iPhone Helping Evaluate Atrial Fibrillation Rhythm Through Technology (iHEART)
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02731326|
Recruitment Status : Active, not recruiting
First Posted : April 7, 2016
Last Update Posted : January 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Atrial Flutter||Device: AliveCor Behavioral: Behavioral Altering Messaging||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||264 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
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.
- 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.
- 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.
- 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.
- 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.
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
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10025|
|Principal Investigator:||Suzanne Bakken, PhD, RN||Columbia University|