Trial Outcomes & Findings for Individualized Studies of Triggers of Paroxysmal Atrial Fibrillation (NCT NCT03323099)
NCT ID: NCT03323099
Last Updated: 2023-11-08
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
499 participants
Primary outcome timeframe
10 weeks
Results posted on
2023-11-08
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
251
|
248
|
|
Overall Study
COMPLETED
|
136
|
184
|
|
Overall Study
NOT COMPLETED
|
115
|
64
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
12
|
|
Overall Study
Did not complete AFEQT, or failed to start the study period
|
109
|
52
|
Baseline Characteristics
1 participant in the N-of-1 arm had a missing Baseline AFEQT score
Baseline characteristics by cohort
| Measure |
N-of-1
n=251 Participants
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.
|
Data Tracking
n=248 Participants
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.
|
Total
n=499 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.52 years
STANDARD_DEVIATION 14 • n=251 Participants
|
58.2 years
STANDARD_DEVIATION 14.04 • n=248 Participants
|
57.85 years
STANDARD_DEVIATION 14 • n=499 Participants
|
|
Sex: Female, Male
Female
|
102 Participants
n=251 Participants
|
108 Participants
n=248 Participants
|
210 Participants
n=499 Participants
|
|
Sex: Female, Male
Male
|
149 Participants
n=251 Participants
|
140 Participants
n=248 Participants
|
289 Participants
n=499 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=251 Participants
|
8 Participants
n=248 Participants
|
24 Participants
n=499 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
233 Participants
n=251 Participants
|
233 Participants
n=248 Participants
|
466 Participants
n=499 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=251 Participants
|
7 Participants
n=248 Participants
|
9 Participants
n=499 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=251 Participants
|
0 Participants
n=248 Participants
|
0 Participants
n=499 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=251 Participants
|
9 Participants
n=248 Participants
|
20 Participants
n=499 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=251 Participants
|
0 Participants
n=248 Participants
|
1 Participants
n=499 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=251 Participants
|
5 Participants
n=248 Participants
|
7 Participants
n=499 Participants
|
|
Race (NIH/OMB)
White
|
233 Participants
n=251 Participants
|
228 Participants
n=248 Participants
|
461 Participants
n=499 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=251 Participants
|
2 Participants
n=248 Participants
|
5 Participants
n=499 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=251 Participants
|
4 Participants
n=248 Participants
|
5 Participants
n=499 Participants
|
|
Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) score
|
74 units on a scale
STANDARD_DEVIATION 19 • n=250 Participants • 1 participant in the N-of-1 arm had a missing Baseline AFEQT score
|
72 units on a scale
STANDARD_DEVIATION 19 • n=248 Participants • 1 participant in the N-of-1 arm had a missing Baseline AFEQT score
|
73 units on a scale
STANDARD_DEVIATION 19 • n=498 Participants • 1 participant in the N-of-1 arm had a missing Baseline AFEQT score
|
PRIMARY outcome
Timeframe: 10 weeksChange 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).
Outcome measures
| Measure |
N-of-1
n=135 Participants
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
n=184 Participants
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.
|
|---|---|---|
|
Change in Atrial Fibrillation Effect on QualiTy of Life Survey (AFEQT)
|
1.7 units on a scale
Standard Deviation 13.0
|
0.5 units on a scale
Standard Deviation 14.1
|
Adverse Events
N-of-1
Serious events: 8 serious events
Other events: 0 other events
Deaths: 0 deaths
Data Tracking
Serious events: 16 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
N-of-1
n=251 participants at risk
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.
|
Data Tracking
n=248 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
self report ER visit with AF
|
2.4%
6/251 • 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
|
3.6%
9/248 • 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
|
|
Cardiac disorders
self report hospital visit with AF
|
0.80%
2/251 • 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
|
2.8%
7/248 • 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
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place