N/A
N=262
iPhone Helping Evaluate Atrial Fibrillation Rhythm Through Technology
Atrial Fibrillation · Atrial Flutter
Bottom Line
View on ClinicalTrials.gov: NCT02731326 ↗Enrolled (actual)
262
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Rate of Recurrence of Atrial Arrhythmias — 0.132; 0.091 episodes per person-month of follow-up — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- AliveCor (Device); Behavioral Altering Messaging (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Recurrence of Atrial Arrhythmias |
0.132; 0.091 | 0.05 |
| PRIMARY Time to Treatment for Recurrence of Atrial Arrhythmia |
43; 33 | 0.05 |
| PRIMARY Number of Intervention and Control Group Patients Treated for Recurrent Atrial Arrhythmia |
21; 35 | <.0001 sig |
| SECONDARY Difference in Quality-Adjusted Life Years (QALYS) Between Intervention and Control Groups |
0.94; 0.91 | 0.24 |
| SECONDARY Change in Atrial Fibrillation Knowledge Scale (AFKS) Scores Between Baseline and Six Months |
0.27; .17 | 0.89 |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02731326). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.