A definitive multi-centre randomised controlled trial and economic evaluation of a community-based rehabilitation package following hip fracture. Acronym: Fracture in the Elderly Multidisciplinary Rehabilitation - Phase III (FEMuR III)
Every year, roughly 446 older people recovering from hip fracture surgery will receive a structured workbook, a goal-setting diary, and six extra therapy sessions at home, rather than standard follow-up care. This matters because hip fractures are devastating for older adults—they often lead to long-term disability, loss of independence, and high NHS costs. Current community rehabilitation is inconsistent, with no proven package to boost patients’ confidence and physical recovery after hospital discharge. The FEMuR III trial directly tests whether a systematic, enhanced rehabilitation programme can close that gap. If the intervention proves effective and cost-effective, the NHS could adopt a standardised, community-based rehabilitation package for hip fracture patients. That would mean more people regaining the ability to walk, dress, and manage daily activities at home, reducing the need for residential care or repeated hospital visits. For health service planners, it offers a scalable, evidence-based model that could be rolled out across acute trusts, improving outcomes for thousands of older patients each year while potentially saving public money.
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Study Design Multi-centre, pragmatic, parallel-group, 12-month superiority phase III randomised controlled trial (RCT), 1:1 allocation ratio, stratified by gender and site. The RCT will compare the effectiveness and cost-effectiveness of an enhanced rehabilitation package for older people recovering from surgical repair of proximal hip fracture with usual care. There will be concurrent process and economic evaluations, and an internal pilot phase. Economic evaluation will be a cost-utility analysis from a health service and personal social care perspective. Setting Participants recruited on orthopaedic and rehabilitation wards in 12 acute hospital sites; intervention delivered in the community following hospital discharge. Target population Patients recovering from surgical treatment for proximal femoral fracture and their informal and primary (familial) carers. Inclusion criteria: age 60 years or older; recent proximal hip fracture; surgical repair by replacement arthroplasty or internal fixation; living and receiving rehabilitation from the NHS in the area covered by trial sites. Exclusion criteria: living in residential or nursing homes prior to hip fracture; lacking mental capacity to give informed consent. Health technology being assessed An enhanced community-based rehabilitation intervention designed to improve patients’ self-efficacy with a workbook, and increase the amount and quality of patients’ practice of physical exercise and activities of daily living with a goal-setting diary and six additional therapy sessions. Measurement of costs and outcomes Outcome measurement at baseline, 4 and 12 months follow-up. Primary effectiveness outcome measure is the NEADL scale [1]. Primary economic outcome measure is EuroQol EQ-5D-3L [2]. Secondary outcome measure is HADS [3]. Process measures (potential mediators of outcomes): Visual Analogue Scale (VAS) for hip pain intensity [4], Falls Efficacy Scale – International [5,6], VAS for Fear of Falling [7], Abbreviated Mental Test Score [8]. Objective measurement of physical function will be assessed by the researcher at baseline using the grip strength test [9-11], and at 4 and 12 months using the short physical performance battery of tests in the patient's home [12-13]. Carers will complete the Caregiver Strain Index [14] and HADS [3]. Economic evaluation has a public sector multi-agency perspective. Participant service use obtained from Client Service Receipt Inventory (CSRI) [15]. Quality Adjusted Life Years calculated from EuroQol EQ-5D(3L) [2]. Sample size In order to detect a difference of 2.4 in NEADL [16] using ANCOVA, if the SD is 10, R squared of co-variate 0.52, with 5% significance, 90% power and 79% retention rate, the sample size would need to be 446. Project timetable including recruitment rate Permissions (Month -4 to 1); study set up (Month 1 to 3); site training (Month 4 to 8); internal pilot (Month 9 to 14); main trial recruitment (Month 15 to 22); trial follow-up (Month 20 to 34); outcome measurement (Months 9 to 36); data analysis (Month 20 to 40); writing report (Month 41 to 42). Over 12 months we will screen 4309 patients, and if 1939 (45%) are eligible we plan to recruit recruit 446 (23%). Expertise in team Statistics (SD); health economics (RE), trial management (JR); primary care (NW), physiotherapy (CS, MB, TS); occupational therapy (PL); patient and public involvement (SD); health psychology (VM), exercise physiology (AL).
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