Center for Clinical Trials & Data Coordination, Division of General Internal Medicine, University of Pittsburgh School of Medicine, United States of America.
Center for Clinical Trials & Data Coordination, Division of General Internal Medicine, University of Pittsburgh School of Medicine, United States of America.
Contemp Clin Trials. 2023 Jan;124:107015. doi: 10.1016/j.cct.2022.107015. Epub 2022 Nov 17.
Atrial fibrillation (AF) is a chronic cardiovascular disease that frequently causes disruptive symptoms, adverse outcomes, and poor health-related quality of life (HRQoL). We have developed a mobile health application for individuals with AF which provides a longitudinal, patient-centered program to improve self-care. The defining feature of the application is the use of a relational agent, which uses synthetic speech accompanied by animation to provide health education, empathic counseling, and monitoring. In the present manuscript we present the design, rationale, and baseline characteristics of participants enrolled in "A Mobile Relational Agent to Enhance Atrial Fibrillation Self-Care Trial," a randomized trial testing the effectiveness the application for urban-dwelling individuals with AF being treated with oral anticoagulation for prevention of thromboembolic ischemic stroke. This is a single-center, parallel-arm randomized trial that assigned patients to the novel application (relational agent) versus a control intervention (WebMD). This ongoing RCT aims to determine the effect of the mobile health application on: (1) anticoagulation adherence; (2) patient-centered outcomes (quality of life and symptoms); and (3) health care utilization. The primary outcome, anticoagulation adherence, will be measured using the proportion of days covered (PDC). The study completed enrollment on April 1, 2022 (final enrollment n = 243 participants) with expected completion date of April 2023. (http://clinicaltrials.gov registration NCT04075994).
心房颤动（AF）是一种慢性心血管疾病，常导致破坏性症状、不良后果和较差的健康相关生活质量（HRQoL）。我们为 AF 患者开发了一款移动健康应用程序，该应用程序提供了一个纵向的、以患者为中心的计划，以改善自我护理。该应用程序的一个显著特点是使用了一个关系代理，它使用合成语音和动画来提供健康教育、同理心咨询和监测。在本手稿中，我们介绍了“使用移动关系代理增强心房颤动自我护理试验”的设计、原理和参与者的基线特征，这是一项随机试验，测试了该应用程序对接受口服抗凝剂预防血栓栓塞性缺血性中风治疗的城市居住的 AF 患者的有效性。这是一项单中心、平行臂随机试验，将患者分配到新应用程序（关系代理）和对照组（WebMD）。这项正在进行的 RCT 旨在确定移动健康应用程序对以下方面的影响：（1）抗凝治疗依从性；（2）以患者为中心的结果（生活质量和症状）；（3）医疗保健利用。主要结果，抗凝治疗依从性，将通过覆盖天数（PDC）的比例来衡量。该研究于 2022 年 4 月 1 日完成了招募（最终招募 n=243 名参与者），预计完成日期为 2023 年 4 月。（http://clinicaltrials.gov 注册 NCT04075994）。
