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

Sponsor

University of Pittsburgh (Other)

Overall Status

Recruiting

CT.gov ID

NCT04075994

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH), Northeastern University (Other), Boston University (Other)

240

Enrollment

Location

Arms

50.9

Anticipated Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Familial Atrial Fibrillation Arrythmia, Cardiac Heart Diseases Pathologic Processes	Behavioral: Relational Agent and heart rate and rhythm monitor Behavioral: Usual Care	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

A Mobile Relational Agent to Enhance Atrial Fibrillation Self-care

Actual Study Start Date :

Jan 2, 2020

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Mar 29, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention arm Receive the relational agent coupled with the AliveCor Kardia heart rate and rhythm monitor for 120-day use.	Behavioral: Relational Agent and heart rate and rhythm monitor Use of the Relational Agent and heart rate and rhythm monitor daily for 120 days.
Active Comparator: Usual care arm Receive a brochure on atrial fibrillation, the WebMD app and the AliveCor Kardia heart rate and rhythm monitor for 120-day use.	Behavioral: Usual Care Use of the WebMD app and heart rate and rhythm monitor daily for 120 days.

Arm

Intervention/Treatment

Experimental: Intervention arm

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

Behavioral: Relational Agent and heart rate and rhythm monitor

Use of the Relational Agent and heart rate and rhythm monitor daily for 120 days.

Active Comparator: Usual care arm

Receive a brochure on atrial fibrillation, the WebMD app and the AliveCor Kardia heart rate and rhythm monitor for 120-day use.

Behavioral: Usual Care

Use of the WebMD app and heart rate and rhythm monitor daily for 120 days.

Outcome Measures

Primary Outcome Measures

Medication possession ratio [12 months]
Medication Possession Ratio (MPR) is obtained from electronic prescription and pharmacy fill data for oral anticoagulation. MPR is calculated as a percentage (0 to 100%) accounting for days of prescription and date of fill. MPR quantification accounts for days of hospitalization, switching to an alternative anticoagulant agent, and prescribing changes during 12-month follow-up.

Secondary Outcome Measures

Self-reported adherence [Baseline, 4, 8 and 12 months]
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.
Change from baseline Atrial Fibrillation Effect on QualiTy of life (AFEQT) at 4, 8 and 12 months [Baseline, 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.
Emergency room visits [4, 8 and 12 months]
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.
Urgent care visits [4, 8 and 12 months]
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.
Days of hospitalization [4, 8 and 12 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult, age ≥21;
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);
CHA2DS2-VASc (heart failure, hypertension, age, diabetes, prior stroke/TIA, CD, female sex)≥2;
Prescribed use of warfarin or DOAC (formerly NOAC) for AF stroke prevention;
English-speaking well enough to participate in informed consent and this study;
No plans to relocate from the area within 12 months of enrollment.

Exclusion Criteria:

Conditions other than AF that require anticoagulation, such as mechanical prosthetic valve, deep vein thrombosis, or pulmonary embolism;
History of pulmonary vein isolation or foreseen pulmonary vein isolation;
History of AV nodal ablation or foreseen AV nodal ablation;
Heart failure necessitating hospital admission ≤3 months prior to study inclusion;
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;
Untreated hyperthyroidism or ≤3 months euthyroidism before inclusion;
Foreseen pacemaker, internal cardioverter defibrillator, or cardiac resynchronization therapy;
Cardiac surgery ≤3 months before inclusion;
Planned cardiac surgery;
Presence of non-cardiovascular conditions likely to be fatal within 12 months (e.g., cancer);
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.