Design, rationale, and baseline characteristics of a randomized controlled trial evaluating a mobile relational agent to enhance atrial fibrillation self-care.
Design, rationale, and baseline characteristics of a randomized controlled trial evaluating a mobile relational agent to enhance atrial fibrillation self-care.
复制标题
一项随机对照试验的设计、原理和基线特征，该试验评估移动关系代理以增强房颤自我护理。
DOI：
10.1016/j.cct.2022.107015
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发表时间：
2023
影响因子：
2.2
通讯作者：
Magnani,JaredW
中科院分区：
文献类型：
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作者：
Althouse,AndrewD;Abebe,KaleabZ;Paasche-Orlow,MichaelK;Lalama,ChristinaM;Ferry,Danielle;Lancet,Michelle;Swabe,Gretchen;Bickmore,Timothy;Magnani,JaredW
心房颤动（AF）是一种慢性心血管疾病，经常引起破坏性症状、不良后果和较差的健康相关生活质量（HRQoL）。我们为房颤患者开发了一个移动健康应用程序，它提供了一个纵向的、以患者为中心的项目来改善自我保健。该应用程序的定义特征是使用关系代理，它使用伴随着动画的合成语音来提供健康教育、移情咨询和监测。在本文中，我们介绍了“增强房颤自我护理的移动关联剂试验”参与者的设计、基本原理和基线特征，这是一项随机试验，旨在测试城市居民房颤患者口服抗凝治疗预防血栓栓塞性缺血性卒中的有效性。这是一项单中心，平行组随机试验，将患者分配到新应用（关系药物）和对照干预（WebMD）。这项正在进行的随机对照试验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)以患者为中心的结局（生活质量和症状）；(3)卫生保健利用。主要终点抗凝粘附性将使用覆盖天数比例（PDC）来衡量。该研究于2022年4月1日完成入组（最终入组人数为243人），预计完成日期为2023年4月（http://clinicaltrials.gov注册编号NCT04075994）。
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 enrollmentn= 243 participants) with expected completion date of April 2023.(http://clinicaltrials.gov registration NCT04075994)