Lawrie Sophie, Dong Yun, Steins Dax, Xia Zhidao, Esser Patrick, Sun Shanbin, Li Fei, Amor James D, James Christopher, Izadi Hooshang, Cao Yi, Wade Derick, Mayo Nancy, Dawes Helen
1Centre for Movement, Occupational and Rehabilitation Sciences (MOReS), Department of Sport, Health Sciences and Social Work, Oxford Brookes University, Headington Campus, Headington Road, Gipsy Lane, Oxford, OX3 0BP UK.
2Rehabilitation Centre, the Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Hefei, Anhui Province China.
Pilot Feasibility Stud. 2018 Oct 6;4:157. doi: 10.1186/s40814-018-0345-x. eCollection 2018.
The majority of stroke patients are inactive outside formal therapy sessions. Tailored activity feedback via a smartwatch has the potential to increase inpatient activity. The aim of the study was 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.
First admission, stroke patients (onset < 4 months) aged 40-75, able to walk 10 m 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 9-h period or to receive no activity feedback. EQ-5D-5L, WHODAS and RMI were conducted at baseline, discharge and 3 months post-discharge. Descriptive statistics were performed on recruitment, retention, completion and activity counts as well as adherence to protocol.
Out of 470 ward admissions, 11% were recruited across the two phases, over a 30-week period. Retention rate at 3 months post-discharge was 48%. Twenty-two percent of patients dropped out post-baseline assessment, 78% completed baseline and discharge admissions, from which 62% were assessed 3 months post-discharge. Smartwatch data were 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.
Delivery of a smartwatch RCT is feasible in a research-naive rehabilitation ward. However, frequent support and guidance of research-naive staff are required to ensure completeness of clinical assessment data and protocol adherence.
ClinicalTrials.gov Identifier, NCT02587585-30th September 2015.
大多数中风患者在正规治疗课程之外缺乏活动。通过智能手表提供量身定制的活动反馈有可能增加住院患者的活动量。本研究的目的是确定病房工作人员和研究人员所面临的挑战及所需支持，并检验在对研究缺乏经验的康复病房中使用智能手表活动监测器进行随机对照试验（RCT）的可行性。目标（第1阶段和第2阶段）是报告任何挑战及所需支持，并确定招募和保留率、结局指标的完成情况、智能手表的依从率，（仅第2阶段）随机分组的准备情况、对方案的依从性（干预保真度）和效果潜力。
在安徽中医药大学第二附属医院招募首次入院、年龄在40 - 75岁、中风发作时间<4个月、中风前能够行走10米且具有足够认知和视力（临床判断）以遵循两阶段指令的中风患者。第1阶段：非随机观察阶段（以允许方案实践）——患者未接受活动反馈。第2阶段：平行单盲试点RCT。患者被随机分为两组之一：在9小时内接受每日活动反馈或不接受活动反馈。在基线、出院时和出院后3个月进行EQ - 5D - 5L、WHODAS和RMI评估。对招募、保留、完成情况和活动计数以及对方案的依从性进行描述性统计。
在470例病房入院患者中，在30周内的两个阶段共招募了11%。出院后3个月的保留率为48%。22%的患者在基线评估后退出，78%的患者完成了基线和出院评估，其中62%的患者在出院后3个月接受了评估。所有患者均收到了智能手表数据。患者被正确随机分配到每个RCT组。RCT中智能手表佩戴的依从率为80%。反馈组65% 的天数超过了基线活动量，无反馈组为55%。
在对研究缺乏经验的康复病房中进行智能手表RCT是可行的。然而，需要对缺乏研究经验的工作人员进行频繁的支持和指导，以确保临床评估数据的完整性和对方案的依从性。
ClinicalTrials.gov标识符，NCT02587585 - 2015年9月30日。
