Mobile Health intervention for rural atrial fibrillation

房颤(房颤)是一种非常普遍的病态疾病。预防血栓栓塞性中风的抗凝治疗 是房颤的首要任务，但对患者来说，坚持治疗是一项挑战，抗凝方面的失误 很普通。慢性病自我管理(CDSM)是一项公认的计划，旨在提高自我效能和 提高依从性、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 由于地理和社会隔绝、卫生保健途径不畅、 以及有限的健康素养。我们提出了一种创新的、可扩展的CDSM干预措施来改善抗凝状态 农村房颤患者的依从性。这项单中心平行分组随机临床试验采用了 智能手机提供的嵌入式会话代理(ECA)。我们用的是ECA--一台电脑 使用语音、手势和凝视提示模拟面对面对话的角色 教育、监测和解决问题--改善患者的健康行为和结果 有限的计算机和健康素养。在这里，在一个患者咨询委员会的指导下，我们建议扩大我们的 成功地进行了为期30天的ECA试点，为房颤开发了一种新颖的CDSM计划。我们将ECA与AliveCor相结合 卡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 8个月和12个月的可持续性。我们的试验随机选择了264名接受抗凝治疗的房颤患者 对于卒中预防，(1)ECA/Kardia干预，伴随着提供者对预先指定的 结果；或(2)对照组，由房颤教育课程和具有一般健康的智能手机组成 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 通过在7家共享共同电子健康记录的农村诊所招聘，可以在宾夕法尼亚州西部进行招聘。我们的目标 (1)评估ECA/Kardia干预对抗凝剂依从性的影响，由 药物持有率、电子药片计数和自我报告。(2)确定干预措施对 考虑到干预、住院、急诊和房颤的费用的医疗保健利用情况- 术后1年随访相关程序。(3)确定以患者为中心的干预效果 生活质量和症状的结果，通过房颤对生活质量的影响(AFEQT)衡量， 特定于房颤，以及一般患者报告结果测量信息系统-29配置文件，请访问 基线、4、8和12个月。(4)对症下药干预效果的机制探讨 负担、房颤分类、健康素养和干预使用。此外，我们还将跟踪队列通过 对与房颤相关的农村和结果进行探索性分析的研究阶段。预期结果：在此 我们将评估一种可扩展的以患者为中心的干预措施，以改善抗凝依从性，健康 农村慢性房颤弱势个体的护理利用和以患者为中心的结局。如果经过验证 如果成功，这种干预可以广泛传播，以改善房颤患者的护理。

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.