Individualized Studies of Triggers of Paroxysmal Atrial Fibrillation (I-STOP-AFib)
Primary Purpose
Atrial Fibrillation Paroxysmal
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
N-of-1
Data Tracking
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation Paroxysmal
Eligibility Criteria
Inclusion Criteria:
- symptomatic paroxysmal AF
- a smartphone
Exclusion Criteria:
- Non-English speakers
- Children (age < 18 years)
- Patients with plans to substantially change AF management (such as with ablation or change in antiarrhythmic drugs) over the ensuing 6 months
- Unwillingness to test AF triggers.
- Patients who have had an AV node or AV Junction ablation
Sites / Locations
- University of California, San Francisco
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
N-of-1
Data Tracking
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Atrial fibrillation quality of life
Atrial fibrillation quality of life will be measured by the Atrial Fibrillation Effect on QualiTy of Life survey (AFEQT). The primary outcome will be change in AFEQT score from baseline to 10 weeks and will compare the N-of-1 arm to the data tracking arm.
Secondary Outcome Measures
Full Information
NCT ID
NCT03323099
First Posted
October 24, 2017
Last Updated
February 5, 2021
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT03323099
Brief Title
Individualized Studies of Triggers of Paroxysmal Atrial Fibrillation
Acronym
I-STOP-AFib
Official Title
Using N-of-1 Experiments to Answer Patient Generated Research Questions
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 20, 2019 (Actual)
Primary Completion Date
April 3, 2020 (Actual)
Study Completion Date
April 3, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
N-of-1 Trial arm: Participants will use the Eureka mobile application and AliveCor device to execute at least one N-of-1 trial with the goal of identifying and better controlling their AF triggers. Each N-of-1 trial will last a total of 6 weeks and will include up to 3 periods of trigger exposure and 3 periods of trigger elimination with each exposure/elimination period lasting 1 week. Participants will be randomly assigned to start their trial with a period of either trigger exposure or elimination. During each N-of-1 trial, participants will track daily AF duration and severity, daily mood and sleep quality, daily AliveCor tracings and daily trigger exposure. At the end of each trial, participants will be able to review their trial results which will include visualizations of their daily AF symptom and trigger tracking over time. After completing a trial, participants will be instructed to implement any lifestyle changes they deem appropriate based on what they learned from the results of their trial. Participants will implement these changes for a period of 4 weeks during which they will continue to track AF episode duration and severity via the app. At the end of the 4-week lifestyle change period, participants will complete the Atrial Fibrillation Effect on QualiTy of Life survey (AFEQT) and will then have the option of testing another trigger or ending their study participation.
Symptom Surveillance arm: Participants will use the Eureka app and AliveCor device to record daily AF duration and severity, daily AliveCor readings and daily mood and sleep quality for a period of 10 weeks. Participants will be able to visualize their AF, sleep and mood data in real time and will receive a weekly summary of their data via the Eureka app.At the end of the 10-week data tracking period, participants will complete the AFEQT survey and will then have the option of either ending their study participation or crossing over to the N-of-1 trial arm to test their triggers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation Paroxysmal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
N-of-1
Arm Type
Experimental
Arm Description
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.
Arm Title
Data Tracking
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
N-of-1
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Data Tracking
Intervention Description
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.
Primary Outcome Measure Information:
Title
Atrial fibrillation quality of life
Description
Atrial fibrillation quality of life will be measured by the Atrial Fibrillation Effect on QualiTy of Life survey (AFEQT). The primary outcome will be change in AFEQT score from baseline to 10 weeks and will compare the N-of-1 arm to the data tracking arm.
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
symptomatic paroxysmal AF
a smartphone
Exclusion Criteria:
Non-English speakers
Children (age < 18 years)
Patients with plans to substantially change AF management (such as with ablation or change in antiarrhythmic drugs) over the ensuing 6 months
Unwillingness to test AF triggers.
Patients who have had an AV node or AV Junction ablation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory M Marcus, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34775507
Citation
Marcus GM, Modrow MF, Schmid CH, Sigona K, Nah G, Yang J, Chu TC, Joyce S, Gettabecha S, Ogomori K, Yang V, Butcher X, Hills MT, McCall D, Sciarappa K, Sim I, Pletcher MJ, Olgin JE. Individualized Studies of Triggers of Paroxysmal Atrial Fibrillation: The I-STOP-AFib Randomized Clinical Trial. JAMA Cardiol. 2022 Feb 1;7(2):167-174. doi: 10.1001/jamacardio.2021.5010.
Results Reference
derived
Learn more about this trial
Individualized Studies of Triggers of Paroxysmal Atrial Fibrillation
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