Multifactorial intervention for hip and pelvic fracture patients with mild to moderate cognitive impairment: study protocol of a dual-centre randomised controlled trial (OF-CARE).

backgroundA hip or pelvic fracture is a major fall-related injury which often causes a decline in mobility performance and physical activity. Over 40% of patients with hip fracture have cognitive impairment or dementia and poorer rehabilitation outcomes than those without cognitive impairment. In this subgroup, there is a lack of evidence on the best practices supporting recovery. The main aim of this study is to investigate the effects of a transitional care intervention after inpatient rehabilitation on physical activity and functional performance in this group of cognitively impaired patients. METHODS/

designThis dual-centre, randomised controlled trial compares a multifactorial intervention with usual care as control condition. Two hundred and forty community-dwellers (≥ 65 years) with a hip or pelvic fracture and mild to moderate cognitive impairment (MMSE 17-26) are recruited at the end of inpatient rehabilitation. The four-month intervention consists of (a) an individually tailored, progressive home exercise program and physical activity promotion delivered by professional instructors and lay instructors (two home visits per week) and (b) a long-term care counselling approach addressing unmet care needs, pleasurable activities, and caregiver issues if needed. Primary outcome parameters are physical activity, measured as daily walking duration with an accelerometer-based activity monitor (activPAL™) over 72 h, and functional performance, assessed with Short Physical Performance Battery sum scores. Secondary outcome parameters are fear of falling, fall related self-efficacy, falls, quality of life, depression and activity of daily living. Data are collected at the end of rehabilitation, before the intervention at the patient's home (baseline), after four months (post-intervention), and seven months (follow-up). In addition to completer and intent-to-treat analyses of outcomes, economic data and incremental cost-effectiveness are analysed. DISCUSSION: Existing service models of volunteer services and legal counselling provided by care counsellors were considered when developing the intervention protocol. Therefore, it should be feasible to translate and deliver the intervention into real-world practice if it has been demonstrated to be effective.

trial registrationGerman Clinical Trials Register, DRKS00008863 (Accessed 17 Apr 2019), ISRCTN registry, ISRCTN69957256 (Accessed 17 Apr 2019).