Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario.
Institute of Health Policy, Management & Evaluation, University of Toronto, Toronto, Ontario.
Rheumatology (Oxford). 2021 Jan 5;60(1):196-206. doi: 10.1093/rheumatology/keaa178.
To evaluate the feasibility and preliminary effectiveness of iCanCope with Pain (iCanCope), a smartphone-based pain self-management program, in adolescents with JIA. iCanCope featured symptom tracking, goal-setting, pain coping skills and social support.
A two-arm pilot randomized controlled trial was used to evaluate the iCanCope app compared with a version with symptom tracking only. Primary (feasibility) outcomes were: participant accrual/attrition rates, success of app deployment, acceptability and adherence. Secondary (preliminary effectiveness) outcomes were: pain intensity, pain-related activity limitations and health-related quality of life. Outcomes were assessed at baseline and 8 weeks. Adherence was defined as the proportion of completed symptom reports: 'low' (≤24%); 'low-moderate' (25-49%); 'high-moderate' (50-75%); or 'high' (76-100%). Linear mixed models were applied for preliminary effectiveness analyses as per intention-to-treat.
Adolescents (N = 60) were recruited from three paediatric rheumatology centres. Rates of accrual and attrition were 82 and 13%, respectively. Both apps were deployed with high success (over 85%) and were rated as highly acceptable. Adherence was similar for both groups, with most participants demonstrating moderate-to-high adherence. Both groups exhibited a clinically meaningful reduction in pain intensity (≥1 point) that did not statistically differ between groups. There were no significant changes in activity limitations or health-related quality of life.
The iCanCope pilot randomized controlled trial was feasible to implement in a paediatric rheumatology setting. Both apps were deployed successfully, with high acceptability, and were associated with moderate-to-high adherence. Preliminary reductions in pain intensity warrant a future trial to evaluate effectiveness of iCanCope in improving health outcomes in adolescents with JIA.
ClinicalTrials.gov identifier: NCT02764346.
评估基于智能手机的疼痛自我管理程序 iCanCope 在青少年 JIA 患者中的可行性和初步疗效。iCanCope 的特点是症状跟踪、目标设定、疼痛应对技能和社会支持。
采用双臂试验性随机对照试验评估 iCanCope 应用程序与仅具有症状跟踪的版本相比的效果。主要（可行性）结果是：参与者招募/流失率、应用程序部署的成功率、可接受性和依从性。次要（初步疗效）结果是：疼痛强度、与疼痛相关的活动受限和健康相关的生活质量。在基线和 8 周时评估这些结果。依从性定义为完成症状报告的比例：“低”（≤24%）；“低-中度”（25-49%）；“中-高度”（50-75%）；或“高”（76-100%）。按照意向治疗原则，采用线性混合模型进行初步疗效分析。
从三个儿科风湿病中心招募了青少年（N=60）。招募率和流失率分别为 82%和 13%。两种应用程序的部署成功率均超过 85%，且评价均为高度可接受。两组的依从性相似，大多数参与者表现出中高度的依从性。两组患者的疼痛强度均有明显下降（≥1 分），且组间无统计学差异。活动受限或健康相关的生活质量无显著变化。
iCanCope 初步随机对照试验在儿科风湿病环境中实施是可行的。两种应用程序均成功部署，具有高度可接受性，且与中高度的依从性相关。初步降低疼痛强度提示需要进一步的试验来评估 iCanCope 在改善青少年 JIA 患者健康结局方面的疗效。
ClinicalTrials.gov 标识符：NCT02764346。
