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Trial record 1 of 1 for:    NCT02731326
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iPhone Helping Evaluate Atrial Fibrillation Rhythm Through Technology (iHEART)

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ClinicalTrials.gov Identifier: NCT02731326
Recruitment Status : Active, not recruiting
First Posted : April 7, 2016
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Columbia University

Brief Summary:
Atrial fibrillation (AF), a condition where the top chambers of the heart beat irregularly, is a major health problem. The long-term goal of this project is to use a personal, mobile heart monitor to help patients better recognize recurrent AF and improve patients' ability to better manage their condition. A total of 300 patients with a history of AF will be included in the study, with 150 patients receiving an iPhone with the mobile monitoring device and educational text messaging and the remaining 150 patients continuing with their regular medical care. Each patient will be included in the intervention period for 6 months. The rate of recurrent AF and treatments meant to manage AF and other heart conditions will be determined for both groups. Patients in both groups will complete a series of questionnaires at the start and end of the 6 month study period to look at differences in quality of life and knowledge of AF.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Atrial Flutter Device: AliveCor Behavioral: Behavioral Altering Messaging Not Applicable

Detailed Description:
This study is a prospective randomized control trial with 1:1 randomization of 300 patients to either use the AliveCor device and receive behavioral altering motivational text messaging OR continue with usual care. The sample size and power was based on the test of the difference in AF detection rates between the intervention group and the control group in a similarly design pilot study. In the preliminary data there were 4 episodes of AF during the follow-up of 12 patients or a detection rate of 0.33 vs. a detection rate of 8% among controls. The detection window in this study as the time period from randomization to the 6-month follow-up will be defined. All patients' clinical records will be reviewed every month (via charts and/or internal and external electronic medical record systems) up until month 6 for initiations/changes in treatments targeting AF. A recurrence of AF in the chart and any related therapies that are initiated as a result of electrocardiogram (ECG) findings through usual cardiac care or from the AliveCor™ Heart Monitor will be specifically looked at. Changes in cardiovascular measures (blood pressure, glucose control, etc.) will be compared between groups. The effect of participating in the intervention, which includes targeted text messaging on AF knowledge and cardiovascular behavior change will be determined by comparing the change in AF knowledge scales from baseline to 6 months. This study will also measure and compare the incidence of documented AF in both groups, changes in prescribed treatment by healthcare providers over the 6-month period, and the relationship of the intervention to changes in cardiac measures and quality-adjusted life-years (QALYs) measured at baseline and 6 months. A biannual time period was chosen to capture AF redetection, changes in AF treatment, and self-reported quality of life based on other studies that have shown biannual time-points as most appropriate for collecting the proposed study endpoints.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: iPhone Helping Evaluate Atrial Fibrillation Rhythm Through Technology
Study Start Date : March 2015
Actual Primary Completion Date : July 2019
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: iHEART
Participants will transmit daily ECGs using AliveCor for 6 months following cardioversion or ablation procedure to treat AF/AFL. Participants will also receive read-only behavioral altering messaging three times per week focusing on AF, cardiovascular risk factors, and healthy living.
Device: AliveCor
The AliveCor Heart Monitor, an FDA-approved smartphone technology, snaps on to the patient's study smartphone similar to a protective case and works through a free application, "AliveECG". It captures a highly sensitive (98%), specific (97%), and accurate (97%) single-lead ECG recording through two electrodes on the back of the patient's smartphone. When the application is opened, recording begins automatically when both electrodes make contact with skin. Transmissions are automatically uploaded to the study patient portal within the AliveCor "cloud".

Behavioral: Behavioral Altering Messaging
Behavioral altering messages relating to the participant's AF and underlying cardiac risk factors will be systematically selected from a bank of text messages developed through collaboration by the study team and an expert interdisciplinary panel from the American Heart Association. The content of the text messages will not include PHI. The final text message bank will be housed internally and maintained by the Data Manager and text messages will be pushed automatically from this database. The only identifying link to participants included in this database will be their study-provided phone number

No Intervention: Usual Care
Participants will continue with usual care with their physician.



Primary Outcome Measures :
  1. Rate of recurrence of atrial arrhythmias [ Time Frame: Six months ]
    Examine the rate of recurrent atrial arrhythmias between the intervention and control group during the study period. The investigators will define and calculate recurrent AF detection rate as the ratio of the number of recurrent AF episodes to the number of person-months of follow-ups.

  2. Difference in treatment outcomes initiated by recurrence [ Time Frame: Six months ]
    Examine the type of treatment and time-to-treatment for recurrent atrial arrhythmias between the intervention and control group. For those who are treated for recurrent AF, the time-to-treatment is the time from beginning of study to the time of treatment.


Secondary Outcome Measures :
  1. Difference in Mean Quality-Adjusted Life-Years between Groups [ Time Frame: Six Months ]
    Calculate the mean quality-adjusted life-years (QALYs) in those in the iHEART intervention as compared to the control group during the six month study period. Quality-adjusted life-years (QALYs) is calculated as follows: for each month of life lived at an EQ-5D index of x, the QALYs will be x/12=0.0833x years. The investigators will calculate QALYs during the 6-month study period for all patients by summarizing QALYs from baseline through six months.

  2. Change in Atrial Fibrillation Knowledge Scale (AFKS) Scores between Baseline and Six Months Chronic Cardiovascular Conditions [ Time Frame: Six months ]
    Correlation between educational text messaging and participation in intervention on AF knowledge will be determined by comparing the change in mean scores between groups from the Atrial Fibrillation Knowledge Scale (AFKS) from baseline to 6 months. The AFKS is an 11-item scale including questions about AF in general, symptom recognition, and treatment and is validated (Cronbach α 0.58) to differentiate between knowledge changes in patients with AF.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females (English or Spanish speaking) age ≥ 18 years with a history of AF in the last 30 days that was treated with normal rhythm restored.
  • Ability to successfully use the AliveCor™ Heart Monitor, capture a baseline ECG, and transmit on the day of enrollment
  • Demonstrated ability to receive, read, and send a text messages on the day of enrollment
  • Willingness to complete the study questionnaires at baseline and 6 months

Exclusion Criteria:

  • Documented permanent (chronic) AF
  • Patient found to be in AF or other rhythm disturbances on the day of enrollment (i.e., they need to be clinically evaluated or treated)
  • Unwillingness have their clinical data collected over the study period
  • Unwillingness to receive and read cardiovascular text messaging three times a week.

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): NCT02731326


Locations
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United States, New York
Columbia University Medical Center
New York, New York, United States, 10025
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Suzanne Bakken, PhD, RN Columbia University
Publications of Results:
Other Publications:
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Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT02731326    
Other Study ID Numbers: AAAO2555
First Posted: April 7, 2016    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Research data will be disseminated for the whole study sample and not individually.
Additional relevant MeSH terms:
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Atrial Fibrillation
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes