Atrial Fibrillation Health Literacy and Information Technology Trial in Pittsburgh, PA

Brief Title

Atrial Fibrillation Health Literacy and Information Technology Trial in Pittsburgh, PA

Official Title

A Mobile Relational Agent to Enhance Atrial Fibrillation Self-care

Brief Summary

      Atrial fibrillation (AF) is a common, morbid condition with increasing prevalence. Poor
      health-related quality of life is common in AF. Patients experience debilitating symptoms and
      challenging adherence to long-term (possibly lifelong) anticoagulation. The increased risks
      of stroke, heart failure and mortality associated with AF persist even with optimal
      treatment. Morbidity in AF is further exacerbated by social factors. Limited health literacy
      carries challenges of learning a specialized terminology and navigating specialized
      treatments. In multiple cardiovascular diseases, self-care has demonstrated improvement in
      self-efficacy, health-related quality of life, symptom burden, and health care utilization -
      essential components of patient success with AF. Selfcare can provide the critical skills to
      navigate a challenging chronic disease and improve patient-centered outcomes. Delivery of
      self-care as a mobile health intervention can complement standard care with a longitudinal
      intervention to improve patient-centered strategies for AF. While self-care interventions for
      AF have focused foremost on self-monitoring of anticoagulation,self-care has demonstrated its
      potential to meet the "triple aim" of improved patient experience, reduced health care
      utilization, and lower costs.
    

Detailed Description

      This is a randomized clinical trial to evaluate the effect of a smartphone-based intervention
      called a relational agent on health outcomes in people with atrial fibrillation. The study
      will enroll 240 patients who reside in Pittsburgh-area with this condition and will randomize
      them to the intervention or control. Intervention participants will receive a smartphone with
      the agent, which simulates conversation. In addition they will receive an AliveCor Kardia for
      heart rate and rhythm monitoring, an FDA-approved, widely used instrument that pairs with the
      smartphone. Control participants will receive a smartphone with WebMD, a brochure published
      by the AHA that describes AF, and an AliveCor Kardia. 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 quality of life, medical adherence 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 and heart rate and rhythm monitor

Study Arms / Comparison Groups

 Intervention arm
Description:  Receive the relational agent coupled with the AliveCor Kardia heart rate and rhythm monitor for 120-day use.

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

240

Start Date

January 2, 2020

Completion Date

March 29, 2024

Primary Completion Date

September 1, 2023

Eligibility Criteria

        Inclusion Criteria:

          1. Adult, age ≥21;

          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

NCT04075994

Organization ID

STUDY18110147

Secondary IDs

R61HL144669

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