ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
Adult Trials: 18+ Years
Providers:
- Caring for at least 3 patients aged 18 years and older
- Have at least 3 patients with ICD-10 diagnostic code consistent with 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 ACC cardiology appointment in the past 12 months
- Future appointment in the next 4 months with the same provider
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
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- Worcester, Massachusetts
| Descriptive Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | Shared Decision-Making: AFib 2gether Mobile App | ||||||||
| Official Title ICMJE | Shared Decision-Making: Implementing the AFib 2getherTM Mobile App | ||||||||
| 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. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Device Feasibility | ||||||||
| Condition ICMJE | Atrial Fibrillation New Onset | ||||||||
| Intervention ICMJE | Device: Afib 2gether TM Mobile Application
The Afib 2gether mobile app determines a patient's stroke risk through a series of questions that the patient will answer in the app. | ||||||||
| Study Arms ICMJE | Experimental: AFib 2gether(TM) App
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: Device: Afib 2gether TM Mobile Application | ||||||||
| Publications * | 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. | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Actual Enrollment ICMJE | 37 | ||||||||
| Original Estimated Enrollment ICMJE | 48 | ||||||||
| Actual Study Completion Date ICMJE | June 26, 2020 | ||||||||
| Actual Primary Completion Date | June 26, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Providers:
Patients:
Exclusion Criteria: Providers:
Patients:
| ||||||||
| Sex/Gender ICMJE |
| ||||||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04118270 | ||||||||
| Other Study ID Numbers ICMJE | H00018053 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
| ||||||||
| IPD Sharing Statement ICMJE |
| ||||||||
| Responsible Party | Alok Kapoor, University of Massachusetts, Worcester | ||||||||
| Study Sponsor ICMJE | University of Massachusetts, Worcester | ||||||||
| Collaborators ICMJE | Pfizer | ||||||||
| Investigators ICMJE |
| ||||||||
| PRS Account | University of Massachusetts, Worcester | ||||||||
| Verification Date | August 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||||