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 to wearing the Smartwatch was 80%. Baseline activity was exceeded for 65% of days in the feedback group compared to 55% of days in the no-feedback group. Conclusions. Delivery of a Smartwatch RCT is feasible in a research naive rehabilitation ward. However, frequent support and guidance of research-naive staff is required to ensure completeness of clinical assessment data and protocol adherence.
Lawrie, SophieDong, YunSteins, DaxXia, ZhidaoEsser, PatrickSun, ShanbinLi, FeiAmor, James D.James, ChristopherIzadi, HooshangChao, YiWade, DerickMayo, NancyDawes, Helen
Faculty of Health and Life Sciences\Department of Sport, Health Sciences and Social Work
Year of publication: 2018Date of RADAR deposit: 2018-09-24