Optimizing a Sensor-Enabled mHealth Intervention for Adolescents with Suboptimal Asthma Control

针对哮喘控制不佳的青少年优化传感器支持的移动健康干预措施

• 批准号: 10742718
• 负责人: Christopher C Cushing
• 金额: $ 25.01万
• 依托单位: UNIVERSITY OF KANSAS LAWRENCE
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-15 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10742718
• 关键词: Adherence; Adolescent; Adrenal Cortex Hormones; Affect; Age; Agonist; Algorithms; Asthma; Award; Behavior; Behavior Therapy; Caring; Cellular Phone; Childhood Asthma; Chronic Disease; Clinical Trials; Cognition; Data; Development; Diagnosis; Disease; Distal; Dose; Ecosystem; Education; Emotions; Feedback; Future; Goals; Guidelines; Health; Impairment; Informal Social Control; Inhalation; Intervention; Learning; Maintenance; Minority; Modeling; Modification; Monitor; Morbidity - disease rate; Multi-Institutional Clinical Trial; Outcome; Ownership; Patient Self-Report; Pattern; Pharmaceutical Preparations; Phase; Problem Solving; Process; Protocols documentation; Quality of life; Randomized; Regimen; Research; Risk; Schools; Self Management; Site; Symptoms; Technology; Teenagers; Time; United States; Update; Work; Youth; adaptive intervention; behavior change; clinical trial protocol; clinically significant; cloud based; design; digital; digital technology; efficacy trial; evidence base; experience; improved; interest; intervention delivery; intervention effect; mHealth; medication compliance; mobile sensor; multi-site trial; phase 1 designs; pilot test; pilot trial; post intervention; primary outcome; programs; recruit; satisfaction; sensor; skills; smartphone application; standard of care; theories; usability; user centered design

PROJECT SUMMARY Asthma affects 9% of adolescents in the United States and is a leading cause of youth morbidity. National asthma guidelines emphasize the importance of asthma self-management behaviors to control asthma and promote quality of life. Adolescents have suboptimal adherence to asthma self-management behaviors driven by an underdeveloped and highly variable capacity to self-regulate cognitions, emotions, and behaviors; and a normative decrease in parental support while multiple demands are increasing. Each adolescent experiences different threats to their ability to self-regulate at different moments in time, necessitating personalized and adaptive self-regulatory support to increase daily self-management behaviors and achieve sustained asthma control. Smartphones are an optimal mechanism for improving adolescent adherence, however, existing asthma self-management apps do not combine what is known about evidence-based behavior change strategies and adaptive intervention technologies that tailor the experience based on user data. Our team recently developed Responsive Asthma Care for Teens (ReACT; R56 HL141394), a technological ecosystem including a smartphone app, mobile sensors to assess medication dosing, a Smarthub to achieve real-time data listening, and cloud-based intervention delivery algorithms. ReACT provides personalized and adaptive self-regulatory support to improve asthma self-management via goal-setting, feedback, and barrier identification with problem-solving skills. Results of our pilot work demonstrated that ReACT was acceptable and produced post-intervention changes in our hypothesized mechanisms of self-regulation and problem- solving skills. The proposed study will optimize ReACT based on lessons learned from our pilot work and updated national asthma guidelines. We will conduct an unbalanced (2:1) randomized pilot trial to examine feasibility of our multisite trial protocol, determine if ReACT produces a clinically significant effect on proximal mechanisms hypothesized to drive asthma control, and explore the impact of ReACT on asthma control and asthma-related quality of life. Adolescents ages 13-17 with suboptimal asthma control (n=120) will be randomized to ReACT or a mHealth control condition stratified by regimen for 6-months. Adolescents in the control condition will receive an app that includes static asthma education information and a form for recording symptoms and adherence. The control condition is designed to mirror standard of care, optimize recruitment, and sustain interest while concurrently having a minimal impact on asthma management. Assessments will occur at baseline, 3-month, and post-intervention (6-month) time points. Mechanisms of intervention effect will be collected via both self-report (e.g., self-regulation) and objective (e.g., medication adherence) assessments. We will assess planned future clinical trial outcomes (e.g., asthma control and asthma-related quality of life) to provide effect size estimates for future work. We will have the necessary and sufficient information about the feasibility of our multisite clinical trial protocol and planned analyses at the end of this project.

项目摘要 哮喘影响美国9％的青少年，是青年发病率的主要原因。国家的 哮喘指南强调哮喘自我管理行为控制哮喘和 促进生活质量。青少年对哮喘自我管理行为的屈服 通过欠发达且高度可变的能力来自我调节的认知，情感和行为；和 父母支持的规范减少，而多个需求正在增加。每个青少年经历 对他们在不同时刻进行自我调节的能力的不同威胁，需要个性化和 适应性自我调节性支持以增加日常自我管理行为并实现持续的哮喘 控制。智能手机是改善青少年依从性的最佳机制，但是现有 哮喘自我管理应用程序不结合有关循证行为改变的知识 策略和自适应干预技术根据用户数据量身定制经验。我们的团队 最近针对青少年发展了反应灵敏的哮喘护理（React; R56 HL141394），这是一个技术生态系统 包括智能手机应用程序，用于评估药物给药的移动传感器，可实现实时的智能 数据聆听和基于云的干预量算法。 React提供个性化和适应性 通过目标设定，反馈和障碍提高哮喘自我管理的自我调节支持 通过解决问题的技能识别。我们的飞行员工作的结果表明，反应是可以接受的 并在我们假设的自我调节机制和问题 - 解决技能。拟议的研究将根据从我们的飞行员工作中学到的教训来优化反应， 更新了国家哮喘指南。我们将进行一项不平衡（2：1）随机试验试验以检查 我们的多站点试验方案的可行性，确定反应是否对近端产生显着影响 假设可以驱动哮喘控制的机制，并探索反应对哮喘控制和 与哮喘相关的生活质量。具有次优哮喘控制（n = 120）的13-17岁的青少年将是 随机分配反应或通过治疗疗法分层的6个月的MHealth控制条件。青少年 控制条件将接收一个应用程序，其中包括静态哮喘教育信息和用于记录的表格 症状和依从性。控制条件旨在反映护理标准，优化招聘， 并维持兴趣，同时对哮喘管理产生最小的影响。评估将 发生在基线，3个月和干预后（6个月）时间点。干预效果的机制将 可以通过自我报告（例如自我调节）和客观（例如药物依从性）评估来收集。 我们将评估计划的未来临床试验结果（例如，哮喘控制和与哮喘相关的生活质量） 为将来的工作提供效果大小的估计。我们将拥有有关 我们的多站点临床试验方案的可行性并计划在该项目结束时进行分析。