • Susanna Dodd
    Department of Molecular and Clinical Pharmacology, University of Liverpool
  • Ben Hardwick
    Department of Molecular and Clinical Pharmacology, University of Liverpool
  • Dannii Clayton
    Department of Molecular and Clinical Pharmacology, University of Liverpool
  • Rhiannon Tudor Edwards
  • Joanna Mary Charles
  • Phillipa Logan
    University of Nottingham
  • Monica Busse
    Cardiff Metropolitan University
  • Ruth Lewis
  • Toby O Smith
    University of East Anglia
  • Catherine Sackley
    University of Nottingham
  • Val Morrison
  • Andrew Lemmey
  • Patricia Masterson-Algar
  • Lola Howard
    Department of Molecular and Clinical Pharmacology, University of Liverpool
  • Sophie Hennessy
    Department of Molecular and Clinical Pharmacology, University of Liverpool
  • Claire Soady
    Department of Molecular and Clinical Pharmacology, University of Liverpool
  • Penelope Ralph
    Department of Molecular and Clinical Pharmacology, University of Liverpool
  • Susan Dobson
    Department of Molecular and Clinical Pharmacology, University of Liverpool
  • Shanaz Dorkenoo
    Health and Care Research Wales (HCRW)
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.

Allweddeiriau

Iaith wreiddiolSaesneg
Tudalennau (o-i)e039791
CyfnodolynBMJ Open
Cyfrol10
Rhif y cyfnodolyn10
Dynodwyr Gwrthrych Digidol (DOIs)
StatwsCyhoeddwyd - 16 Hyd 2020

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