Shared Decision-Making: AFib 2gether Mobile App

Overview

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.

Full Title of Study: “Shared Decision-Making: Implementing the AFib 2getherTM Mobile App”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Screening
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 26, 2020

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Patient MARS Scores
    • Time Frame: Immediately after visit
    • 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.

Secondary Measures

  • Provider MARS Scores
    • Time Frame: Immediately after visit.
    • 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.
  • Reason Why the Patient Was Not on AC Prior to Their Appointment
    • Time Frame: Immediately after visit
    • This was an evaluation of why the patient was not on an anticoagulant (AC) prior to their appointment.
  • Afib 2gether Accuracy Assessment
    • Time Frame: Immediately after visit.
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Massachusetts, Worcester
  • Collaborator
    • Pfizer
  • Provider of Information About this Clinical Study
    • Principal Investigator: Alok Kapoor, Associate Professor – University of Massachusetts, Worcester
  • Overall Official(s)
    • Alok Kapoor, MD, Principal Investigator, UMass Medical School

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