Atrial FibrillationAFibLITT_RNCT04076020

Atrial Fibrillation Health Literacy and Information Technology Trial in Rural Pennsylvania Counties

A study testing Relational agent/AliveCor Kardia - Intervention 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, Arrhythmia, Cardiac
What is being tested?: Relational agent/AliveCor Kardia - Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 270 participants
Where: 1 siteUnited States
Study dates: 8 Jan 2020to 2 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 (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);
Prescribed use of warfarin or direct-acting oral anticoagulant (DOAC) 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 (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;

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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: 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.

Read the detailed description

This is a randomized clinical trial to evaluate the effect of 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 usual care. Intervention participants will receive a contemporary mobile phone, commonly known and referred to herein as 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 FDA-approved instrument for heart rate and rhythm monitoring, which is named the "AliveCor KardiaMobile" device (herein referred to as the AliveCor Kardia), that pairs with the relational agent. Usual care participants will receive a smartphone as well, which will have the general health application called "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.

Conditions: Atrial Fibrillation, Familial Atrial Fibrillation, Arrhythmia, Cardiac, Heart Diseases, Pathologic Processes
Being tested: Relational agent/AliveCor Kardia - Intervention, Usual Care
Keywords: Adherence, Health Literacy, quality of life
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/AliveCor Kardia - InterventionBehavioural
Use of the relational agent and Kardia daily for 120 days.
Usual CareBehavioural
Use of the WebMD app daily for 120 days.

Study groups in NCT04076020
Study group	Role	What they receive
Intervention	Experimental	Receive the relational agent and the AliveCor Kardia for use for 120 days. Participants are directed to use these interventions daily. Receives: Behavioral: Relational agent/AliveCor Kardia - Intervention
Usual Care	Active comparator	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. 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. PDC range is 0 to 1.00 with higher values indicating greater proportion of days with medication as indicated by pharmacy records.
Measured: 12 months
Self-reported Adherence
Self-reported adherence to oral anticoagulation. 3-item instrument with range 1-5 such that lower scores indicate more frequent medication adherence. Here the score is dichotomized by classifying participants reporting 1 for all three items as adherent and those that reported ≥ 2 on any item as non-adherent.
Measured: 4, 8, and 12 months

Secondary outcomes (4)

Atrial Fibrillation Effect on Quality of Life (AFEQT)
The AFEQT is a widely used measure of atrial fibrillation-specific health-related quality of life which consists of a global score and 4 domains (symptoms, daily activities, treatment concerns, and treatment satisfaction). Overall or subscale scores range from 0-100 with higher scores indicating superior health-related quality of life in AF. A score of 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered).
Measured: 4, 8, and 12 months
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
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
Emergency Room Visits
The number of participants with 1 or more emergency room visits will be quantified at 12 months. Data will be used to compare health care utilization between the two study arms.
Measured: 12 months
Hospital Admissions
The number of participants with one or more hospitalization will be quantified at 12 months. Data will be used to compare health care utilization between the two study arms.
Measured: 12 months

Timeline

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

8 Jan 20202 Aug 2023

First posted3 Sep 2019
Study start8 Jan 2020
Primary completion27 May 2023
Study completion2 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: 270 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04076020
Sponsor's protocol ID: STUDY19050386
Other IDs: R01HL143010
Acronym: AFibLITT_R
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

Mann HK, Streiff M, Schultz KC, Halpern DV, Ferry D, Johnson AE, Magnani JW. Rurality and Atrial Fibrillation: Patient Perceptions of Barriers and Facilitators to Care. J Am Heart Assoc. 2023 Nov 7;12(21):e031152. doi: 10.1161/JAHA.123.031152. Epub 2023 Oct 27.
PubMed 37889198
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.
PubMed 33769555

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: Mobile Health Intervention for Rural Atrial Fibrillation
ClinicalTrials.gov ID: NCT04076020
Acronym / sponsor ID: AFibLITT_R / STUDY19050386
Conditions: Atrial Fibrillation, Familial Atrial Fibrillation, Arrhythmia, Cardiac, Heart Diseases, Pathologic Processes
Keywords: Adherence, Health Literacy, quality of life
Study type: Interventional
Recruitment status: Completed
Enrolment: 270 participants (actual)
Lead sponsor: University of PittsburghUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), Northeastern University, Boston University
Study start: 8 Jan 2020 (actual)
Primary completion: 27 May 2023 (actual)
Study completion: 2 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	Experimental	Behavioral: Relational agent/AliveCor Kardia - InterventionReceive the relational agent and the AliveCor Kardia for use for 120 days. Participants are directed to use these interventions daily.
Usual Care	Active comparator	Behavioral: Usual CareReceive 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.

