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
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation New Onset||Device: Afib 2gether TM Mobile Application||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|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|
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.
- 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.
- 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.
- 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.
- 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.
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
|United States, Massachusetts|
|UMass Medical School|
|Worcester, Massachusetts, United States, 01655|
|Principal Investigator:||Alok Kapoor, MD||UMass Medical School|