NCT04076020

Atrial Fibrillation Health Literacy and Information Technology Trial in Rural Pennsylvania Counties

Mobile Health Intervention for Rural Atrial Fibrillation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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. This study uses an innovative, scalable CDSM intervention to improve anticoagulation adherence in rural patients with AF.

Detailed description

This is a randomized clinical trial to evaluate the effect of an embodied conversational agent (ECA) on health outcomes in people with atrial fibrillation. The study will enroll 264 patients who reside in rural, Western Pennsylvania who have atrial fibrillation. Participants will be randomized to the intervention or usual care. Intervention participants will receive a contemporary mobile phone, commonly known and referred to herein as a smartphone, with a relational agent, which simulates conversation and provides coaching, guidance, and assistance with chronic disease self-management. In addition participants will receive an FDA-approved instrument for heart rate and rhythm monitoring, which is named the "AliveCor KardiaMobile" device (herein referred to as the AliveCor Kardia), that pairs with the relational agent. Usual care participants will receive a smartphone as well, which will have the general health application called "WebMD." 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 adherence to anticoagulation, quality of life, and health care utilization resulting from the intervention.

Conditions

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

Interventions

Type	Name	Description
BEHAVIORAL	Relational agent/AliveCor Kardia - Intervention	Use of the relational agent and Kardia daily for 120 days.
BEHAVIORAL	Usual Care	Use of the WebMD app daily for 120 days.

Timeline

• Start date: 2020-01-08
• Primary completion: 2023-05-27
• Completion: 2023-08-02
• First posted: 2019-09-03
• Last updated: 2024-05-30
• Results posted: 2024-05-30

Locations

1 site across 1 country: United States