Trial Outcomes & Findings for Feasibility Study to Improve AF Outcomes Using a Digital Application for CV Risk Reduction (NCT NCT04050982)
NCT ID: NCT04050982
Last Updated: 2023-09-22
Results Overview
TERMINATED
NA
11 participants
Baseline through month 6
2023-09-22
Participant Flow
Participant milestones
| Measure |
Pilot Testing
Patients interface with the AF CARE digital platform, providing feedback on usability and satisfaction.
|
AF CARE Plus Usual Care
Patients interface with the AF CARE digital platform and receive usual care.
|
Usual Care Then AF Care
After a 6 month period of usual care only, patients will interface with the AF CARE digital platform.
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
2
|
0
|
|
Overall Study
Interfaced With AF CARE Digital Platform
|
7
|
1
|
0
|
|
Overall Study
COMPLETED
|
7
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
0
|
Reasons for withdrawal
| Measure |
Pilot Testing
Patients interface with the AF CARE digital platform, providing feedback on usability and satisfaction.
|
AF CARE Plus Usual Care
Patients interface with the AF CARE digital platform and receive usual care.
|
Usual Care Then AF Care
After a 6 month period of usual care only, patients will interface with the AF CARE digital platform.
|
|---|---|---|---|
|
Overall Study
Did not meet eligibility criteria
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Unable to enroll on platform
|
1
|
0
|
0
|
Baseline Characteristics
Feasibility Study to Improve AF Outcomes Using a Digital Application for CV Risk Reduction
Baseline characteristics by cohort
| Measure |
Pilot Testing
n=9 Participants
Patients interface with the AF CARE digital platform, providing feedback on usability and satisfaction.
|
AF CARE Plus Usual Care
n=2 Participants
Patients interface with the AF CARE digital platform and receive usual care.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline through month 6Population: Data for this outcome measure were collected only in the Pilot Testing group. Only participants who interfaced with the AF CARE platform are included.
Outcome measures
| Measure |
Pilot Testing
n=7 Participants
Patients interface with the AF CARE digital platform, providing feedback on usability and satisfaction.
|
|---|---|
|
Percentage of Text Messages That Were Reviewed
|
29.2 percentage of texts
Interval 0.0 to 60.0
|
PRIMARY outcome
Timeframe: Baseline through month 6Population: Data for this outcome measure were collected only in the Pilot Testing group. Only participants who interfaced with the AF CARE platform are included.
Percentage of emails opened, and of those opened, the percentage of emails clicked through
Outcome measures
| Measure |
Pilot Testing
n=7 Participants
Patients interface with the AF CARE digital platform, providing feedback on usability and satisfaction.
|
|---|---|
|
Percentage of Emails Opened and Clicked Through
Emails opened
|
72.2 percentage of emails
Interval 19.0 to 97.0
|
|
Percentage of Emails Opened and Clicked Through
Emails clicked through
|
74.3 percentage of emails
Interval 36.0 to 100.0
|
PRIMARY outcome
Timeframe: Baseline, month 3, month 6, and month 12Population: Data for this outcome measure were collected only in the AF CARE plus Usual Care group. Only participants who interfaced with the AF CARE platform are included.
The American Heart Association Life Simple 7 (LS7) is a calculated score using lab values, biometric measurements, and patient dietary responses. Score range: 0 to 10; 0 = most risk, 10 = least risk
Outcome measures
| Measure |
Pilot Testing
n=1 Participants
Patients interface with the AF CARE digital platform, providing feedback on usability and satisfaction.
|
|---|---|
|
Cardiovascular Risk Factor Score
baseline
|
6.5 score on a scale
Standard Deviation 0
|
|
Cardiovascular Risk Factor Score
month 3
|
8 score on a scale
Standard Deviation 0
|
|
Cardiovascular Risk Factor Score
month 6
|
6.5 score on a scale
Standard Deviation 0
|
|
Cardiovascular Risk Factor Score
month 12
|
7 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Baseline, month 3, month 6, and month 12Population: Data for this outcome measure were collected only in the AF CARE plus Usual Care group. Only participants who interfaced with the AF CARE platform are included.
