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

NCT ID: NCT04076020

Last Updated: 2024-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-08
• Study Completion Date: 2023-08-02

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention

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

Group Type: EXPERIMENTAL

Relational agent/AliveCor Kardia - Intervention

Intervention Type: BEHAVIORAL

Use of the relational agent and Kardia daily for 120 days.

Usual Care

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.

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: BEHAVIORAL

Use of the WebMD app daily for 120 days.

Interventions

Relational agent/AliveCor Kardia - Intervention

Use of the relational agent and Kardia daily for 120 days.

Intervention Type: BEHAVIORAL

Usual Care

Use of the WebMD app daily for 120 days.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Northeastern University

OTHER

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Jared W Magnani, MD, MSc

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jared W. Magnani, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Countries

United States

References

Mann HK, Streiff M, Schultz KC, Halpern DV, Ferry D, Johnson AE, Magnani JW. Rurality and Atrial Fibrillation: Patient Perceptions of Barriers and Facilitators to Care. J Am Heart Assoc. 2023 Nov 7;12(21):e031152. doi: 10.1161/JAHA.123.031152. Epub 2023 Oct 27.

Reference Type: DERIVED

PMID: 37889198 (View on PubMed)

Palmer MJ, Machiyama K, Woodd S, Gubijev A, Barnard S, Russell S, Perel P, Free C. Mobile phone-based interventions for improving adherence to medication prescribed for the primary prevention of cardiovascular disease in adults. Cochrane Database Syst Rev. 2021 Mar 26;3(3):CD012675. doi: 10.1002/14651858.CD012675.pub3.

Reference Type: DERIVED

PMID: 33769555 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R01HL143010

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY19050386

Identifier Type: -

Identifier Source: org_study_id