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

项目总结 在美国，哮喘影响着9%的青少年，是青少年发病率的主要原因。全国 哮喘指南强调哮喘自我管理行为对控制哮喘的重要性 提升生活质量。青少年对哮喘自我管理行为的依从性不佳 不发达和高度可变的自我调节认知、情绪和行为的能力；以及 父母支持的规范性减少，而多重需求却在增加。每个青春期的经历 在不同的时刻，他们的自我监管能力受到不同的威胁，需要个性化和 适应性自我调节支持，增加日常自我管理行为，实现持续哮喘 控制力。智能手机是提高青少年忠诚度的最佳机制，然而，现有的 哮喘自我管理应用程序不结合已知的循证行为改变 基于用户数据定制体验的策略和自适应干预技术。我们的团队 最近开发的青少年反应性哮喘护理(Reaction；R56 HL141394)，一个技术生态系统 包括一款智能手机应用程序，用于评估药物剂量的移动传感器，一款实现实时的Smarthb 数据监听和基于云的干预交付算法。Reaction提供个性化和自适应 自我调节支持，通过目标设定、反馈和障碍改善哮喘自我管理 具有解决问题的能力。我们的试点工作结果表明，REACT是可以接受的 并在干预后对我们假设的自我调节机制和问题产生了变化- 解决问题的技巧。拟议的研究将根据我们从试点工作中吸取的经验教训来优化反应，并 更新了国家哮喘指南。我们将进行一项非平衡(2：1)的随机试验来检查 我们的多点试验方案的可行性，确定反应是否在临床上对近端产生显著影响 假想推动哮喘控制的机制，并探索反应对哮喘控制和 与哮喘相关的生活质量。13-17岁哮喘控制不佳的青少年(n=120)将 随机反应或按方案分层的mHealth控制条件，为期6个月。中国的青少年 控制条件将收到包含静态哮喘教育信息的应用程序和用于记录的表格 症状和依从性。控制条件旨在反映护理标准，优化招聘， 并保持兴趣，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 通过自我报告(例如，自我调节)和客观(例如，服药依从性)评估收集数据。 我们将评估计划中的未来临床试验结果(例如，哮喘控制和哮喘相关的生活质量)，以 为未来的工作提供效果大小估计。我们将有必要和充分的信息关于 我们的多点临床试验方案的可行性和该项目结束时的计划分析。

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.