Trial Outcomes & Findings for Shared Decision-Making: AFib 2gether Mobile App (NCT NCT04118270)
NCT ID: NCT04118270
Last Updated: 2022-05-02
Results Overview
Patients evaluated the perceived usefulness of the AFib 2gether mobile application by taking the Mobile App Rating Scale (MARS) questionnaire. This evaluated 3 domains: functionality, aesthetics, and a star-based question. These scores are rated 1-5 with 5 being the highest (best) score.
COMPLETED
NA
50 participants
Immediately after visit
2022-05-02
Participant Flow
We identified 40 patients seeing 13 cardiology providers. Of the 40 patients, 2 were later found ineligible and 1 patient was disenrolled due to provider preference leaving us with 37 patient encounters to analyze. Of the 13 providers, 10 completed the accuracy assessment.
Participant milestones
| Measure |
AFib 2gether(TM) App
Patients with known Atrial Fibrillation will be assigned to download and use an app targeted at determining stroke risk and increasing knowledge of Atrial Fibrillation and stroke risk along with treatment options and will use this information to facilitate a discussion with their cardiovascular provider.
Afib 2gether TM Mobile Application: The Afib 2gether mobile app determines a patient's stroke risk through a series of questions that the patient will answer in the app.
|
Providers
Providers caring for the patients with known Atrial Fibrillation will be asked to review the patients' stroke risk score on the AFib 2gether app and compare to their clinical assessment for accuracy.
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
13
|
|
Overall Study
Completed Provider Accuracy Assessment
|
0
|
10
|
|
Overall Study
COMPLETED
|
37
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Shared Decision-Making: AFib 2gether Mobile App
Baseline characteristics by cohort
| Measure |
AFib 2gether(TM) App
n=37 Participants
Patients with known Atrial Fibrillation will be assigned to download and use an app targeted at determining stroke risk and increasing knowledge of Atrial Fibrillation and stroke risk along with treatment options and will use this information to facilitate a discussion with their cardiovascular provider.
Afib 2gether TM Mobile Application: The Afib 2gether mobile app determines a patient's stroke risk through a series of questions that the patient will answer in the app.
|
Providers
Providers caring for the patients with known Atrial Fibrillation will be asked to review the patients' stroke risk score on the AFib 2gether app and compare to their clinical assessment for accuracy. Baseline measures were not collected for providers.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age: 75+
|
17 Participants
n=93 Participants
|
—
|
17 Participants
n=27 Participants
|
|
Age, Customized
Age: 65-74
|
14 Participants
n=93 Participants
|
—
|
14 Participants
n=27 Participants
|
|
Age, Customized
Age: <65
|
6 Participants
n=93 Participants
|
—
|
6 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
—
|
11 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=93 Participants
|
—
|
26 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=93 Participants
|
—
|
36 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
—
|
1 Participants
n=27 Participants
|
|
Stroke Risk Score
CHA2DS2-VASc score: 2
|
9 Participants
n=93 Participants
|
—
|
9 Participants
n=27 Participants
|
|
Stroke Risk Score
CHA2DS2-VASc score: 3
|
10 Participants
n=93 Participants
|
—
|
10 Participants
n=27 Participants
|
|
Stroke Risk Score
CHA2DS2-VASc score: 4
|
9 Participants
n=93 Participants
|
—
|
9 Participants
n=27 Participants
|
|
Stroke Risk Score
CHA2DS2-VASc score: 5
|
6 Participants
n=93 Participants
|
—
|
6 Participants
n=27 Participants
|
|
Stroke Risk Score
CHA2DS2-VASc score: 6
|
2 Participants
n=93 Participants
|
—
|
2 Participants
n=27 Participants
|
|
Stroke Risk Score
CHA2DS2-VASc score: 7
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Stroke Risk Score
CHA2DS2-VASc score: 8
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Stroke Risk Score
CHA2DS2-VASc score: 9
|
1 Participants
n=93 Participants
|
—
|
1 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Immediately after visitPopulation: Patients with a stroke risk score of 2 or higher and have a diagnosis of AF.
