iPhone Helping Evaluate Atrial Fibrillation Rhythm Through Technology (iHEART)

• ClinicalTrials.gov Identifier: NCT02731326
• Recruitment Status: Unknown
• First Posted: April 7, 2016
• Last Update Posted: January 13, 2020
• Sponsor: Columbia University
• Information provided by (Responsible Party): Columbia University

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

United States, New York

Columbia University Medical Center

New York, New York, United States, 10025

Sponsors and Collaborators

Columbia University

Investigators

• Principal Investigator: Suzanne Bakken, PhD, RN; Columbia University

More Information

Publications of Results:

Goldenthal IL, Sciacca RR, Riga T, Bakken S, Baumeister M, Biviano AB, Dizon JM, Wang D, Wang KC, Whang W, Hickey KT, Garan H. Recurrent atrial fibrillation/flutter detection after ablation or cardioversion using the AliveCor KardiaMobile device: iHEART results. J Cardiovasc Electrophysiol. 2019 Nov;30(11):2220-2228. doi: 10.1111/jce.14160. Epub 2019 Sep 25.

Other Publications:

Reading M, Baik D, Beauchemin M, Hickey KT, Merrill JA. Factors Influencing Sustained Engagement with ECG Self-Monitoring: Perspectives from Patients and Health Care Providers. Appl Clin Inform. 2018 Oct;9(4):772-781. doi: 10.1055/s-0038-1672138. Epub 2018 Oct 10.

Hickey KT. Developing and Sustaining a Career as a Transdisciplinary Nurse Scientist. J Nurs Scholarsh. 2018 Jan;50(1):20-27. doi: 10.1111/jnu.12359. Epub 2017 Nov 14.

Hickey KT, Hauser NR, Valente LE, Riga TC, Frulla AP, Masterson Creber R, Whang W, Garan H, Jia H, Sciacca RR, Wang DY. A single-center randomized, controlled trial investigating the efficacy of a mHealth ECG technology intervention to improve the detection of atrial fibrillation: the iHEART study protocol. BMC Cardiovasc Disord. 2016 Jul 16;16:152. doi: 10.1186/s12872-016-0327-y.

Hickey KT, Riga TC, Mitha SA, Reading MJ. Detection and management of atrial fibrillation using remote monitoring. Nurse Pract. 2018 Mar 12;43(3):24-30. doi: 10.1097/01.NPR.0000530214.17031.45.

• Responsible Party: Columbia University
• ClinicalTrials.gov Identifier: NCT02731326
• Other Study ID Numbers: AAAO2555
• First Posted: April 7, 2016
• 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:

Atrial Fibrillation; Atrial Flutter; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes