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

Brief Title

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

Official Title

Mobile Health Intervention for Rural Atrial Fibrillation

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.
    


Study Type

Interventional


Primary Outcome

Medication possession ratio

Secondary Outcome

 Self-reported adherence

Condition

Atrial Fibrillation

Intervention

Relational agent/AliveCor Kardia - Intervention Group

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

264

Start Date

January 8, 2020

Completion Date

August 31, 2023

Primary Completion Date

December 31, 2022

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

Ages

21 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jared W. Magnani, MD, MSc, 412-383-0855, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04076020

Organization ID

STUDY19050386

Secondary IDs

R01HL143010

Responsible Party

Principal Investigator

Study Sponsor

University of Pittsburgh

Collaborators

 National Heart, Lung, and Blood Institute (NHLBI)

Study Sponsor

Jared W. Magnani, MD, MSc, Principal Investigator, University of Pittsburgh


Verification Date

January 2021