NCT04075994

Atrial Fibrillation Health Literacy and Information Technology Trial

A Mobile Relational Agent to Enhance Atrial Fibrillation Self-care

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 243 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized clinical trial to evaluate the effect of a smartphone-based intervention called a relational agent on health outcomes in people with atrial fibrillation. The study will enroll 240 patients who reside in Pittsburgh-area with this condition and will randomize them to the intervention or control. Intervention participants will receive a smartphone with the agent, which simulates conversation. In addition they will receive an AliveCor Kardia for heart rate and rhythm monitoring, an FDA-approved, widely used instrument that pairs with the smartphone. Control participants will receive a smartphone with WebMD, a brochure published by the American Heart Association that describes AF, and an AliveCor Kardia. The intervention will last 4 months and participants will have visits at baseline, 4, 8 and 12 months. The study will evaluate the improvement in quality of life, medical adherence and health care utilization resulting from the intervention.

Conditions

• Atrial Fibrillation
• Familial Atrial Fibrillation
• Arrythmia, Cardiac
• Heart Diseases
• Pathologic Processes

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-01-02
• Primary completion: 2023-04-11
• Completion: 2023-08-01
• First posted: 2019-09-03
• Last updated: 2024-05-30
• Results posted: 2024-05-30

Locations

1 site across 1 country: United States