Atrial Fibrillation ParoxysmalI-STOP-AFibNCT03323099
Individualized Studies of Triggers of Paroxysmal Atrial Fibrillation
A study testing N-of-1 and Data Tracking in people with Atrial Fibrillation Paroxysmal, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation Paroxysmal
- What is being tested?
- N-of-1 and Data Tracking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 499 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2019to 3 Apr 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- symptomatic paroxysmal AF
- a smartphone
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: 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.
Read the 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.
- Conditions
- Atrial Fibrillation Paroxysmal
- Being tested
- N-of-1, Data Tracking
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-of-1Behavioural
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 TrackingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: N-of-1 |
| 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. Receives: Behavioral: Data Tracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start20 Mar 2019
- Primary completion3 Apr 2020
- Study completion3 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation ParoxysmalStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 499 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory M Marcus, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323099
- Sponsor's protocol ID
- A129075
- Acronym
- I-STOP-AFib
- Status last verified
- Jan 2023
- First submitted
- 24 Oct 2017
- Last updated
- 8 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34775507
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using N-of-1 Experiments to Answer Patient Generated Research Questions
- ClinicalTrials.gov ID
- NCT03323099
- Acronym / sponsor ID
- I-STOP-AFib / A129075
- Conditions
- Atrial Fibrillation Paroxysmal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 499 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 3 Apr 2020 (actual)
- Study completion
- 3 Apr 2020 (actual)
- First posted
- 26 Oct 2017 (actual)
- Results
- Posted 8 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-of-1 | Experimental | Behavioral: N-of-1Participants 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 | Behavioral: Data TrackingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- symptomatic paroxysmal AF
- a smartphone
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-of-1Participants 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. | Behavioural | N-of-1 |
| Data TrackingParticipants 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. | Behavioural | Data Tracking |
Primary outcome
Change in Atrial Fibrillation Effect on QualiTy of Life Survey (AFEQT)
Time frame: 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34775507Marcus 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory M Marcus, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N-of-1 and Data Tracking in people with Atrial Fibrillation Paroxysmal, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Atrial Fibrillation Effect on QualiTy of Life Survey (AFEQT) (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03323099, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.