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Completed

NCT Number: NCT04118270

Shared Decision-Making: AFib 2gether 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.

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Key information

Conditions

Atrial Fibrillation New Onset

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMass Medical School

Worcester, Massachusetts, 01655, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Afib 2gether TM Mobile Application

Device

The Afib 2gether mobile app determines a patient's stroke risk through a series of questions that the patient will answer in the app.

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. Number of Patients Placed on Anticoagulation After Cardiology Appointment

    Time frame: up to 6 months

    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.

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • Pfizer

Registry information

Official study title

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

Acronym: AFib 2gether

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 8, 2019
Registry last updated
May 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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