Patients evaluated the perceived usefulness of the AFib 2gether mobile application by taking the Mobile App Rating Scale (MARS) questionnaire. This evaluated 3 domains: functionality, aesthetics, and a star-based question. These scores are rated 1-5 with 5 being the highest (best) score.
Outcome measures
| Measure |
Patient
n=37 Participants
Patients with a stroke risk score of 2 or higher and have a active diagnosis of atrial fibrillation (AF).
|
|---|---|
|
Patient MARS Scores
Functionality
|
4.51 score on a scale
Standard Deviation 0.61
|
|
Patient MARS Scores
Aesthetics
|
4.26 score on a scale
Standard Deviation 0.51
|
|
Patient MARS Scores
Star-Based
|
4.24 score on a scale
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: Immediately after visit.Population: Providers are considered to be enrolled in the study.
Providers were asked to navigate the app features and rate their overall opinion of the mobile app by answering questions using the Mobile App Rating Scale (MARS). This scale evaluates 3 domains: functionality, aesthetics, and a star-based rating question. These scores are rated 1-5 with 5 being the highest (best) score.
Outcome measures
| Measure |
Patient
n=13 Participants
Patients with a stroke risk score of 2 or higher and have a active diagnosis of atrial fibrillation (AF).
|
|---|---|
|
Provider MARS Scores
Functionality
|
4.19 units on a scale
Standard Deviation 0.50
|
|
Provider MARS Scores
Aesthetics
|
4.04 units on a scale
Standard Deviation 0.50
|
|
Provider MARS Scores
Star-Based
|
3.76 units on a scale
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: Immediately after visitThis was an evaluation of why the patient was not on an anticoagulant (AC) prior to their appointment.
Outcome measures
| Measure |
Patient
n=37 Participants
Patients with a stroke risk score of 2 or higher and have a active diagnosis of atrial fibrillation (AF).
|
|---|---|
|
Reason Why the Patient Was Not on AC Prior to Their Appointment
Low AF Burden
|
16 participants
|
|
Reason Why the Patient Was Not on AC Prior to Their Appointment
Refused
|
10 participants
|
|
Reason Why the Patient Was Not on AC Prior to Their Appointment
Not Listed
|
5 participants
|
|
Reason Why the Patient Was Not on AC Prior to Their Appointment
Fall Risk
|
1 participants
|
|
Reason Why the Patient Was Not on AC Prior to Their Appointment
GI Bleed
|
2 participants
|
|
Reason Why the Patient Was Not on AC Prior to Their Appointment
Other Bleed
|
3 participants
|
SECONDARY outcome
Timeframe: Immediately after visit.Population: Providers are considered enrolled in the study.
The provider was asked to review the patients stroke risk score on the AFib 2gether app and compare to provider clinical assessment for accuracy. The number of accurate scores were recorded. Ten of the original thirteen providers completed this assessment.
Outcome measures
| Measure |
Patient
n=10 Participants
Patients with a stroke risk score of 2 or higher and have a active diagnosis of atrial fibrillation (AF).
|
|---|---|
|
Afib 2gether Accuracy Assessment
|
10 accurate scores
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 6 monthsPopulation: Patients with AF with a stroke risk score that is 2 or higher.
This outcome measures the number of patient participants with a CHA2DS2-VASc stroke scale score of 2 or higher who are placed on anticoagulation therapy following cardiology appointment. Patients switch to AC will be monitored via the electronic health record. The CHA2DS2-VASc scale is an evaluation of stroke risk for patients with atrial fibrillation. The scale is a composite of 7 questions, with an overall scale score of 0 to 9, with low scores indicating low risk for stroke, and high scores indicating high risk for stroke.
Outcome measures
| Measure |
Patient
n=37 Participants
Patients with a stroke risk score of 2 or higher and have a active diagnosis of atrial fibrillation (AF).
|
|---|---|
|
Number of Patients Placed on Anticoagulation After Cardiology Appointment
|
12 Participants
|
Adverse Events
AFib 2gether(TM) App
Providers
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