Silberman Jordan, Sarlati Siavash, Harris Bronwyn, Bokhari Warris, Boushey Homer, Chesnutt Asha, Zhu Peter, Sitts Kelly, Taylor Thomas H, Willey Vincent J, Fuentes Emmanuel, LeKrey Matthew, Hou Evan, Kaur Manpreet, Niyonkuru Christian, Muscioni Guido, Bianchi Matt T, Bota Daniela A, Lee Richard A
Carelon Digital Platforms, Elevance Health, Palo Alto, CA, USA.
Carelon Digital Platforms, Elevance Health, Palo Alto, CA, USA; Department of Emergency Medicine, School of Medicine, University of California, San Francisco, USA.
Contemp Clin Trials. 2022 Nov;122:106902. doi: 10.1016/j.cct.2022.106902. Epub 2022 Aug 30.
Asthma self-management can improve symptom control, but adherence to established self-management behaviors is often poor. With adult asthma uncontrolled in over 60% of U.S. cases, there is a need for scalable, cost-effective tools to improve asthma outcomes. Here we describe a protocol for the Asthma Digital Study, a 24-month, decentralized, pragmatic, open-label, randomized controlled trial investigating the impact of a digital asthma self-management (DASM) program on asthma outcomes in adults. The program leverages consumer-grade devices with a smartphone app to provide "smart nudges," symptom logging, trigger tracking, and other features. Participants are recruited (target N = 900) from throughout the U.S., and randomized to a DASM or control arm (1:1). Co-primary outcomes at one year are a) asthma-associated costs for acute care and b) change from baseline in Asthma Control Test™ scores. Findings may inform decisions around adoption of digital tools for asthma self-management. Trial registration:clinicaltrials.gov identifier: NCT04609644. Registered: Oct 30, 2020.
哮喘自我管理可改善症状控制，但对既定自我管理行为的依从性往往较差。在美国，超过60%的成人哮喘病例未得到有效控制，因此需要可扩展且具成本效益的工具来改善哮喘治疗效果。在此，我们描述一项哮喘数字研究方案，这是一项为期24个月、去中心化、务实、开放标签的随机对照试验，旨在研究数字哮喘自我管理（DASM）计划对成人哮喘治疗效果的影响。该计划利用消费级设备与智能手机应用程序，提供“智能提醒”、症状记录、触发因素追踪及其他功能。研究对象从美国各地招募（目标样本量N = 900），并随机分为DASM组或对照组（1:1）。一年时的共同主要结局指标为：a）急性护理的哮喘相关费用；b）哮喘控制测试™ 分数相对于基线的变化。研究结果可能为围绕采用数字工具进行哮喘自我管理的决策提供参考。试验注册：clinicaltrials.gov标识符：NCT04609644。注册时间：2020年10月30日。
