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).

BACKGROUND: A 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/DESIGN: This 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 REGISTRATION: German Clinical Trials Register, DRKS00008863 (Accessed 17 Apr 2019), ISRCTN registry, ISRCTN69957256 (Accessed 17 Apr 2019).

Walking on common ground: a cross-disciplinary scoping review on the clinical utility of digital mobility outcomes.

Physical mobility is essential to health, and patients often rate it as a high-priority clinical outcome. Digital mobility outcomes (DMOs), such as real-world gait speed or step count, show promise as clinical measures in many medical conditions. However, current research is nascent and fragmented by discipline. This scoping review maps existing evidence on the clinical utility of DMOs, identifying commonalities across traditional disciplinary divides. In November 2019, 11 databases were searched for records investigating the validity and responsiveness of 34 DMOs in four diverse medical conditions (Parkinson's disease, multiple sclerosis, chronic obstructive pulmonary disease, hip fracture). Searches yielded 19,672 unique records. After screening, 855 records representing 775 studies were included and charted in systematic maps. Studies frequently investigated gait speed (70.4% of studies), step length (30.7%), cadence (21.4%), and daily step count (20.7%). They studied differences between healthy and pathological gait (36.4%), associations between DMOs and clinical measures (48.8%) or outcomes (4.3%), and responsiveness to interventions (26.8%). Gait speed, step length, cadence, step time and step count exhibited consistent evidence of validity and responsiveness in multiple conditions, although the evidence was inconsistent or lacking for other DMOs. If DMOs are to be adopted as mainstream tools, further work is needed to establish their predictive validity, responsiveness, and ecological validity. Cross-disciplinary efforts to align methodology and validate DMOs may facilitate their adoption into clinical practice.