Individualized Studies of Triggers of Paroxysmal Atrial Fibrillation
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Atrial Fibrillation |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/7/2019 |
| Start Date: | April 2019 |
| End Date: | September 2020 |
| Contact: | Madelaine Faulkner, MPH |
| Email: | Madelaine.Faulkner@ucsf.edu |
| Phone: | (415)-476-3393 |
Using N-of-1 Experiments to Answer Patient Generated Research Questions
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.
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.
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.
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.
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
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