---
title: "Shared Decision-Making: AFib 2gether Mobile App"
nct_id: NCT04118270
overall_status: COMPLETED
phase: NA
sponsor: University of Massachusetts, Worcester
study_type: INTERVENTIONAL
primary_condition: Atrial Fibrillation New Onset
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04118270.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04118270"
ct_last_update_post_date: 2022-05-02
last_seen_at: "2026-05-12T06:19:01.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Shared Decision-Making: AFib 2gether Mobile App

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

**NCT ID:** [NCT04118270](https://clinicaltrials.gov/study/NCT04118270)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 50
- **Lead Sponsor:** University of Massachusetts, Worcester
- **Collaborators:** Pfizer
- **Conditions:** Atrial Fibrillation New Onset
- **Start Date:** 2019-11-01
- **Completion Date:** 2020-06-26
- **CT.gov Last Update:** 2022-05-02

## 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

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **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.

## 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.

## Primary Outcomes

- **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

- **Provider MARS Scores** _(time frame: Immediately after visit.)_
- **Reason Why the Patient Was Not on AC Prior to Their Appointment** _(time frame: Immediately after visit)_
- **Afib 2gether Accuracy Assessment** _(time frame: Immediately after visit.)_

## Locations (1)

- UMass Medical School, Worcester, Massachusetts, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.umass medical school|worcester|massachusetts|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04118270.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04118270*  
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