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

Primary Purpose

Atrial Fibrillation New Onset

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Afib 2gether TM Mobile Application
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Atrial Fibrillation New Onset

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UMass Medical School

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AFib 2gether(TM) App

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
October 3, 2019
Last Updated
March 30, 2022
Sponsor
University of Massachusetts, Worcester
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT04118270
Brief Title
Shared Decision-Making: AFib 2gether Mobile App
Acronym
AFib 2gether
Official Title
Shared Decision-Making: Implementing the AFib 2getherTM Mobile App
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
June 26, 2020 (Actual)
Study Completion Date
June 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester
Collaborators
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation New Onset

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AFib 2gether(TM) App
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Afib 2gether TM Mobile Application
Intervention Description
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 Outcome Measure Information:
Title
Patient MARS Scores
Description
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.
Time Frame
Immediately after visit
Secondary Outcome Measure Information:
Title
Provider MARS Scores
Description
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.
Time Frame
Immediately after visit.
Title
Reason Why the Patient Was Not on AC Prior to Their Appointment
Description
This was an evaluation of why the patient was not on an anticoagulant (AC) prior to their appointment.
Time Frame
Immediately after visit
Title
Afib 2gether Accuracy Assessment
Description
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.
Time Frame
Immediately after visit.
Other Pre-specified Outcome Measures:
Title
Number of Patients Placed on Anticoagulation After Cardiology Appointment
Description
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.
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alok Kapoor, MD
Organizational Affiliation
UMass Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMass Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34806997
Citation
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.
Results Reference
derived
PubMed Identifier
33625361
Citation
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.
Results Reference
derived

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Shared Decision-Making: AFib 2gether Mobile App

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