AF knowledge assessed with the Jessa AF Knowledge Score calculated from a 16 question self- reported questionnaire with a scoring range from 0-16, 16 indicating greater knowledge.
Outcome measures
| Measure |
Pilot Testing
n=1 Participants
Patients interface with the AF CARE digital platform, providing feedback on usability and satisfaction.
|
|---|---|
|
Change From Baseline in Knowledge Related to Atrial Fibrillation
baseline
|
12 score on a scale
Standard Deviation 0
|
|
Change From Baseline in Knowledge Related to Atrial Fibrillation
month 3
|
11 score on a scale
Standard Deviation 0
|
|
Change From Baseline in Knowledge Related to Atrial Fibrillation
month 6
|
15 score on a scale
Standard Deviation 0
|
|
Change From Baseline in Knowledge Related to Atrial Fibrillation
month 12
|
15 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Baseline, month 3, month 6, and month 12Population: Data for this outcome measure were collected only in the AF CARE plus Usual Care group. Only participants who interfaced with the AF CARE platform are included.
Quality of Life assessed using a patient completed questionnaire, Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT). The AFEQT score is a combined score of 21 items; overall score range is 21 to 100, with a higher score representing greater QOL.
Outcome measures
| Measure |
Pilot Testing
n=1 Participants
Patients interface with the AF CARE digital platform, providing feedback on usability and satisfaction.
|
|---|---|
|
Change From Baseline in AF Quality of Life Score
baseline
|
82 score on a scale
Standard Deviation 0
|
|
Change From Baseline in AF Quality of Life Score
month 3
|
65 score on a scale
Standard Deviation 0
|
|
Change From Baseline in AF Quality of Life Score
month 6
|
67 score on a scale
Standard Deviation 0
|
|
Change From Baseline in AF Quality of Life Score
month 12
|
51 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Baseline, month 3, month 6, and month 12Population: Data for this outcome measure were collected only in the AF CARE plus Usual Care group. Only participants who interfaced with the AF CARE platform are included.
AF symptom severity assessed with the Atrial Fibrillation Symptoms Severity Scale (AFSS). The AFSS is a patient self-reported questionnaire that contains 21 questions, with 7 questions that provide calculated scores for AF symptom severity (0-35) with higher scores representing greater severity.
Outcome measures
| Measure |
Pilot Testing
n=1 Participants
Patients interface with the AF CARE digital platform, providing feedback on usability and satisfaction.
|
|---|---|
|
Change From Baseline in AF Symptom Severity
baseline
|
0 score on a scale
Standard Deviation 0
|
|
Change From Baseline in AF Symptom Severity
month 3
|
15 score on a scale
Standard Deviation 0
|
|
Change From Baseline in AF Symptom Severity
month 6
|
21 score on a scale
Standard Deviation 0
|
|
Change From Baseline in AF Symptom Severity
month 12
|
23 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Baseline, month 3, month 6, and month 12Population: Data for this outcome measure were collected only in the AF CARE plus Usual Care group. Only participants who interfaced with the AF CARE platform are included.
AF symptom burden assessed with the Atrial Fibrillation Symptom Severity Scale. The AFSS is a patient self-reported questionnaire that contains 21 questions that provides calculated scores for AF Burden, calculated in the following manner; AF Burden = AF frequency + AF duration + AF severity. Each of the 3 measures contribute equally to the AF burden score, and each measure ranges from 1-10 to yield Total AF Burden scores ranging from 3-30. Higher scores indicate greater AF burden.
Outcome measures
| Measure |
Pilot Testing
n=1 Participants
Patients interface with the AF CARE digital platform, providing feedback on usability and satisfaction.
|
|---|---|
|
Change From Baseline in AF Symptom Burden
baseline
|
2 score on a scale
Standard Deviation 0
|
|
Change From Baseline in AF Symptom Burden
month 3
|
16 score on a scale
Standard Deviation 0
|
|
Change From Baseline in AF Symptom Burden
month 6
|
19 score on a scale
Standard Deviation 0
|
|
Change From Baseline in AF Symptom Burden
month 12
|
22 score on a scale
Standard Deviation 0
|
Adverse Events
Pilot Testing
AF CARE Plus Usual Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place