Atrial FibrillationAFibLITTNCT04075994

Atrial Fibrillation Health Literacy and Information Technology Trial

A study testing Relational Agent and heart rate and rhythm monitor in people with Atrial Fibrillation and Familial Atrial Fibrillation, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 years and older
Conditions the study is for: Atrial Fibrillation, Familial Atrial Fibrillation, Arrythmia, Cardiac
What is being tested?: Relational Agent and heart rate and rhythm monitor
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 243 participants
Where: 1 siteUnited States
Study dates: 2 Jan 2020to 1 Aug 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult, age ≥21;
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);
CHA2DS2-VASc (heart failure, hypertension, age, diabetes, prior stroke or transient ischemic attack, coronary heart disease, female sex)≥2;
Prescribed use of warfarin or direct-acting oral anticoagulant 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.

Who cannot join

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 atrioventricular nodal ablation or foreseen atrioventricular 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;

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: A Mobile Relational Agent to Enhance Atrial Fibrillation Self-care

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.

Read the 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 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.

Conditions: Atrial Fibrillation, Familial Atrial Fibrillation, Arrythmia, Cardiac, Heart Diseases, Pathologic Processes
Being tested: Relational Agent and heart rate and rhythm monitor, Usual Care
Keywords: Quality of Life (QoL), Adherence, Health Literacy
Medical subject headings: Atrial Fibrillation, Arrhythmias, Cardiac, Heart Diseases, Pathologic Processes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Relational Agent and heart rate and rhythm monitorBehavioural
Use of the Relational Agent and heart rate and rhythm monitor daily for 120 days.
Usual CareBehavioural
Use of the WebMD app and heart rate and rhythm monitor daily for 120 days.

Study groups in NCT04075994
Study group	Role	What they receive
Intervention arm	Experimental	Receive the relational agent coupled with the AliveCor Kardia heart rate and rhythm monitor for 120-day use. Receives: Behavioral: Relational Agent and heart rate and rhythm monitor
Usual care arm	Active comparator	Receive a brochure on atrial fibrillation, the WebMD app and the AliveCor Kardia heart rate and rhythm monitor for 120-day use. Receives: Behavioral: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 months

Secondary outcomes (5)

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).
Measured: 4, 8 and 12 months
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.
Measured: 4, 8, and 12 months
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.
Measured: 4, 8 and 12 months
Emergency Room (ER) Visits and Hospitalizations
The number of emergency room visits and hospitalizations quantified at 12 months.
Measured: 12 months
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.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jan 20201 Aug 2023

First posted3 Sep 2019
Study start2 Jan 2020
Primary completion11 Apr 2023
Study completion1 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Atrial FibrillationStudies of the same condition, open and under way.
More trials run by University of PittsburghThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 243 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04075994
Sponsor's protocol ID: STUDY18110147
Other IDs: R61HL144669
Acronym: AFibLITT
Status last verified: May 2024
First submitted: 28 Aug 2019
Last updated: 30 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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).

Publications

Magnani JW, Lalama CM, Abebe KZ, Ferry D, Rollman BL, Lancet MQ, Kimani E, Olafsson S, Bickmore T, Paasche-Orlow MK. A mobile relational agent to enhance atrial fibrillation self-care: Primary and secondary outcomes of a randomized controlled trial. Am Heart J. 2025 Dec;290:115-128. doi: 10.1016/j.ahj.2025.06.009. Epub 2025 Jun 20.
PubMed 40545207
Althouse AD, Abebe KZ, Paasche-Orlow MK, Lalama CM, Ferry D, Lancet M, Swabe G, Bickmore T, Magnani JW. Design, rationale, and baseline characteristics of a randomized controlled trial evaluating a mobile relational agent to enhance atrial fibrillation self-care. Contemp Clin Trials. 2023 Jan;124:107015. doi: 10.1016/j.cct.2022.107015. Epub 2022 Nov 17.
PubMed 36402276

