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)
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 use...
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BMJ Publishing Group
2020-10-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/10/e039791.full |
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| author | Ben Hardwick Phillipa Logan Rhiannon Tudor Edwards Susanna Dodd Toby O Smith Lola Howard Ruth Lewis Catherine Sackley Val Morrison Andrew Lemmey Nefyn Williams Monica Busse Dannii Clayton Joanna Mary Charles Patricia Masterson-Algar Sophie Hennessy Claire Soady Penelope Ralph Susan Dobson Shanaz Dorkenoo |
| author_facet | Ben Hardwick Phillipa Logan Rhiannon Tudor Edwards Susanna Dodd Toby O Smith Lola Howard Ruth Lewis Catherine Sackley Val Morrison Andrew Lemmey Nefyn Williams Monica Busse Dannii Clayton Joanna Mary Charles Patricia Masterson-Algar Sophie Hennessy Claire Soady Penelope Ralph Susan Dobson Shanaz Dorkenoo |
| author_sort | Ben Hardwick |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-71eb7bc5a0534b65ae93c658b08e9f16 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-10-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-71eb7bc5a0534b65ae93c658b08e9f162024-11-16T05:45:08ZengBMJ Publishing GroupBMJ Open2044-60552020-10-01101010.1136/bmjopen-2020-039791Protocol 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)Ben Hardwick0Phillipa Logan1Rhiannon Tudor Edwards2Susanna Dodd3Toby O Smith4Lola Howard5Ruth Lewis6Catherine Sackley7Val Morrison8Andrew Lemmey9Nefyn Williams10Monica Busse11Dannii Clayton12Joanna Mary Charles13Patricia Masterson-Algar14Sophie Hennessy15Claire Soady16Penelope Ralph17Susan Dobson18Shanaz Dorkenoo19Liverpool Clinical Trials Centre, University of Liverpool Faculty of Health and Life Sciences, Liverpool, UKSchool of Medicine, University of Nottingham, Nottingham, UKCentre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UKDepartment of Health Data Science, University of Liverpool, Liverpool, UKSchool of Health Sciences, University of East Anglia Faculty of Medicine and Health Sciences, Norwich, Norfolk, UKLiverpool Clinical Trials Centre, University of Liverpool Faculty of Health and Life Sciences, Liverpool, UKNorth Wales Centre for Primary Care Research, School of Medical and Health Sciences, Bangor University, Bangor, UKUniversity of Nottingham Faculty of Medicine and Health Sciences, Nottingham, UKSchool of Psychology, Bangor University, Bangor, UKSchool of Sport, Health and Exercise Sciences, Bangor University, Bangor, UKPrimary Care, Department of Primary Care and Mental Health, University of Liverpool, Liverpool, UKCentre for Trials Research, Cardiff University, Cardiff, UK2University of Liverpool, Clinical Trials Unit, Liverpool, United KingdomCentre for Health Economics & Medicines Evaluation, Bangor University College of Human Sciences, Bangor, Gwynedd, UKlecturer in health sciencesLiverpool Clinical Trials Centre, University of Liverpool, Liverpool, UKLiverpool Clinical Trials Centre, University of Liverpool Faculty of Health and Life Sciences, Liverpool, UKDepartment of Primary Care and Mental Health, University of Liverpool, Liverpool, UKDepartment of Primary Care and Mental Health, University of Liverpool Faculty of Health and Life Sciences, Liverpool, UKInvolving People Network, Health and Care Research Wales, Cardiff, UKIntroduction 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.https://bmjopen.bmj.com/content/10/10/e039791.full |
| spellingShingle | Ben Hardwick Phillipa Logan Rhiannon Tudor Edwards Susanna Dodd Toby O Smith Lola Howard Ruth Lewis Catherine Sackley Val Morrison Andrew Lemmey Nefyn Williams Monica Busse Dannii Clayton Joanna Mary Charles Patricia Masterson-Algar Sophie Hennessy Claire Soady Penelope Ralph Susan Dobson Shanaz Dorkenoo 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) BMJ Open |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/10/10/e039791.full |
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