Screening for Atrial Fibrillation With Self Pulse Monitoring

Atrial Fibrillation New Onset Clinical Trial

Official title:

Screening for Atrial Fibrillation With Self Pulse Monitoring in Patients at Increased Risk of Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05818592
• Other study ID #: 19-2254
• Status: Completed
• Phase: N/A
• Start date: September 21, 2020
• Est. completion date: May 31, 2022

Study information

• Verified date: April 2023
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 526
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation New Onset

Intervention

Other:
• Self-Pulse Monitoring
Participants will manually monitor pulse for irregularities.

Locations

Country	Name	City	State
United States	University of North Carolina, Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Bristol-Myers Squibb Foundation

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

Freedman B, Camm J, Calkins H, Healey JS, Rosenqvist M, Wang J, Albert CM, Anderson CS, Antoniou S, Benjamin EJ, Boriani G, Brachmann J, Brandes A, Chao TF, Conen D, Engdahl J, Fauchier L, Fitzmaurice DA, Friberg L, Gersh BJ, Gladstone DJ, Glotzer TV, Gwynne K, Hankey GJ, Harbison J, Hillis GS, Hills MT, Kamel H, Kirchhof P, Kowey PR, Krieger D, Lee VWY, Levin LA, Lip GYH, Lobban T, Lowres N, Mairesse GH, Martinez C, Neubeck L, Orchard J, Piccini JP, Poppe K, Potpara TS, Puererfellner H, Rienstra M, Sandhu RK, Schnabel RB, Siu CW, Steinhubl S, Svendsen JH, Svennberg E, Themistoclakis S, Tieleman RG, Turakhia MP, Tveit A, Uittenbogaart SB, Van Gelder IC, Verma A, Wachter R, Yan BP; AF-Screen Collaborators. Screening for Atrial Fibrillation: A Report of the AF-SCREEN International Collaboration. Circulation. 2017 May 9;135(19):1851-1867. doi: 10.1161/CIRCULATIONAHA.116.026693. — View 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. — View 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. — View 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. — View Citation

US Preventive Services Task Force; Curry SJ, Krist AH, Owens DK, Barry MJ, Caughey AB, Davidson KW, Doubeni CA, Epling JW Jr, Kemper AR, Kubik M, Landefeld CS, Mangione CM, Silverstein M, Simon MA, Tseng CW, Wong JB. Screening for Atrial Fibrillation With Electrocardiography: US Preventive Services Task Force Recommendation Statement. JAMA. 2018 Aug 7;320(5):478-484. doi: 10.1001/jama.2018.10321. — View Citation

Yaghi S, Kamel H. Stratifying Stroke Risk in Atrial Fibrillation: Beyond Clinical Risk Scores. Stroke. 2017 Oct;48(10):2665-2670. doi: 10.1161/STROKEAHA.117.017084. Epub 2017 Sep 15. No abstract available. Erratum In: Stroke. 2017 Dec;48(12 ):e368. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants diagnosed with AF in intervention group who screened positive.	Participants assigned to the intervention group are instructed on how to manually check their pulse to detect irregularities. Those who screen positive for irregularities will be sent a 14-day wearable cardiac monitor to confirm diagnosis of AF. Diagnosis of AF can also be confirmed by electrocardiogram (ECG) at an outpatient clinic visit.	6 weeks
Secondary	Total number of participants diagnosed with AF	Participant data will be collected from the electronic health record one year after randomization to assess how many participants from each arm are subsequently diagnosed with AF.	1-year
Secondary	Amount of time in days to diagnosis of AF from randomization	Participant data will be collected from the electronic health record one year after randomization to assess how many participants from each arm are subsequently diagnosed with AF. For participants with a diagnosis of AF, the time in days from randomization to diagnosis will be calculated.	1-year
Secondary	Number of participants prescribed anticoagulation	Participant data will be collected from the electronic health record one year after randomization to assess how many participants are prescribed anticoagulation medications.	1-year
Secondary	Number of participants with stroke, transient ischemic attack (TIA), or systemic embolism	Participant data will be collected from the electronic health record one year after randomization to assess how many participants have a diagnosis of stroke, TIA, or systemic embolism.	1-year