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

Mobile Health Intervention for Rural Atrial Fibrillation

Sponsors

Lead Sponsor: University of Pittsburgh

Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
Northeastern University
Boston University

Source University of Pittsburgh
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 a smartphone-based intervention called 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 control. Intervention participants will receive 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 AliveCor Kardia for heart rate and rhythm monitoring, an FDA-approved, widely used instrument that pairs with the relational agent. Control participants will receive a smartphone with as well, which will have the health application 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.

Overall Status Recruiting
Start Date 2020-01-08
Completion Date 2023-08-31
Primary Completion Date 2022-12-31
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Medication possession ratio 12 months
Secondary Outcome
Measure Time Frame
Self-reported adherence 4, 8 and 12 months
Change from baseline Atrial Fibrillation Effect on QualiTy of life (AFEQT) at 4, 8 and 12 months Baseline, 4, 8 and 12 months
Emergency room visits 4, 8 and 12 months
Urgent care visits 4, 8 and 12 months
Days of hospitalization 4, 8 and 12 months
Enrollment 264
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Relational agent/AliveCor Kardia - Intervention Group

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

Arm Group Label: Intervention arm

Intervention Type: Behavioral

Intervention Name: Usual Care

Description: Use of the WebMD app daily for 120 days.

Arm Group Label: Usual care arm

Eligibility

Criteria:

Inclusion Criteria: 1. Adult, age ≥18; 2. Diagnosis of AF, identified from the 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. CHA2DS2-VASc (heart failure, hypertension, age, diabetes, prior stroke/TIA, CD, female sex)≥2; 4. Prescribed use of warfarin or DOAC (formerly NOAC) for AF stroke prevention; 5. English-speaking well enough to participate in informed consent and this study; 6. 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 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.

Gender:

All

Minimum Age:

21 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Jared W. Magnani, MD, MSc Principal Investigator University of Pittsburgh
Overall Contact

Last Name: Eresha F. Bluth, MHA

Phone: 412-383-0855

Email: [email protected]

Location
Facility: Status: Contact: Investigator: University of Pittsburgh Medical Center Eresha F Bluth, MHA 412-383-0855 [email protected] Jared W. Magnani, MD, MSc Principal Investigator
Location Countries

United States

Verification Date

2021-01-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Pittsburgh

Investigator Full Name: Jared W Magnani, MD, MSc

Investigator Title: Associate Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Intervention arm

Type: Experimental

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

Label: Usual care arm

Type: Active Comparator

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.

Acronym AFibLITT_R
Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Health Services Research

Masking: Single (Outcomes Assessor)

Masking Description: Telephone assessors conducting the 8- and 12-month assessments will be masked.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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