Department of Anesthesiology & Pain Medicine, University of Washington School of Medicine, United States; Center for Child Health, Behavior & Development, Seattle Children's Research Institute, United States.
Center for Child Health, Behavior & Development, Seattle Children's Research Institute, United States.
Contemp Clin Trials. 2018 Nov;74:55-60. doi: 10.1016/j.cct.2018.10.003. Epub 2018 Oct 2.
Approximately 5-8% of children report severe chronic pain and disability. Although evidence supports pain-self management as effective for reducing pain and disability, most youth do not have access to psychological intervention. Our prior studies demonstrate that an existing internet-delivered pain self-management program (WebMAP) can reduce barriers to care, is feasible, acceptable, and is effective in reducing pain-related disability in youth with chronic pain. The current trial seeks to: 1) determine the effectiveness of a mobile app version of WebMAP for improving patient pain-related outcomes, and 2) evaluate a novel implementation strategy to maximize the public health impact of the intervention including the determination of adoption, reach, and sustainability of WebMAP in specialty clinics serving children with chronic pain in the United States.
This hybrid effectiveness-implementation cluster randomized controlled trial employs a stepped wedge design in which the WebMAP mobile intervention is sequentially implemented in 8 specialty pain clinics following a usual care period. This trial aims to enroll a minimum of 120 youth (ages 10-17) who have chronic pain. Outcome analyses will determine effectiveness of treatment on adolescent pain-related outcomes as well as public health impact via reach, adoption, implementation, and maintenance.
This trial examines an innovative approach to evaluate a technology-delivered pain self-management program for youth with chronic pain. Findings are expected to yield a strategic approach for delivering a digital pain management program for youth with chronic pain that can be sustained in clinical settings. Clinical Trial Registration #: NCT03332563.
大约 5-8%的儿童报告有严重的慢性疼痛和残疾。尽管有证据表明疼痛自我管理对于减轻疼痛和残疾是有效的，但大多数青少年无法获得心理干预。我们之前的研究表明，现有的互联网疼痛自我管理项目（WebMAP）可以减少护理障碍，具有可行性、可接受性，并且可以有效减少慢性疼痛青少年的疼痛相关残疾。目前的试验旨在：1）确定 WebMAP 的移动应用程序版本在改善患者疼痛相关结果方面的有效性，2）评估一种新的实施策略，以最大限度地提高干预措施的公共卫生影响，包括确定在美国为慢性疼痛儿童服务的专业诊所中 WebMAP 的采用、覆盖面和可持续性。
这项混合有效性-实施的群组随机对照试验采用了逐步楔形设计，WebMAP 移动干预在常规护理期后，按顺序在 8 个专业疼痛诊所中实施。本试验旨在招募至少 120 名患有慢性疼痛的青少年（年龄 10-17 岁）。结果分析将确定治疗对青少年疼痛相关结果的有效性，以及通过覆盖面、采用、实施和维持来评估公共卫生的影响。
本试验检验了一种针对慢性疼痛青少年的基于技术的疼痛自我管理项目的创新方法。研究结果有望为在临床环境中为慢性疼痛青少年提供数字疼痛管理项目提供一种可持续的战略方法。临床试验注册号：NCT03332563。
