title: Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR): study protocol for a phase II randomised feasibility study of a multidisciplinary rehabilitation package following hip fracture [ISRCTN22464643].
abstract: BACKGROUND
  Proximal femoral fracture is a common, major health problem in old age resulting in loss of functional independence and a high-cost burden on society, with estimated health and social care costs of £2.3 billion per year in the UK. Rehabilitation has the potential to maximise functional recovery and maintain independent living, but evidence of effectiveness is lacking. Usual rehabilitation care is delivered by a multi-disciplinary team in the hospital and in the community. An 'enhanced rehabilitation' intervention has been developed consisting of a workbook, goal-setting diary and extra therapy sessions, designed to improve self-efficacy and increase the amount and quality of the practice of physical exercise and activities of daily living.
  
  
  METHODS
  This paper describes the design of a phase II study comprising an anonymous cohort of all proximal femoral fracture patients admitted to the three acute hospitals in Betsi Cadwaladr University Health Board over a 6-month period with a randomised feasibility study comparing the enhanced rehabilitation intervention with usual care. These will assess the feasibility of a future definitive randomised controlled trial and concurrent economic evaluation in terms of recruitment, retention, outcome measure completion, compliance with the intervention and fidelity of delivery, health service use data, willingness to be randomised and effect size for a future sample size calculation. Focus groups will provide qualitative data to contribute to the assessment of the acceptability of the intervention amongst patients, carers and rehabilitation professionals and the feasibility of delivering the planned intervention. The primary outcome measure is function assessed by the Barthel Index. Secondary outcomes measure the ability to perform activities of daily living, anxiety and depression, potential mediators of outcomes such as hip pain, self-efficacy and fear of falling, health utility, health service use, objectively assessed physical function and adverse events. Participants' preference for rehabilitation services will be assessed in a discrete choice experiment.
  
  
  CONCLUSIONS
  Phase II studies are an opportunity to not only assess the feasibility of trial methods but also to compare different methods of outcome measurement and novel methods of obtaining health service use data from routinely collected patient information.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN22464643, UKCRN16677.
authors.affiliation: Schools of Medical and Healthcare Sciences, Bangor University, Bangor, UK ; Betsi Cadwaladr University Health Board, North Wales, UK ; North Wales Organisation for Randomised Trials in Health, Y Wern, Normal Site, Bangor University, Holyhead Road, Bangor, LL57 2PZ UK.
authors.forename: Nefyn H
authors.initials: NH
authors.lastname: Williams
authors.affiliation: Schools of Medical and Healthcare Sciences, Bangor University, Bangor, UK ; North Wales Organisation for Randomised Trials in Health, Y Wern, Normal Site, Bangor University, Holyhead Road, Bangor, LL57 2PZ UK.
authors.forename: Claire
authors.initials: C
authors.lastname: Hawkes
authors.affiliation: Schools of Medical and Healthcare Sciences, Bangor University, Bangor, UK.
authors.forename: Nafees Ud
authors.initials: NU
authors.lastname: Din
authors.affiliation: Schools of Medical and Healthcare Sciences, Bangor University, Bangor, UK ; North Wales Organisation for Randomised Trials in Health, Y Wern, Normal Site, Bangor University, Holyhead Road, Bangor, LL57 2PZ UK.
authors.forename: Jessica L
authors.initials: JL
authors.lastname: Roberts
authors.affiliation: Schools of Medical and Healthcare Sciences, Bangor University, Bangor, UK.
authors.forename: Joanna M
authors.initials: JM
authors.lastname: Charles
authors.affiliation: School of Psychology, Bangor University, Brigantia Building, Penrallt Road, Bangor, LL57 2AS UK.
authors.forename: Val L
authors.initials: VL
authors.lastname: Morrison
authors.affiliation: Schools of Medical and Healthcare Sciences, Bangor University, Bangor, UK ; North Wales Organisation for Randomised Trials in Health, Y Wern, Normal Site, Bangor University, Holyhead Road, Bangor, LL57 2PZ UK.
authors.forename: Zoe
authors.initials: Z
authors.lastname: Hoare
authors.affiliation: Schools of Medical and Healthcare Sciences, Bangor University, Bangor, UK.
authors.forename: Rhiannon T
authors.initials: RT
authors.lastname: Edwards
authors.affiliation: Schools of Medical and Healthcare Sciences, Bangor University, Bangor, UK ; Betsi Cadwaladr University Health Board, North Wales, UK.
authors.forename: Glynne
authors.initials: G
authors.lastname: Andrew
authors.affiliation: Betsi Cadwaladr University Health Board, North Wales, UK.
authors.forename: Swapna
authors.initials: S
authors.lastname: Alexander
authors.affiliation: School of Sports, Health and Exercise Science, Bangor University, George Building, Normal Site, Holyhead Road, Bangor, LL57 2PZ UK.
authors.forename: Andrew B
authors.initials: AB
authors.lastname: Lemmey
authors.affiliation: Schools of Medical and Healthcare Sciences, Bangor University, Bangor, UK ; North Wales Organisation for Randomised Trials in Health, Y Wern, Normal Site, Bangor University, Holyhead Road, Bangor, LL57 2PZ UK.
authors.forename: Bob
authors.initials: B
authors.lastname: Woods
authors.affiliation: School of Health and Social Care Research, King's College, Strand, London, WC2R 2LS UK.
authors.forename: Catherine
authors.initials: C
authors.lastname: Sackley
authors.affiliation: School of Medicine, University of Nottingham, University Park, Nottingham, NG7 2RD UK.
authors.forename: Pip
authors.initials: P
authors.lastname: Logan
authors.affiliation: Schools of Medical and Healthcare Sciences, Bangor University, Bangor, UK ; North Wales Organisation for Randomised Trials in Health, Y Wern, Normal Site, Bangor University, Holyhead Road, Bangor, LL57 2PZ UK.
authors.forename: David
authors.initials: D
authors.lastname: Hunnisett
authors.affiliation: Schools of Medical and Healthcare Sciences, Bangor University, Bangor, UK ; North Wales Organisation for Randomised Trials in Health, Y Wern, Normal Site, Bangor University, Holyhead Road, Bangor, LL57 2PZ UK.
authors.forename: Kevin
authors.initials: K
authors.lastname: Mawdesley
authors.affiliation: Schools of Medical and Healthcare Sciences, Bangor University, Bangor, UK.
authors.forename: Clare
authors.initials: C
authors.lastname: Wilkinson
keywords: Acceptability; Cohort; Discrete choice experiment; Economic evaluation; Feasibility; Focus group; Proximal femoral fracture; Randomised controlled trial; Rehabilitation; Self-efficacy