CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 499 enrolled
Drug / intervention
N-of-1 +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03323099
NCT03323099N/ACompleted
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Using N-of-1 Experiments to Answer Patient Generated Research Questions

University of California, San Francisco·interventional·Posted Oct 26, 2017·Updated Nov 8, 2023

In Brief

A clinical study evaluating N-of-1 and Data Tracking for Atrial Fibrillation Paroxysmal. Completed, enrolled 499 participants across 1 site.

Detailed Summary

The I-STOP-Afib study will test the comparative effectiveness of using N-of-1 trials vs. symptom surveillance alone to reduce Atrial Fibrillation (AF) episode frequency and severity and improve quality of life for AF patients. The study will involve randomizing almost 500 paroxysmal AF patients to either AF episode tracking versus engaging in testing the relationship between participant-selected triggers and AF episodes utilizing a mobile-app based N-of-1 study design. Both groups will complete a validated survey to assess AF severity, essentially a measure of quality of life while living with AF, before and after a 3 month testing period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation Paroxysmal
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedOct 26, 2017
Enrollment StartMar 20, 2019
Primary CompletionApr 3, 2020
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 8.7 years ago

Interventions

N-of-1behavioral

Participants in the N-of-1 arm will use the Eureka mobile application and AliveCor device to tracking their AF episode frequency and severity and execute at least one N-of-1 trial with the goal of identifying and better controlling their AF triggers.

Data Trackingbehavioral

Participants in the data tracking arm will use the Eureka app and AliveCor device to record daily AF frequency and severity and daily AliveCor readings for a period of 10 weeks.