Shared Decision-Making: AFib 2gether Mobile App (AFib 2gether)

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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation New Onset
• Intervention / Treatment: Device: Afib 2gether TM Mobile Application

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • UMass Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: Pfizer
• Investigators: Principal Investigator: Alok Kapoor, MD, UMass Medical School

Publications and helpful links

General Publications

• Kapoor A, Hayes A, Patel J, Patel H, Andrade A, Mazor K, Possidente C, Nolen K, Hegeman-Dingle R, McManus D. Usability and Perceived Usefulness of the AFib 2gether Mobile App in a Clinical Setting: Single-Arm Intervention Study. JMIR Cardio. 2021 Nov 19;5(2):e27016. doi: 10.2196/27016.
• Kapoor A, Andrade A, Hayes A, Mazor K, Possidente C, Nolen K, Hegeman-Dingle R, McManus D. Usability, Perceived Usefulness, and Shared Decision-Making Features of the AFib 2gether Mobile App: Protocol for a Single-Arm Intervention Study. JMIR Res Protoc. 2021 Feb 24;10(2):e21986. doi: 10.2196/21986.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): June 26, 2020
• Study Completion (Actual): June 26, 2020

Study Registration Dates

• First Submitted: October 3, 2019
• First Submitted That Met QC Criteria: October 4, 2019
• First Posted (Actual): October 8, 2019

Study Record Updates

• Last Update Posted (Actual): May 2, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: H00018053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes