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Shared Decision-Making: AFib 2gether Mobile App

Not Applicable
Completed
Conditions
Atrial Fibrillation New Onset
Registration Number
NCT04118270
Lead Sponsor
University of Massachusetts, Worcester
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
50
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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Patient MARS ScoresImmediately 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 Outcome Measures
NameTimeMethod
Provider MARS ScoresImmediately 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 AppointmentImmediately after visit

This was an evaluation of why the patient was not on an anticoagulant (AC) prior to their appointment.

Afib 2gether Accuracy AssessmentImmediately 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.

Trial Locations

Locations (1)

UMass Medical School

🇺🇸

Worcester, Massachusetts, United States

UMass Medical School
🇺🇸Worcester, Massachusetts, United States

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