BMJ open · 2020
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).
Протокол клинического исследованияСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Williams Nefyn, Dodd Susanna, Hardwick Ben, Clayton Dannii, Edwards Rhiannon Tudor, Charles Joanna Mary, Logan Phillipa, Busse Monica, Lewis Ruth, Smith Toby O, Sackley Catherine, Morrison Val, Lemmey Andrew, Masterson-Algar Patricia, Howard Lola, Hennessy Sophie, Soady Claire, Ralph Penelope, Dobson Susan, Dorkenoo Shanaz
Аннотация
INTRODUCTION: Proximal femoral (hip) fracture is common, serious and costly. Rehabilitation may improve functional recovery but evidence of effectiveness and cost-effectiveness are 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: National Health Service research ethics approval reference 18/NE/0300. Results will be disseminated by peer-reviewed publication.
TRIAL REGISTRATION NUMBER: ISRCTN28376407; Pre-results registered on 23 November 2018.
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: National Health Service research ethics approval reference 18/NE/0300. Results will be disseminated by peer-reviewed publication.
TRIAL REGISTRATION NUMBER: ISRCTN28376407; Pre-results registered on 23 November 2018.