Mobile Health intervention for rural atrial fibrillation

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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.