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Mobile Relational Agent to Enhance Atrial Fibrillation Self-care
ClinicalTrials.gov ID: NCT04075994
Acronym / sponsor ID: AFibLITT / STUDY18110147
Conditions: Atrial Fibrillation, Familial Atrial Fibrillation, Arrythmia, Cardiac, Heart Diseases, Pathologic Processes
Keywords: Quality of Life (QoL), Adherence, Health Literacy
Study type: Interventional
Recruitment status: Completed
Enrolment: 243 participants (actual)
Lead sponsor: University of PittsburghUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), Northeastern University, Boston University
Study start: 2 Jan 2020 (actual)
Primary completion: 11 Apr 2023 (actual)
Study completion: 1 Aug 2023 (actual)
First posted: 3 Sep 2019 (actual)
Results: Posted 30 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intervention arm	Experimental	Behavioral: Relational Agent and heart rate and rhythm monitorReceive the relational agent coupled with the AliveCor Kardia heart rate and rhythm monitor for 120-day use.
Usual care arm	Active comparator	Behavioral: Usual CareReceive a brochure on atrial fibrillation, the WebMD app and the AliveCor Kardia heart rate and rhythm monitor for 120-day use.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Adult, age ≥21;
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);
CHA2DS2-VASc (heart failure, hypertension, age, diabetes, prior stroke or transient ischemic attack, coronary heart disease, female sex)≥2;
Prescribed use of warfarin or direct-acting oral anticoagulant for AF stroke prevention;
English-speaking well enough to participate in informed consent and this study;

Key exclusion criteria (11 listed)

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 atrioventricular nodal ablation or foreseen atrioventricular 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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Relational Agent and heart rate and rhythm monitorUse of the Relational Agent and heart rate and rhythm monitor daily for 120 days.	Behavioural	Intervention arm
Usual CareUse of the WebMD app and heart rate and rhythm monitor daily for 120 days.	Behavioural	Usual care arm

Primary outcome

Proportion of Days Covered
Time frame: 12 months
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.

5 secondary outcomes

Self-reported Non-adherence
Time frame: 4, 8 and 12 months
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Time frame: 4, 8, and 12 months
Atrial Fibrillation Effect on Quality of Life (AFEQT)
Time frame: 4, 8 and 12 months
Emergency Room (ER) Visits and Hospitalizations
Time frame: 12 months
Days of Hospitalization
Time frame: 12 months

Results and safety

Results posted to the registry on 30 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention	123	110
Usual Care	120	108

Primary outcome: Proportion of Days Covered

Time frame: 12 months. Median (Inter-Quartile Range). Unit: Proportion of days covered

Measure	Intervention n = 115	Usual Care n = 113
Value	1.0 (0.9 to 1.0)	0.9 (0.8 to 1.0)

Intervention vs Usual Care: p = 0.22, t-test, 2 sided

Population analysed: Pharmacy data were not available for 8 intervention and 7 usual care participants.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Data collection occurred from date of consent through the participants 12-month visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention	30 of 123 (24.4%)	18 of 123 (14.6%)	2 of 123
Usual Care	26 of 120 (21.7%)	26 of 120 (21.7%)	2 of 120

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40545207Magnani JW, Lalama CM, Abebe KZ, Ferry D, Rollman BL, Lancet MQ, Kimani E, Olafsson S, Bickmore T, Paasche-Orlow MK. A mobile relational agent to enhance atrial fibrillation self-care: Primary and secondary outcomes of a randomized controlled trial. Am Heart J. 2025 Dec;290:115-128. doi: 10.1016/j.ahj.2025.06.009. Epub 2025 Jun 20.
Derived from this study: PubMed 36402276Althouse AD, Abebe KZ, Paasche-Orlow MK, Lalama CM, Ferry D, Lancet M, Swabe G, Bickmore T, Magnani JW. Design, rationale, and baseline characteristics of a randomized controlled trial evaluating a mobile relational agent to enhance atrial fibrillation self-care. Contemp Clin Trials. 2023 Jan;124:107015. doi: 10.1016/j.cct.2022.107015. Epub 2022 Nov 17.
Individual participant dataSharing planned: Yes. 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).

Related trials for Atrial Fibrillation

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jared W Magnani, MD, MSc principal investigator

University of Pittsburgh

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Relational Agent and heart rate and rhythm monitor in people with Atrial Fibrillation and Familial Atrial Fibrillation, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Days Covered (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04075994, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.