NCT04045639
Completed
Not Applicable
A Randomised Controlled Trial for the Identification of Undiagnosed Atrial Fibrillation Patients Using a Machine Learning Risk Prediction Algorithm and Diagnostic Test
ConditionsAtrial Fibrillation
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 260
- Locations
- 1
- Primary Endpoint
- Percentage of participants with diagnosed Atrial Fibrillation during the research window in control and intervention arms
Overview
Brief Summary
This is a trial to assess the effectiveness of an atrial fibrillation (AF) risk prediction algorithm and diagnostic test for the identification of patients with atrial fibrillation
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 30 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Practice inclusion criteria for the trial are as follows;
- •GP Practices within National Institute for Healthcare Research (NIHR) Clinical Research Network: West Midlands (CRN: WM) CRN: WM
- •GP Practices using EMIS as their electronic medical record system of choice. Patient inclusion criteria for the trial are as follows;
- •Patients registered at a participating practice, aged ≥30 years and without an AF diagnosis.
- •Patients with a valid index date (see Section 3.3) Participant inclusion criteria for participation in the intervention arm are;
- •As above, and who have provided written consent to: attend a research clinic, AF diagnosis check using a 12-lead ECG, and for access to medical records Participant inclusion criteria for participation in further AF remote diagnosis with an AliveCor Heart Monitor are;
- •As above, and those with a negative or indeterminant ECG
- •As above, and those with access to a smartphone
- •Exclusion criteria:
- •Patients \<30 years
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Percentage of participants with diagnosed Atrial Fibrillation during the research window in control and intervention arms
Time Frame: From the first collection of patient medical records at the beginning of the trial to the last collection of patient records following the intervention at the end of the trial (Up to 6 months)
Prevalence of AF in the research window assessed
Secondary Outcomes
- Expected healthcare resource utilisation (Annual maintenance costs related to health states (informed by the primary endpoint), and daily treatment costs (including monitoring))(Up to 6 months)
- Quality-adjusted life years (QALYs)(Up to 6 months)
- Life years (LYs)(Up to 6 months)
Investigators
Study Sites (1)
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