Shared Decision-Making: AFib 2gether Mobile App

NCT04118270

Last updated date
Study Location
UMass Medical School
Worcester, Massachusetts, 01655, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Atrial Fibrillation New Onset
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Atrial Fibrillation New OnsetShared Decision-Making: AFib 2gether Mobile App
NCT04118270
  1. Worcester, Massachusetts
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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 * Not Provided

*   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
 (submitted: August 5, 2020)
37
Original Estimated Enrollment  ICMJE
 (submitted: October 4, 2019)
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:

  • 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

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Alok Kapoor, University of Massachusetts, Worcester
Study Sponsor  ICMJE University of Massachusetts, Worcester
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Alok Kapoor, MDUMass Medical School
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