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Shared Decision-Making: AFib 2gether Mobile App (AFib 2gether)

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ClinicalTrials.gov Identifier: NCT04118270
Recruitment Status : Completed
First Posted : October 8, 2019
Last Update Posted : August 13, 2020
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Alok Kapoor, University of Massachusetts, Worcester

Study Description
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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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation New Onset Device: Afib 2gether TM Mobile Application Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Shared Decision-Making: Implementing the AFib 2getherTM Mobile App
Actual Study Start Date : November 1, 2019
Actual Primary Completion Date : June 26, 2020
Actual Study Completion Date : June 26, 2020

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Arms and Interventions
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Arm Intervention/treatment
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Use of the AFib 2gether app during cardiology visits to facilitate treatment discussion and plans for anticoagulation therapy [ Time Frame: Immediately after visit ]
    Patient/Provider interactions will be recorded in an encrypted manner and then encoded for mention/use or absence of discussion of the application within the interaction to indicate use or nonuse of the application. A high score indicates high overall usage and a low score indicates low overall usage.


Secondary Outcome Measures :
  1. Concurrence of Provider Risk Assessment and App Risk Assessment for Stroke. [ Time Frame: Immediately after visit. ]
    The patient's cardiovascular provider will be queried to assess whether the patient's risk score as calculated by the app correlates with the provider's own assessment of patient risk. This feedback is obtained through a post-visit questionnaire which includes questions about app impressions including accuracy of score. A positive score will indicate that the app risk score matched the provider's risk score, and a negative score will indicate that the app score did not match the provider's risk score.

  2. Impact of provider knowledge on stroke risk and atrial fibrillation to utility of app to guide clinical decision making [ Time Frame: Immediately after visit ]
    The patient's cardiovascular provider will be evaluated on knowledge of stroke risk and atrial fibrillation treatment options prior to patient visit, and then asked to assess whether or not the application was useful in the clinical decision-making process related to placing the patient on anti-coagulation therapy. If the application was used by provider and patient during treatment discussion, the provider is asked to rank the utility of the application and to indicate on a scale of "strongly disagree", "somewhat disagree", "neutral", "somewhat agree" and "Strongly Agree" to if the app was helpful in making this determination. Answers closer to the strongly agree side will indicate perceived usefulness of the application. If the answers are closer to the strongly disagree side, this will indicate that the app was less useful.


Other Outcome Measures:
  1. Anticoagulation status of patients pre and post status cardiology visit as determined by the CHA2DS2-VASc2 score. [ Time Frame: up to 12 months ]
    Whether the patient's cardiovascular provider places the patient on anticoagulation therapy due to a sufficiently high CHA2DS2-VASc2 score as identified by the app and the provider. Additionally, we will be testing if there is agreement between the CHA2DS2-VASc2 score determined by the application and the cardiology provider.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04118270


Locations
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United States, Massachusetts
UMass Medical School
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts, Worcester
Pfizer
Investigators
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Principal Investigator: Alok Kapoor, MD UMass Medical School
  Study Documents (Full-Text)

Documents provided by Alok Kapoor, University of Massachusetts, Worcester:
Study Protocol  [PDF] April 3, 2020
Statistical Analysis Plan  [PDF] August 10, 2020

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Alok Kapoor, Associate Professor, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT04118270    
Other Study ID Numbers: H00018053
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: August 13, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes