Atrial Fibrillation Paroxysmal
Conditions
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.
Interventions
BEHAVIORALN-of-1
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.
BEHAVIORALData Tracking
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.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Atrial Fibrillation Effect on QualiTy of Life Survey (AFEQT) | 10 weeks | Change in 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 measurement to measurement at 10 weeks. Change in the AFEQT will compared between the N-of-1 arm and the data tracking arm. The Atrial Fibrillation Effect on QualiTy-of-life Questionnaire (AFEQT) evaluates symptoms, daily activities and treatment concerns patients have related to atrial fibrillation (AF or AFib). Patients score 0 (worst) to 100 (best). |
Countries
United States
Participant flow
Recruitment details
2,987 individuals screened between December 22, 2018 and March 29, 2020, 740 met eligibility criteria, 684 consented, 499 began randomization activities, and 446 completed activities required for implementation of randomization. 320 Participants completed all study activities. The first participant was enrolled March 20th, 2019.
Participants by arm
| Arm | Count |
|---|---|
| N-of-1 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.
N-of-1: 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. | 251 |
| Data Tracking 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.
Data Tracking: 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. | 248 |
| Total | 499 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not complete AFEQT, or failed to start the study period | 109 | 52 |
| Overall Study | Withdrawal by Subject | 6 | 12 |
Baseline characteristics
| Characteristic | N-of-1 | Data Tracking | Total |
|---|---|---|---|
| Age, Continuous | 57.52 years STANDARD_DEVIATION 14 | 58.2 years STANDARD_DEVIATION 14.04 | 57.85 years STANDARD_DEVIATION 14 |
| Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) score | 74 units on a scale STANDARD_DEVIATION 19 | 72 units on a scale STANDARD_DEVIATION 19 | 73 units on a scale STANDARD_DEVIATION 19 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 8 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 233 Participants | 233 Participants | 466 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 7 Participants | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 11 Participants | 9 Participants | 20 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 5 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) White | 233 Participants | 228 Participants | 461 Participants |
| Sex: Female, Male Female | 102 Participants | 108 Participants | 210 Participants |
| Sex: Female, Male Male | 149 Participants | 140 Participants | 289 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 251 | 0 / 248 |
| other Total, other adverse events | 0 / 251 | 0 / 248 |
| serious Total, serious adverse events | 8 / 251 | 16 / 248 |
Outcome results
Primary
Change in Atrial Fibrillation Effect on QualiTy of Life Survey (AFEQT)
Change in 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 measurement to measurement at 10 weeks. Change in the AFEQT will compared between the N-of-1 arm and the data tracking arm. The Atrial Fibrillation Effect on QualiTy-of-life Questionnaire (AFEQT) evaluates symptoms, daily activities and treatment concerns patients have related to atrial fibrillation (AF or AFib). Patients score 0 (worst) to 100 (best).
Time frame: 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| N-of-1 | Change in Atrial Fibrillation Effect on QualiTy of Life Survey (AFEQT) | 1.7 units on a scale | Standard Deviation 13 |
| Data Tracking | Change in Atrial Fibrillation Effect on QualiTy of Life Survey (AFEQT) | 0.5 units on a scale | Standard Deviation 14.1 |