Atrial Fibrillation Paroxysmal Clinical Trial
— I-STOP-AFibOfficial title:
Using N-of-1 Experiments to Answer Patient Generated Research Questions
NCT number | NCT03323099 |
Other study ID # | A129075 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 20, 2019 |
Est. completion date | April 3, 2020 |
Verified date | January 2023 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 499 |
Est. completion date | April 3, 2020 |
Est. primary completion date | April 3, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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). |
10 weeks |
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