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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04075994
Recruitment Status : Recruiting
First Posted : September 3, 2019
Last Update Posted : January 6, 2020
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Northeastern University
Boston University
Information provided by (Responsible Party):
Jared W Magnani, MD, MSc, University of Pittsburgh

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 2, 2020
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : March 29, 2024


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.




Primary Outcome Measures :
  1. Medication possession ratio [ Time Frame: 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 :
  1. Self-reported adherence [ Time Frame: 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.

  2. Change from baseline Atrial Fibrillation Effect on QualiTy of life (AFEQT) at 4, 8 and 12 months [ Time Frame: 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.

  3. Emergency room visits [ Time Frame: 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.

  4. Urgent care visits [ Time Frame: 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.

  5. Days of hospitalization [ Time Frame: 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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult, age ≥21;
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04075994


Contacts
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Contact: Eresha F Bluth, MHA 412-383-0855 efb9@pitt.edu

Locations
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United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Eresha F Bluth, MHA    412-383-0855    efb9@pitt.edu   
Principal Investigator: Jared W. Magnani, MD, MSc         
Sponsors and Collaborators
University of Pittsburgh
National Heart, Lung, and Blood Institute (NHLBI)
Northeastern University
Boston University
Investigators
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Principal Investigator: Jared W Magnani, MD, MSc University of Pittsburgh
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Responsible Party: Jared W Magnani, MD, MSc, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04075994    
Other Study ID Numbers: STUDY18110147
R61HL144669 ( U.S. NIH Grant/Contract )
First Posted: September 3, 2019    Key Record Dates
Last Update Posted: January 6, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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).
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
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.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jared W Magnani, MD, MSc, University of Pittsburgh:
Quality of Life (QoL)
Adherence
Health Literacy
Additional relevant MeSH terms:
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Atrial Fibrillation
Heart Diseases
Arrhythmias, Cardiac
Pathologic Processes
Cardiovascular Diseases