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

University of Pittsburgh

Status: Completed

Conditions: Atrial Fibrillation; Familial Atrial Fibrillation; Arrhythmia, Cardiac; Heart Diseases; Pathologic Processes

Treatments: Behavioral: Relational agent/AliveCor Kardia - Intervention; Behavioral: Usual Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04076020

STUDY19050386

R01HL143010 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 270 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult, age ≥21;
2. Diagnosis of AF, identified from the electronic health record (EHR) problem list and confirmed by 2 or more reports of AF from separate monitoring events at least 2 weeks apart (CG, Holter or event monitor);
3. Prescribed use of warfarin or direct-acting oral anticoagulant (DOAC) for AF stroke prevention;
4. English-speaking well enough to participate in informed consent and this study;
5. No plans to relocate from the area within 12 months of enrollment.

Exclusion criteria

1. Conditions other than AF that require anticoagulation, such as mechanical prosthetic valve, deep vein thrombosis, or pulmonary embolism;
2. History of pulmonary vein isolation or foreseen pulmonary vein isolation;
3. History of atrioventricular (AV) nodal ablation or foreseen AV nodal ablation;
4. Heart failure necessitating hospital admission ≤3 months prior to study inclusion;
5. Acute coronary syndrome (defined as at least 2 of the following: chest pain, ischemic electrocardiographic changes, or troponin ≥0.1 ng/mL) ≤3 months prior to study inclusion;
6. Untreated hyperthyroidism or ≤3 months euthyroidism before inclusion;
7. Foreseen pacemaker, internal cardioverter defibrillator, or cardiac resynchronization therapy;
8. Cardiac surgery ≤3 months before inclusion;
9. Planned cardiac surgery;
10. Presence of non-cardiovascular conditions likely to be fatal within 12 months (e.g., cancer);
11. Inability to comprehend the study protocol, defined as failing to answer correctly a set of questions on orientation and short-term memory during the consent process.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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270 participants in 2 patient groups

Intervention

Experimental group

Description:

Receive the relational agent and the AliveCor Kardia for use for 120 days. Participants are directed to use these interventions daily.

Treatment:

Behavioral: Relational agent/AliveCor Kardia - Intervention

Usual Care

Active Comparator group

Description:

Receive a brochure on atrial fibrillation that is published by the American Heart Association and a smartphone with the WebMD application. Participants are directed to use the WebMD application as often as they would like.

Treatment:

Behavioral: Usual Care