Shared Decision-Making: AFib 2gether Mobile App

Atrial Fibrillation New Onset Clinical Trial

— AFib 2gether  

Official title:

Shared Decision-Making: Implementing the AFib 2getherTM Mobile App

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04118270
• Other study ID #: H00018053
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: June 26, 2020

Study information

• Verified date: March 2022
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Shared Decision-Making: AFib 2gether™ is a research study that focuses on a mobile application developed by Pfizer, Inc with consultation from Dr McManus' called AFib 2gether™. Through this app, patients can determine their risk of stroke due to atrial fibrillation and prioritize questions and concerns for discussion with their cardiology provider.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 26, 2020
• Est. primary completion date: June 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Providers:

• Caring for at least 3 patients aged 18 years and older

• Have at least 3 patients with International Classification of Diseases tenth revision (ICD-10) diagnostic code consistent with atrial fibrillation (AF) or atrial flutter

• Have at least 3 patients with a CHA2DS2-VASc stroke risk score of 2 or more

• Have at least 3 patients who are not on anticoagulation

• Have at least 3 patients with upcoming appointments within the next 4 months

Patients:

• Age 18+

• Preferred language is English

• Atrial fibrillation diagnosis

• Chads vasc score 2 or higher

• Not on anticoagulants

• No watchman or atrial appendage closure

• Had an ambulatory care center (ACC) cardiology appointment in the past 12 months

• Future appointment in the next 4 months with the same provider

Exclusion Criteria:

Providers:

• Providers who do not care for at least 3 patients aged 18 years and older

• Have patients that do not have an ICD-10 diagnostic code consistent with AF or atrial flutter

• Does not have patients with a CHA2DS2-VASc stroke risk score of 2 or more

• Their patients are on anticoagulation

• Their 3 patients do not have an upcoming visit within the next 4 months

Patients:

• Under the age of 18; patients

• No ICD-10 diagnostic code consistent with AF or atrial flutter

• Did not have a visit with a cardiovascular medicine specialist in the previous one year

• Patients with a CHA2DS2-VASc score less than 2

• Currently prescribed an anticoagulant

• No upcoming cardiology visit in the next 3 months

• Has a WATCHMAN device or left atrial appendage closure surgery

• On hospice or for whom life expectancy is less than six months and patients

• Bleeding episode or fall with injury in the last four weeks

• Does not speak English

• Prisoner

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation New Onset

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	UMass Medical School	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Patients Placed on Anticoagulation After Cardiology Appointment	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.	up to 6 months
Primary	Patient MARS Scores	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.	Immediately after visit
Secondary	Provider MARS Scores	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.	Immediately after visit.
Secondary	Reason Why the Patient Was Not on AC Prior to Their Appointment	This was an evaluation of why the patient was not on an anticoagulant (AC) prior to their appointment.	Immediately after visit
Secondary	Afib 2gether Accuracy Assessment	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.	Immediately after visit.