Agile Development of a Digital Exposure Treatment for Youth with Chronic Musculoskeletal Pain

敏捷开发针对患有慢性肌肉骨骼疼痛的青少年的数字暴露治疗

基本信息

批准号：
10454233
负责人：
Lauren Elisabeth Harrison
金额：
$ 15.24万
依托单位：
STANFORD UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-07-20 至 2026-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10454233
关键词：
Active Learning Adherence Adolescence Adolescent Adult Affect Age Arthritis Behavior Therapy Biomechanics COVID-19 pandemic Cellular Phone Childhood Clinical Clinical Research Clinical Trials Computers Country Data Data Collection Development Development Plans Devices Distress Effectiveness Evaluation Evidence based intervention Evidence based program Experimental Designs Feedback Fright Funding Goals Grant Health Services Accessibility Impairment Individual Intervention Interview Maintenance Measures Medicine Mentors Mentorship Methods Modeling Monitor Musculoskeletal Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases Outpatients Pain Parents Participant Patients Phase Physical activity Prevention Process Provider Randomized Randomized Controlled Trials Research Research Methodology Research Support Risk Scientist Secure Services Structure Tablets Teenagers Time Training Treatment Effectiveness Waiting Lists Writing Youth actigraphy adherence rate barrier to care behavioral health intervention biomechanical test career career development chronic musculoskeletal pain chronic pain clinical care cohort cost design diaries digital digital health digital intervention disability dissemination science evidence base experience flexibility follow-up functional disability high risk implementation science innovation innovative technologies insight joint biomechanics mHealth multidisciplinary opioid misuse pain reduction patient oriented pilot trial prototype remote assessment response retention rate satisfaction social societal costs statistics theories user centered design user-friendly

项目摘要

Abstract Chronic musculoskeletal (MSK) pain affects the lives of over a quarter of youth, with societal costs exceeding $19.5 billion dollars in the U.S. each year. The impact of chronic MSK pain in adolescence is felt into adulthood and is a documented risk for opioid misuse. There are a number of efficacious behavioral interventions for adolescents with chronic pain, but many access-to-care barriers exist, highlighting the critical need to develop digitally delivered behavioral interventions to drastically increase reach. Graded exposure is a theory- driven, individually-tailored intervention for individuals with chronic pain targeting pain-related impairment by exposing patients to previously feared and avoided activities. This project seeks to develop and evaluate the feasibility and preliminary effectiveness of a digital exposure treatment (iGET Living) for adolescents with chronic musculoskeletal (MSK) pain and their parents, utilizing a sequential replicated and randomized single-case experimental design (SCED) and incorporating innovative technology for remote biomechanical assessment. The central hypothesis is iGET Living will be acceptable and feasible for youth with chronic MSK pain and their parents and will be effective at alleviating functional disability and pain-related distress. Agile research methods will allow for a rapid, iterative development and evaluation of the intervention, yielding a clinically useful solution. This proposal includes a comprehensive training plan under the guidance of mentors with expertise across study aims. Dr. Harrison will obtain specialized training in 1) user-centered design and agile development of digital interventions, 2) clinical research and trial execution, 3) intervention optimization, dissemination, and implementation science, 4) innovative, remote assessment of biomechanical function, 5) advanced qualitative and quantitative statistics, and 6) experiential learning in grant-writing. Research: Aim 1: In an iterative, user- experience design process, Dr. Harrison and her team will develop iGET Living for adolescents with chronic MSK pain and their parents. Data regarding comprehensiveness and acceptability will be collected via interviews with patients and parents. Clinicians specialized in pediatric chronic pain will provide feedback on how providers might integrate into practice, who they would refer, and potential barriers to utilization. Aim 2: Dr. Harrison will evaluate preliminary feasibility and effectiveness of iGET Living to reduce pain-related distress and functional disability utilizing SCED with multiple measures. Successful completion of these aims will provide the opportunity to rapidly evaluate treatment effectiveness and inform iterative development of iGET Living to prepare subsequent RCTs. The strong mentorship team, specialized career development training, and proposed research plan will allow Dr. Harrison to gain the expertise needed to seek R-level funding and achieve her long- term career goal of becoming an independent clinician-scientist with expertise in developing digital interventions for youth with chronic pain and their parents.

抽象的慢性肌肉骨骼 (MSK) 疼痛影响着超过四分之一青少年的生活，社会成本超过美国每年195亿美元。青春期慢性 MSK 疼痛的影响会持续到成年期并且是有记录的阿片类药物滥用风险。有许多有效的行为干预措施患有慢性疼痛的青少年，但存在许多获得护理的障碍，突出表明迫切需要发展以数字方式提供行为干预措施，以大幅扩大影响范围。分级曝光是一种理论—— 针对慢性疼痛患者针对疼痛相关损伤进行驱动的、个性化的干预措施让患者参与以前害怕和避免的活动。该项目旨在开发和评估数字暴露治疗（iGET Living）对患有慢性病的青少年的可行性和初步效果肌肉骨骼 (MSK) 疼痛及其父母，利用连续重复和随机的单病例实验设计（SCED）并结合创新技术进行远程生物力学评估。中心假设是 iGET Living 对于患有慢性 MSK 疼痛的青少年及其他们来说是可以接受和可行的父母，将有效减轻功能障碍和疼痛相关的痛苦。敏捷研究方法将允许对干预措施进行快速、迭代的开发和评估，从而产生临床上有用的解决方案。该提案包括在具有跨学科专业知识的导师指导下的全面培训计划目标。 Harrison博士将获得以下方面的专业培训：1）以用户为中心的设计和数字化敏捷开发干预措施，2) 临床研究和试验执行，3) 干预措施优化、传播和实施科学，4) 生物力学功能的创新远程评估，5) 先进的定性和定量统计，以及 6) 拨款写作中的体验式学习。研究：目标 1：在迭代中，用户体验设计过程中，Harrison 博士和她的团队将为患有慢性病的青少年开发 iGET Living MSK 痛苦和他们的父母。有关全面性和可接受性的数据将通过访谈收集与患者和家长。专门从事儿科慢性疼痛的临床医生将提供有关提供者如何进行的反馈可能会融入实践，他们会推荐谁，以及使用的潜在障碍。目标 2：哈里森博士将评估 iGET Living 减少疼痛相关痛苦和功能的初步可行性和有效性残疾利用 SCED 采取多种措施。成功完成这些目标将提供机会快速评估治疗效果并为 iGET Living 的迭代开发提供信息，以做好准备随后的随机对照试验。强大的导师团队、专业的职业发展培训、建议研究计划将使哈里森博士获得寻求 R 级资助并实现她的长期目标所需的专业知识长期职业目标是成为一名独立的临床医生科学家，具有开发数字干预措施的专业知识对于患有慢性疼痛的青少年及其父母。