Screening for Atrial Fibrillation With Self Pulse Monitoring

NCT05818592 | Completed

• 1 other identifier: 19-2254
• Study Type: interventional
• Target: 526
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation New Onset

Keywords

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Total number of participants diagnosed with AF

  1-year

• Amount of time in days to diagnosis of AF from randomization

  1-year

• Number of participants prescribed anticoagulation

  1-year

• Number of participants with stroke, transient ischemic attack (TIA), or systemic embolism

  1-year

Study Arms (2)

Self-Pulse Monitoring Intervention Group

EXPERIMENTAL

Participants view an educational video instructing them on how to manually check their pulse for irregularities. Participants will be instructed to check their pulse for 30 seconds twice daily for 2 weeks.

Other: Self-Pulse Monitoring

Control Group Standard of Care

NO INTERVENTION

The control group will continue with usual care.

Interventions

Self-Pulse Monitoring OTHER

Participants will manually monitor pulse for irregularities.

Self-Pulse Monitoring Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (7)

• 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.

  PMID: 30088016 BACKGROUND

• 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.

  PMID: 28916670 BACKGROUND

• 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.

  PMID: 28483832 BACKGROUND

• 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.

  PMID: 29998336 BACKGROUND

• 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.

  PMID: 25910800 BACKGROUND

• 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.

  PMID: 23343564 BACKGROUND

• 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.

  PMID: 23595785 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anil Gehi, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible participants will be randomized to either the intervention group or control group.

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: April 19, 2023
• Study Start: September 21, 2020
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Deidentified individual data that supports the results will be shared beginning 12 to 36 months following publication.
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)