Clinical trial NCT05818592: Screening for Atrial Fibrillation With Self Pulse Monitoring
Official title: Screening for Atrial Fibrillation With Self Pulse Monitoring in Patients at Increased Risk of Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation New Onset
Keywords: Atrial Fibrillation
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2023-04-19
Enrollment: 526
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible participants will be randomized to either the intervention group or control group.
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this clinical trial is to determine the efficacy of self-pulse monitoring in detecting atrial fibrillation (AF) in adult patients at increased risk of stroke.

The main questions it aims to answer are:

* Is self-screening an effective modality for diagnosis of AF?
* Are there clinical differences and outcomes for patients who self-screen?

Eligible participants will be randomized to either the intervention group or control group. The control group will continue with usual standard of care. Participants randomized to the intervention group will be asked to:

* View an online educational video to teach them the appropriate way to manually check their pulse for irregularities.
* Manually check their pulse for 30 seconds twice daily for 14 days.
* Patients who screen positive for irregularities will be sent a 14-day wearable cardiac monitor to assess for underlying arrhythmias.

Researchers will compare the intervention group to the control group to see if there are clinical differences and outcomes.

Detailed description: Participants will be recruited for this study using MyChart recruiting. Participants meeting inclusion criteria will be invited to participate and can respond "interested" or "decline." Participants who respond interested will complete a brief survey to confirm eligibility prior to consenting. One the participant consents, they will be randomized to the self-pulse check/intervention group or control group.

Eligibility criteria: Inclusion Criteria:

* Age 18 or greater
* No known history of atrial fibrillation or atrial flutter
* Access to MyChart
* CHA2DS2-VASc sore (described below) \>/= 2 (male) or \>/=3 (female) based on the following criteria:

  * Two points: Age ≥75, prior stroke
  * One point: Age ≥65-74, congestive heart failure, hypertension, diabetes, vascular disease

Exclusion Criteria:

* Prior diagnosis of atrial fibrillation or atrial flutter
* Unable to consent
* Currently incarcerated
* Self-pay/uninsured
* Taking anticoagulation for other medical conditions than atrial fibrillation or atrial flutter

Primary outcomes:
measure: Number of participants diagnosed with AF in intervention group who screened positive.
timeFrame: 6 weeks
Secondary outcomes:
measure: Total number of participants diagnosed with AF
timeFrame: 1-year
measure: Amount of time in days to diagnosis of AF from randomization
timeFrame: 1-year
measure: Number of participants prescribed anticoagulation
timeFrame: 1-year
measure: Number of participants with stroke, transient ischemic attack (TIA), or systemic embolism
timeFrame: 1-year
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina, Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Anil Gehi, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Steinhubl SR, Waalen J, Edwards AM, Ariniello LM, Mehta RR, Ebner GS, Carter C, Baca-Motes K, Felicione E, Sarich T, Topol EJ. Effect of a Home-Based Wearable Continuous ECG Monitoring Patch on Detection of Undiagnosed Atrial Fibrillation: The mSToPS Randomized Clinical Trial. JAMA. 2018 Jul 10;320(2):146-155. doi: 10.1001/jama.2018.8102.
citation: Svennberg E, Engdahl J, Al-Khalili F, Friberg L, Frykman V, Rosenqvist M. Mass Screening for Untreated Atrial Fibrillation: The STROKESTOP Study. Circulation. 2015 Jun 23;131(25):2176-84. doi: 10.1161/CIRCULATIONAHA.114.014343. Epub 2015 Apr 24.
citation: Engdahl J, Andersson L, Mirskaya M, Rosenqvist M. Stepwise screening of atrial fibrillation in a 75-year-old population: implications for stroke prevention. Circulation. 2013 Feb 26;127(8):930-7. doi: 10.1161/CIRCULATIONAHA.112.126656. Epub 2013 Jan 23.
citation: Lowres N, Neubeck L, Redfern J, Freedman SB. Screening to identify unknown atrial fibrillation. A systematic review. Thromb Haemost. 2013 Aug;110(2):213-22. doi: 10.1160/TH13-02-0165. Epub 2013 Apr 18.