Mobile Health intervention for rural atrial fibrillation

心房颤动（AF）是一种非常普遍的病态疾病。抗凝治疗预防血栓栓塞性中风 是AF的首要任务，但患者的依从性具有挑战性， 共同慢性病自我管理（CDSM）是一个公认的计划，以提高自我效能， 改善依从性、生活质量和以患者为中心的健康结果。有房颤经历的农村患者 由于地理和社会隔离，医疗保健服务差， 和有限的卫生知识。我们提出了一种创新的，可扩展的CDSM干预，以改善抗凝 这项单中心平行组随机临床试验采用了 嵌入式会话代理（ECA）由智能手机交付。我们使用ECA -一台计算机 一种模拟面对面交谈的角色，使用声音、手势和凝视提示来提供 教育，监测和解决问题-改善个人的健康行为和结果 有限的计算机和健康知识。在此，在患者咨询委员会的指导下，我们建议扩大我们的 成功的30天ECA试点，为AF开发了一种新的CDSM计划。我们将ECA与AliveCor相结合 卡尔迪亚智能手机心率和节律监测器。我们实施了为期4个月的CDSM课程，并评估其 持续8个月和12个月。我们的试验随机选取了264名正在接受抗凝治疗的房颤患者 对于中风预防，（1）ECA/卡尔迪亚干预，伴随着提供者对预先指定的 结果;或（2）对照组，包括AF教育课程和具有一般健康状况的智能手机 应用程序（WebMD）。我们的试验利用了匹兹堡大学的临床基础设施， 在宾夕法尼亚州西部的7个乡村诊所招募，这些诊所共享一个共同的电子健康记录。我们的目标 （1）评估ECA/卡尔迪亚干预对抗凝剂依从性的影响， 药物拥有率，电子药丸计数和自我报告。(2)确定干预措施对 考虑干预、住院、急诊和AF成本的医疗保健利用率- 1年随访时的相关程序。(3)确定干预对以患者为中心的 生活质量和症状的结局，通过AF对生活质量的影响（AFEQT）测量， 特定于AF，以及一般患者报告结局测量信息系统-29 Profile， 基线、4个月、8个月和12个月。(4)通过症状检查干预效果的机制 负担，AF分类，健康素养和干预措施的使用。我们还将通过 研究期间的探索性分析农村和与AF相关的结果。预期结果：在这一研究中， 我们将评估一种可扩展的以患者为中心的干预措施，以改善抗凝治疗依从性、健康 慢性AF弱势农村个体的护理利用率和以患者为中心的结局。 如果成功，这种干预可以广泛传播，以改善AF患者的护理。

Atrial fibrillation (AF) is a highly prevalent, morbid condition. Anticoagulation to prevent thromboembolic strokes is a foremost priority in AF but adherence is challenging for patients and lapses in anticoagulation are common. Chronic disease self-management (CDSM) is a recognized program to enhance self-efficacy and improve adherence, quality of life, and patient-centered health outcomes. Rural patients with AF experience increased vulnerability to adverse outcomes due to geographic and social isolation, poor health care access, and limited health literacy. We propose an innovative, scalable CDSM intervention to improve anticoagulation adherence in rural patients with AF. This single-center parallel group randomized clinical trial employs an embodied conversational agent (ECA) delivered by smartphone. We have used the ECA – a computer character that simulates face-to-face conversation using voice, hand gesture and gaze cues to provide education, monitoring and problem-solving – to improve health behaviors and outcomes in individuals with limited computer and health literacy. Here, guided by a patient advisory committee, we propose to expand our successful 30-day ECA pilot to develop a novel CDSM program for AF. We combine the ECA with the AliveCor Kardia smartphone heart rate and rhythm monitor. We implement a 4-month CDSM curriculum and assess its sustainability at 8 and 12 months. Our trial randomizes 264 patients with AF who are receiving anticoagulation for stroke prevention to (1) the ECA/Kardia intervention, accompanied by provider alerts for prespecified results; or (2) the control, consisting of an AF educational session and a smartphone with a general health application (WebMD). Our trial leverages the clinical infrastructure of the University of Pittsburgh across western Pennsylvania by recruiting at 7 rural clinics that share a common electronic health record. Our aims are: (1) To assess the effect of the ECA/Kardia intervention on anticoagulant adherence, as determined by the medication possession ratio, electronic pill count, and self-report. (2) To identify the effect of the intervention on health care utilization accounting for costs of the intervention, hospitalizations, emergency visits, and AF- related procedures at 1-year follow up. (3) To determine the effect of the intervention on the patient-centered outcomes of quality of life and symptoms, as measured by the AF Effect on QualiTy of life (AFEQT) measure, specific to AF, and the general Patient-Reported Outcomes Measurement Information System-29 Profile at baseline, 4, 8 and 12 months. (4) To examine mechanisms for the effect of the intervention by symptom burden, AF classification, health literacy and intervention use. We will additionally follow the cohort through the study period for exploratory analyses of rurality and outcomes associated with AF. Expected Results: In this project we will evaluate a scalable patient-centered intervention to improve anticoagulation adherence, health care utilization and patient-centered outcomes in vulnerable rural individuals with chronic AF. If proven successful, this intervention can be broadly disseminated to improve the care of patients with AF.