Shared Decision-Making: AFib 2gether Mobile App

NCT04118270 | Completed Results FDA Device

• 1 other identifier: H00018053
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation New Onset

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Provider MARS Scores

  Immediately after visit.

• Reason Why the Patient Was Not on AC Prior to Their Appointment

  Immediately after visit

• Afib 2gether Accuracy Assessment

  Immediately after visit.

Other Outcomes (1)

• Number of Patients Placed on Anticoagulation After Cardiology Appointment

  up to 6 months

Study Arms (1)

AFib 2gether(TM) App

EXPERIMENTAL

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

Interventions

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.

AFib 2gether(TM) App

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Pfizer: collaborator

Study Sites (1)

UMass Medical School

Worcester, Massachusetts, 01655, United States

Location

Related Publications (2)

• 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.

  PMID: 34806997 DERIVED

• 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.

  PMID: 33625361 DERIVED

Results Point of Contact

• Title: Alok Kapoor
• Organization: University of Massachusetts Medical School

alok.kapoor@umassmed.edu

917-856-4538

Study Officials

• Alok Kapoor, MD

  UMass Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 8, 2019
• Study Start: November 1, 2019
• Primary Completion: June 26, 2020
• Study Completion: June 26, 2020
• Last Updated: May 2, 2022
• Results First Posted: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)