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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N-of-1 | Experimental | 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 Tracking | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-of-1 | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory M Marcus, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34775507 | Derived | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | units on a scale | 10 weeks |
|
Data Collected in Primary Data collection period-- over first 10 weeks.
Adverse event information was collected via self report every month-- or twice during the primary data collection period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| self report ER visit with AF | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Greg Marcus | University of California San Francisco | 4154763393 | greg.marcus@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 20, 2017 | Oct 22, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 12, 2017 | Nov 16, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000080907 | Single-Case Studies as Topic |
| ID | Term |
|---|---|
| D002986 | Clinical Trials as Topic |
| D000068456 | Clinical Studies as Topic |
| D016020 | Epidemiologic Study Characteristics |
| D004812 | Epidemiologic Methods |
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| Data Tracking | Behavioral | 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. |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) score | 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). The AFEQT is the first questionnaire developed and validated for AF patients. Patients score 0 (worst) to 100 (best) | 1 participant in the N-of-1 arm had a missing Baseline AFEQT score | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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. |
|
|
| 0 |
| 251 |
| 8 |
| 251 |
| 0 |
| 251 |
| EG001 | 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. | 0 | 248 | 16 | 248 | 0 | 248 |
| self report hospital visit with AF | Cardiac disorders | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|