iPhone Helping Evaluate Atrial Fibrillation Rhythm Through Technology

Not Applicable

Completed

• Conditions: Atrial Fibrillation; Atrial Flutter
• Interventions: Device: AliveCor; Behavioral: Behavioral Altering Messaging

• Registration Number: NCT02731326
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-03
• Study First Submitted: 2016-03-24
• Study First Submitted QC: 2016-04-06
• Study First Posted: 2016-04-07
• Primary Completion: 2019-08-31
• Results First Submitted: 2020-08-20
• Study Completion: 2020-12-31
• Status Verified: 2024-06
• Results First Submitted QC: 2024-06-08
• Last Update Submitted: 2024-06-08
• Results First Posted: 2024-07-03
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 264

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iHEART	Behavioral Altering Messaging	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.
iHEART	AliveCor	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.

Primary Outcome Measures

Name	Time	Method
Rate of Recurrence of Atrial Arrhythmias	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.
Number of Intervention and Control Group Patients Treated for Recurrent Atrial Arrhythmia	6 months	Number of intervention and control group patients with recurrent atrial arrhythmia who received treatment for recurrent atrial arrhythmia
Time to Treatment for Recurrence of Atrial Arrhythmia	Six months	Time to treatment for recurrence of atrial arrhythmia from detection of arrhythmia to 6 months

Secondary Outcome Measures

Name	Time	Method
Difference in Quality-Adjusted Life Years (QALYS) Between Intervention and Control Groups	Six Months	The EQ-5D index is a summary measure that assesses the value for preferring one health state to another. The full range of the EQ-5D index is 0 to 1. The EQ-5D index is anchored at 0 for death and 1 for full (optimal) health, so that having a reduced score of 0.5 is equivalent to living in full health only 50% of the time. Therefore, one year lived at a reduced EQ-5D index of 0.5 equals 0.5 QALYs which is the same as living a half year in full health. Higher scores mean a better outcome. QALYs were calculated from baseline to six months for patients whose EQ-5D index scores were available at both baseline and follow-up.
Change in Atrial Fibrillation Knowledge Scale (AFKS) Scores Between Baseline and Six Months	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 a valid instrument used to distinguish knowledge levels in AF patients. It 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. For each item patients can choose an answer out of three options, with one being the correct answer. The correct answer yields one point, while no points are added or subtracted to the score in case of an incorrect answer. The minimum score of the scale is 0 with a maximum score of 11.

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States