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

Mobile Health Intervention for Rural Atrial Fibrillation

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.

Study Overview

• Status: Completed
• Conditions: Pathologic Processes; Heart Diseases; Atrial Fibrillation; Arrhythmia, Cardiac; Familial Atrial Fibrillation
• Intervention / Treatment: Behavioral: Relational agent/AliveCor Kardia - Intervention Group; Behavioral: Usual Care

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
• Enrollment (Actual): 270
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; Receive the relational agent and the AliveCor Kardia for use for 120 days. Participants are directed to use these interventions daily.	Behavioral: Relational agent/AliveCor Kardia - Intervention Group; Use of the relational agent and Kardia daily for 120 days.
Active Comparator: Usual care arm; 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.	Behavioral: Usual Care; Use of the WebMD app daily for 120 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Days Covered	Proportion of Days Covered (PDC) is obtained from electronic prescription and pharmacy fill data for oral anticoagulation. PDC is calculated as a percentage (0 to 100%) accounting for days of prescription and date of fill. PDC quantification accounts for days of hospitalization, switching to an alternative anticoagulant agent, and prescribing changes during 12-month follow-up.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported adherence	A three-item instrument to ascertain self-reported non-adherence. Items are scored with a Likert scale from 0 ("None fo the time.") to 5 ("Every time."). The score is scaled as a continuous measure (0 to 15) and dichotomous categorization.	4, 8 and 12 months
Change from baseline Atrial Fibrillation Effect on QualiTy of life (AFEQT) at 4, 8 and 12 months	The AFEQT is a widely used measure of atrial fibrillation-specific health-related quality of life. Scores range from 0 to 100 with higher scores indicating superior health-related quality of life in AF. The AFEQT measure consists of a global score and 4 domains (symptoms, daily activities, treatment concerns, and treatment satisfaction). We prioritize the global score because of its specificity to AF, our experience with this measure in our preliminary and pilot studies, extensive validation, and ease of administration. The AFEQT subdomains (symptoms, daily activities, treatment concerns, and treatment satisfaction) constitute secondary outcomes.	Baseline, 4, 8 and 12 months
Emergency room visits	The number of emergency room visits will be quantified at 4, 8 and 12 months. These data will be used to compare health care utilization between the two study arms.	4, 8 and 12 months
Urgent care visits	The number of urgent care visits will be quantified at 4, 8 and 12 months. These data will be used to compare health care utilization between the two study arms.	4, 8 and 12 months
Days of hospitalization	The number of days of hospitalization will be quantified at 4, 8 and 12 months. These data will be used to compare health care utilization between the two study arms.	4, 8 and 12 months

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Boston University; National Heart, Lung, and Blood Institute (NHLBI); Northeastern University
• Investigators: Principal Investigator: Jared W. Magnani, MD, MSc, University of Pittsburgh

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2020
• Primary Completion (Actual): May 27, 2023
• Study Completion (Actual): August 2, 2023

Study Registration Dates

• First Submitted: August 28, 2019
• First Submitted That Met QC Criteria: August 29, 2019
• First Posted (Actual): September 3, 2019

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Adherence; quality of life; Health Literacy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Atrial Fibrillation; Arrhythmias, Cardiac; Pathologic Processes
• Other Study ID Numbers: STUDY19050386; R01HL143010 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study team will share individual participant data that underlie the results reported in the study's central manuscripts after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Such data will be available beginning 9 months and ending 36 months following publication of the main manuscripts resulting from this clinical trial.
• IPD Sharing Access Criteria: Data will be made available to those investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Proposals may be submitted up to 36 months following article publication. Applicants requesting access to the data will be responsible for the minimal administrative costs to provide the data set.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No