Atrial Fibrillation Health Literacy and Information Technology Trial
NCT04075994 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 243
Last updated 2024-05-30
Summary
Atrial fibrillation (AF) is a common, morbid condition with increasing prevalence. Poor health-related quality of life is common in AF. Patients experience debilitating symptoms and challenging adherence to long-term (possibly lifelong) anticoagulation. The increased risks of stroke, heart failure and mortality associated with AF persist even with optimal treatment. Morbidity in AF is further exacerbated by social factors. Limited health literacy carries challenges of learning a specialized terminology and navigating specialized treatments. In multiple cardiovascular diseases, self-care has demonstrated improvement in self-efficacy, health-related quality of life, symptom burden, and health care utilization - essential components of patient success with AF. Selfcare can provide the critical skills to navigate a challenging chronic disease and improve patient-centered outcomes. Delivery of self-care as a mobile health intervention can complement standard care with a longitudinal intervention to improve patient-centered strategies for AF. While self-care interventions for AF have focused foremost on self-monitoring of anticoagulation,self-care has demonstrated its potential to meet the "triple aim" of improved patient experience, reduced health care utilization, and lower costs.
Conditions
- Atrial Fibrillation
- Familial Atrial Fibrillation
- Arrythmia, Cardiac
- Heart Diseases
- Pathologic Processes
Interventions
- BEHAVIORAL
-
Relational Agent and heart rate and rhythm monitor
Use of the Relational Agent and heart rate and rhythm monitor daily for 120 days.
- BEHAVIORAL
-
Usual Care
Use of the WebMD app and heart rate and rhythm monitor daily for 120 days.
Sponsors & Collaborators
-
National Heart, Lung, and Blood Institute (NHLBI)
collaborator NIH -
Northeastern University
collaborator OTHER -
Boston University
collaborator OTHER -
University of Pittsburgh
lead OTHER
Principal Investigators
-
Jared W Magnani, MD, MSc · University of Pittsburgh
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-01-02
- Primary Completion
- 2023-04-11
- Completion
- 2023-08-01
Countries
- United States
Study Locations
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