Evaluation of a Smartwatch-based Intervention Providing Feedback of Daily Activity within a Research-Naive Stroke Ward: a pilot randomised controlled trial

Background. The majority of stroke patients are inactive outside formal therapy sessions. Tailored activity feedback via a Smartwatch has the potential to increase inpatient activity. Objective. to identify the challenges and support needed by ward staff and researchers and to examine the feasibility of conducting a randomised controlled trial (RCT) using Smartwatch activity monitors in research naive rehabilitation wards. Objectives (Phase 1 and 2) were to report any challenges and support needed and determine the recruitment and retention rate, completion of outcome measures, Smartwatch adherence rate (Phase 2 only) readiness to randomise, adherence to protocol (intervention fidelity) and potential for effect. Methods. First admission, stroke patients (onset <4 months) aged 40-75, able to walk 10m prior to stroke and follow a two stage command with sufficient cognition and vision (clinically judged) were recruited within the Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine. Phase 1: a non-randomised observation phase (to allow practice of protocol) - patients received no activity feedback. Phase 2: a parallel single-blind pilot RCT. Patients were randomised into one of two groups: to receive daily activity feedback over a nine hour period, or to receive no activity feedback. EQ-5D-5L, WHODAS and RMI were conducted at baseline, discharge and three months post-discharge. Descriptives statistics were performed on recruitment, retention, completion and activity counts as well as adherence to protocol. Results. Out of 470 ward admissions, 11% were recruited across the two phases, over a 30-week period. Retention rate at the three months post-discharge was 48%. 22% of patients dropped out post-baseline assessment, 78% completed baseline and discharge admissions, from which 62% were assessed three months post-discharge. Smartwatch data was received from all patients. Patients were correctly randomised into each RCT group. RCT adherence rate