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Screening for Atrial Fibrillation With Self Pulse Monitoring

Primary Purpose

Atrial Fibrillation New Onset

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-Pulse Monitoring
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation New Onset focused on measuring Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of North Carolina, Chapel Hill

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Self-Pulse Monitoring Intervention Group

Control Group Standard of Care

Arm Description

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.

The control group will continue with usual care.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
April 4, 2023
Last Updated
April 4, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT05818592
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 21, 2020 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation New Onset
Keywords
Atrial Fibrillation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Eligible participants will be randomized to either the intervention group or control group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
526 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-Pulse Monitoring Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group Standard of Care
Arm Type
No Intervention
Arm Description
The control group will continue with usual care.
Intervention Type
Other
Intervention Name(s)
Self-Pulse Monitoring
Intervention Description
Participants will manually monitor pulse for irregularities.
Primary Outcome Measure Information:
Title
Number of participants diagnosed with AF in intervention group who screened positive.
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Total number of participants diagnosed with AF
Description
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.
Time Frame
1-year
Title
Amount of time in days to diagnosis of AF from randomization
Description
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.
Time Frame
1-year
Title
Number of participants prescribed anticoagulation
Description
Participant data will be collected from the electronic health record one year after randomization to assess how many participants are prescribed anticoagulation medications.
Time Frame
1-year
Title
Number of participants with stroke, transient ischemic attack (TIA), or systemic embolism
Description
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.
Time Frame
1-year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anil Gehi, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina, Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified individual data that supports the results will be shared beginning 12 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
IPD Sharing Time Frame
Deidentified individual data that supports the results will be shared beginning 12 to 36 months following publication.
IPD Sharing Access Criteria
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
Citations:
PubMed Identifier
30088016
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
28483832
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.
Results Reference
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PubMed Identifier
29998336
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.
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Citation
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Citation
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Screening for Atrial Fibrillation With Self Pulse Monitoring

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