Clinical trial NCT04118270: Shared Decision-Making: AFib 2gether Mobile App
Official title: Shared Decision-Making: Implementing the AFib 2getherTM Mobile App
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation New Onset
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2019-10-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


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

Primary outcomes:
measure: Patient MARS Scores
timeFrame: Immediately after visit
Secondary outcomes:
measure: Provider MARS Scores
timeFrame: Immediately after visit.
measure: Reason Why the Patient Was Not on AC Prior to Their Appointment
timeFrame: Immediately after visit
measure: Afib 2gether Accuracy Assessment
timeFrame: Immediately after visit.
Other outcomes:
measure: Number of Patients Placed on Anticoagulation After Cardiology Appointment
timeFrame: up to 6 months
Locations:
city: Worcester
country: United States
facility: UMass Medical School
state: Massachusetts
Study officials:
affiliation: UMass Medical School
name: Alok Kapoor, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.