iPhone Helping Evaluate Atrial Fibrillation Rhythm Through Technology

NCT02731326 | Completed Results DMC

• 1 other identifier: AAAO2555
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Atrial Flutter

Outcome Measures

Primary Outcomes (3)

• Rate of Recurrence of Atrial Arrhythmias

  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.

  Six months

• Time to Treatment for Recurrence of Atrial Arrhythmia

  Time to treatment for recurrence of atrial arrhythmia from detection of arrhythmia to 6 months

  Six months

• Number of Intervention and Control Group Patients Treated for Recurrent Atrial Arrhythmia

  Number of intervention and control group patients with recurrent atrial arrhythmia who received treatment for recurrent atrial arrhythmia

  6 months

Secondary Outcomes (2)

• Difference in Quality-Adjusted Life Years (QALYS) Between Intervention and Control Groups

  Six Months

• Change in Atrial Fibrillation Knowledge Scale (AFKS) Scores Between Baseline and Six Months

  Six months

Study Arms (2)

iHEART

EXPERIMENTAL

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; Behavioral: Behavioral Altering Messaging

Usual Care

NO INTERVENTION

Participants will continue with usual care with their physician.

Interventions

AliveCor DEVICE

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".

iHEART

Behavioral Altering Messaging BEHAVIORAL

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

iHEART

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10025, United States

Location

Related Publications (8)

• 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.

  PMID: 29135066 BACKGROUND

• 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.

  PMID: 27422639 BACKGROUND

• 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.

  PMID: 29438185 BACKGROUND

• Hickey KT, Wan E, Garan H, Biviano AB, Morrow JP, Sciacca RR, Reading M, Koleck TA, Caceres B, Zhang Y, Goldenthal I, Riga TC, Masterson Creber R. A Nurse-led Approach to Improving Cardiac Lifestyle Modification in an Atrial Fibrillation Population. J Innov Card Rhythm Manag. 2019 Sep 15;10(9):3826-3835. doi: 10.19102/icrm.2019.100902. eCollection 2019 Sep.

  PMID: 32494426 BACKGROUND

• 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.

  PMID: 30304745 RESULT

• 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.

  PMID: 31507001 RESULT

• Koleck TA, Mitha SA, Biviano A, Caceres BA, Corwin EJ, Goldenthal I, Creber RM, Turchioe MR, Hickey KT, Bakken S. Exploring Depressive Symptoms and Anxiety Among Patients With Atrial Fibrillation and/or Flutter at the Time of Cardioversion or Ablation. J Cardiovasc Nurs. 2021 Sep-Oct 01;36(5):470-481. doi: 10.1097/JCN.0000000000000723.

  PMID: 32675627 RESULT

• Caceres BA, Hickey KT, Bakken SB, Biviano AB, Garan H, Goldenthal IL, Koleck TA, Masterson-Creber R, Turchioe MR, Jia H. Mobile Electrocardiogram Monitoring and Health-Related Quality of Life in Patients With Atrial Fibrillation: Findings From the iPhone Helping Evaluate Atrial Fibrillation Rhythm Through Technology (iHEART) Study. J Cardiovasc Nurs. 2020 Jul/Aug;35(4):327-336. doi: 10.1097/JCN.0000000000000646.

  PMID: 32015256 RESULT

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

While there was primary outcome data for all participants with the exception of 5 in the control group, secondary outcome measures reflect less than half the participants in the intervention and control groups due to missing data. Thus, findings related to secondary outcome measures should be interpreted with caution.

Results Point of Contact

• Title: Suzanne Bakken, PhD, RN
• Organization: Columbia University

sbh22@columbia.edu

212-305-1278

Study Officials

• Suzanne Bakken, PhD, RN

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Alumni Professor of the School of Nursing

Study Record Dates

• First Submitted: March 24, 2016
• First Posted: April 7, 2016
• Study Start: March 1, 2015
• Primary Completion: August 31, 2019
• Study Completion: December 31, 2020
• Last Updated: July 3, 2024
• Results First Posted: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)