Atrial Fibrillation Health Literacy and Information Technology Trial

Atrial Fibrillation Clinical Trial

— AFibLITT  

Official title:

A Mobile Relational Agent to Enhance Atrial Fibrillation Self-care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04075994
• Other study ID #: STUDY18110147
• Secondary ID: R61HL144669
• Status: Completed
• Phase: N/A
• Start date: January 2, 2020
• Est. completion date: August 1, 2023

Study information

• Verified date: May 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 American Heart Association 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: August 1, 2023
• Est. primary completion date: April 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Adult, age =21;

2. Diagnosis of AF, identified from the electronic health record problem list and confirmed by 2 or more reports of AF from separate monitoring events at least 2 weeks apart (electrocardiogram, Holter or event monitor);

3. CHA2DS2-VASc (heart failure, hypertension, age, diabetes, prior stroke or transient ischemic attack, coronary heart disease, female sex)=2;

4. Prescribed use of warfarin or direct-acting oral anticoagulant 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 atrioventricular nodal ablation or foreseen atrioventricular 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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Arrythmia, Cardiac
• Atrial Fibrillation
• Familial Atrial Fibrillation
• Heart Diseases
• Pathologic Processes

Intervention

Behavioral:
• Relational Agent and heart rate and rhythm monitor
Use of the Relational Agent and heart rate and rhythm monitor daily for 120 days.
• Usual Care
Use of the WebMD app and heart rate and rhythm monitor daily for 120 days.

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
University of Pittsburgh	Boston University, National Heart, Lung, and Blood Institute (NHLBI), Northeastern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Days Covered	Proportion of Days Covered (PDC), obtained from collection of electronic prescription and pharmacy fill data, and defined as the proportion of availability of medication for the period of interest, here the period from the date of the baseline to the 12-month examination. PDC range is 0 to 1.00 with higher values indicating greater proportion of days with medication over the 12-month period of study participation as indicated by pharmacy records.	12 months
Secondary	Self-reported Non-adherence	Self-reported non-adherence to oral anticoagulation with a 3-item instrument with each item scored 1-5 and lower scores indicating adherence. Scores dichotomized to classify participants as adherent (indicated by reporting 1 on all 3 items) or as non-adherent (indicated by reporting = 2 on any of the 3 items).	4, 8 and 12 months
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS)-29	Measure Description: Patient-Reported Outcomes Measurement Information System (PROMIS)-29 assesses 7 domains (physical function; depression and sadness; pain interference; satisfaction with participation in social roles and activities; fatigue; anxiety and fear; sleep disturbance), 4 questions each, and Pain Intensity with a single item. The 7 domain scores are transformed using a T-score with a mean of 50, standard deviation of 10, in a referent population. Higher scores indicate worse health for the depression, pain, fatigue, anxiety/sleep domains, while higher scores indicate better health for the physical function and satisfaction domains. The single Pain Intensity item is scored 0 (No pain) to 10 (Worst imaginable pain) in the past 7 days.; Further details on PROMIS scoring are available at https://www.healthmeasures.net/images/PROMIS/manuals/PROMIS_Adult_Profile_Scoring_Manual.pdf.	4, 8, and 12 months
Secondary	Atrial Fibrillation Effect on Quality of Life (AFEQT)	The Atrial Fibrillation Effect on Quality of life (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.	4, 8 and 12 months
Secondary	Emergency Room (ER) Visits and Hospitalizations	The number of emergency room visits and hospitalizations quantified at 12 months.	12 months
Secondary	Days of Hospitalization	The number of days of hospitalization ascertained from extraction of electronic health records through the 12 months of study duration. Total days spent in hospital over 12 months were summarized as a single count for each participant.	12 months