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：
10678684
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/10678684
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 Education Effectiveness Evaluation Evidence based intervention Evidence based program Experimental Designs Feedback Fright Funding Goals Grant Health Services Accessibility Impairment Individual Intervention Interview Life Cycle Stages Living Wills 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 Vocation Waiting Lists Writing Youth acceptability and feasibility 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 delivery digital health digital intervention disability dissemination science evidence base experience flexibility follow-up functional disability high risk implementation science improved 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

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）疼痛影响着四分之一以上的年轻人的生活，社会成本超过每年在美国$ 195亿美元。慢性MSK疼痛在青春期的影响被感受到成年并且是滥用阿片类药物的风险。有许多有效的行为干预措施患有慢性疼痛的青少年，但存在许多访问障碍，强调了发展的关键需求数字交付的行为干预措施可大大增加覆盖范围。分级暴露是一种理论 - 通过慢性疼痛靶向疼痛相关损害的个体驱动的，单独降低的干预措施暴露患者以前担心和避免的活动。该项目旨在开发和评估慢性青少年的数字暴露疗法（IGET生活）的可行性和初步有效性肌肉骨骼（MSK）疼痛及其父母，利用顺序复制和随机的单例实验设计（SCED），并结合了用于远程生物力学评估的创新技术。中心假设是Iget生活对于患有慢性MSK疼痛及其的年轻人来说是可以接受的和可行的父母，将有效缓解功能障碍和与疼痛有关的困扰。敏捷研究方法将允许对干预措施进行快速的迭代发展和评估，从而产生临床上有用的解决方案。该建议包括在整个研究中具有专业知识的导师的指导下的全面培训计划目标。哈里森博士将在1）以用户为中心的设计和敏捷的数字开发中获得专门培训干预措施，2）临床研究和试验执行，3）干预优化，传播和实施科学，4）创新的生物力学功能远程评估，5）高级定性和定量统计数据，以及6）授予写作中的体验式学习。研究：目标1：在迭代，用户中 - 经验设计过程，哈里森博士和她的团队将开发与慢性青少年的IGET生活 MSK痛苦和他们的父母。有关综合性和可接受性的数据将通过访谈收集与患者和父母。专门从事儿科慢性疼痛的临床医生将提供有关提供者的反馈可能会将他们推荐的人集成到实践中，以及使用的潜在障碍。目标2：哈里森博士将评估IGET生活的初步可行性和有效性，以减少与疼痛有关的困扰和功能通过多种措施使用SCED的残疾。这些目标的成功完成将提供机会快速评估治疗效率并为IGET生活的迭代发展提供准备随后的RCT。强大的指导团队，专业的职业发展培训，并提议研究计划将使哈里森博士能够获得寻求R级资助所需的专业知识并实现长期成为独立临床医生科学家的职业职业目标，具有发展数字干预措施的专业知识对于患有慢性疼痛的年轻人及其父母。