Shared Decision-Making: AFib 2gether Mobile App

University of Massachusetts, Worcester

Status: Completed

Conditions: Atrial Fibrillation New Onset

Treatments: Device: Afib 2gether TM Mobile Application

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04118270

H00018053

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

AFib 2gether(TM) App

Experimental group

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.

Treatment:

Device: Afib 2gether TM Mobile Application