Who may qualify

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

Key inclusion criteria (5 listed)

Adult, age ≥21;
Diagnosis of AF, identified from the electronic health record (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);
Prescribed use of warfarin or direct-acting oral anticoagulant (DOAC) 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.

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 (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;

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/AliveCor Kardia - InterventionUse of the relational agent and Kardia daily for 120 days.	Behavioural	Intervention
Usual CareUse of the WebMD app daily for 120 days.	Behavioural	Usual Care

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. PDC range is 0 to 1.00 with higher values indicating greater proportion of days with medication as indicated by pharmacy records.
Self-reported Adherence
Time frame: 4, 8, and 12 months
Self-reported adherence to oral anticoagulation. 3-item instrument with range 1-5 such that lower scores indicate more frequent medication adherence. Here the score is dichotomized by classifying participants reporting 1 for all three items as adherent and those that reported ≥ 2 on any item as non-adherent.

4 secondary outcomes

Atrial Fibrillation Effect on Quality of Life (AFEQT)
Time frame: 4, 8, and 12 months
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Time frame: 4, 8, and 12 months
Emergency Room Visits
Time frame: 12 months
Hospital Admissions
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: ECA/Kardia	135	119
Control: WebMD	135	121

Primary outcome: Proportion of Days Covered

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

Measure	Intervention n = 124	Usual Care n = 126
Value	.97 (0.89 to 1.00)	0.97 (0.92 to 1.00)

Intervention vs Usual Care: p = 0.99, Wilcoxon (Mann-Whitney)
Intervention vs Usual Care: p <0.05, Regression, Logistic

Population analysed: Initial data set included 270 participants. 7 cases of no pharmacy data, 12 cases with start date after end date, and 1 case where one fill was available before randomization. PDC was calculated for 250 participants.

Primary outcome: Self-reported Adherence

Time frame: 4, 8, and 12 months. Count of participants. Unit: Participants

Measure	Intervention n = 135	Usual Care n = 135
Adherence-4 Months: Adherent	112	107
Adherence-4 Months: Non-adherent	5	14
Adherence-8 Months: Adherent	106	93
Adherence-8 Months: Non-adherent	8	25
Adherence-12 Months: Adherent	104	98
Adherence-12 Months: Non-adherent	10	17

Intervention vs Usual Care: p <0.05, Regression, Logistic

Population analysed: Intervention 4-month: n=117 (11 withdrawals \[w/d\], 1 death; 4 discontinued \[d/c\] oral anticoagulation \[OAC\]; 2 missed visit) 8-month: n=114 (total 12 w/d, 4 deaths; 3 d/c OAC; 2 missed visit) 12-month: n=114 (total 12 w/d, 4 deaths, 5 d/c OAC) Control 4-month: n=121 (8 w/d, 4 deaths; 1 d/c OAC; 1 missed visit) 8-month: n=118 (total 8 w/d, 6 deaths; 3 d/c OAC) 12-month: n=115 (total 8 w/d, 6 deaths; 4 d/c OAC; 2 missed visit)

4 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	35 of 135 (25.9%)	32 of 135 (23.7%)	4 of 135
Usual Care	31 of 135 (23%)	40 of 135 (29.6%)	6 of 135

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 37889198Mann HK, Streiff M, Schultz KC, Halpern DV, Ferry D, Johnson AE, Magnani JW. Rurality and Atrial Fibrillation: Patient Perceptions of Barriers and Facilitators to Care. J Am Heart Assoc. 2023 Nov 7;12(21):e031152. doi: 10.1161/JAHA.123.031152. Epub 2023 Oct 27.
Derived from this study: PubMed 33769555Palmer 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.
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/AliveCor Kardia - Intervention 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 5 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). The study lists 2 primary outcomes in all. 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 NCT04076020, 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.