Study Results
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View full resultsBasic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2019-11-01
2020-06-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
University of Massachusetts, Worcester
OTHER
Responsible Party
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Alok Kapoor
Associate Professor
Principal Investigators
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Alok Kapoor, MD
Role: PRINCIPAL_INVESTIGATOR
UMass Medical School
Locations
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UMass Medical School
Worcester, Massachusetts, United States
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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H00018053
Identifier Type: -
Identifier Source: org_study_id
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