Home-Based Screening for Early Detection of Atrial Fibrillation in Primary Care Patients Aged 75 Years and Older
NCT ID: NCT02392754
Last Updated: 2020-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
856 participants
INTERVENTIONAL
2015-04-01
2020-01-21
Brief Summary
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Detailed Description
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* The control group will receive standard care for 6 months (including a pulse check and heart auscultation by a physician at baseline and 6 months).
* The intervention group will undergo ambulatory screening for AF with a 2-week continuous ECG patch monitor worn at baseline and again at 3 months, in addition to standard care for 6 months (including a pulse check and heart auscultation by a physician at baseline and 6 months). The intervention group will also receive a home BP monitor with automatic AF detection capability to be used twice daily for 2 weeks during the ECG monitoring blocks.
The hypothesis is that continuous ambulatory cardiac rhythm monitoring using an adhesive ECG patch monitor will be superior to standard care for AF detection. The overall aim of this research is to establish a practical and cost-effective screening strategy that could be applied in primary care for early detection of AF in patients who would benefit from anticoagulant therapy if AF were detected. The ultimate goal of this primary prevention initiative is to prevent more strokes, and stroke-related deaths, disability, dementia, hospitalizations and institutionalization, through the early detection and treatment of AF.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Screening
The intervention group receives AF screening with a 2-week ambulatory ECG patch monitor (ZIO XT Patch) worn at baseline and again at 3 months, in addition to standard care for 6 months. The intervention group also receives a home BP monitor with automatic AF detection capability to be used twice daily for 2 weeks during the ECG monitoring periods.
Screening: Intervention - Atrial fibrillation screening (ZIO XT ECG monitor, Watch-BP)
The intervention group receives AF screening with a 2-week ambulatory ECG patch monitor (ZIO XT Patch) worn at baseline and again at 3 months, in addition to standard care for 6 months. The intervention group also receives a home BP monitor with automatic AF detection capability to be used twice daily for 2 weeks during the ECG monitoring periods.
Control
The control group receives standard care for 6 months (including a pulse check and heart auscultation by a physician at 6 months).
No interventions assigned to this group
Interventions
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Screening: Intervention - Atrial fibrillation screening (ZIO XT ECG monitor, Watch-BP)
The intervention group receives AF screening with a 2-week ambulatory ECG patch monitor (ZIO XT Patch) worn at baseline and again at 3 months, in addition to standard care for 6 months. The intervention group also receives a home BP monitor with automatic AF detection capability to be used twice daily for 2 weeks during the ECG monitoring periods.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. The participant is clinically in sinus rhythm (both heart auscultation and 30- second pulse palpation have been performed by the enrolling physician and neither detects an irregular rhythm suggestive of atrial fibrillation).
3. History of hypertension requiring antihypertensive medication.
4. Written informed consent from the participant.
Exclusion Criteria
2. Implanted pacemaker, cardiac defibrillator, cardiac loop recorder, or deep brain stimulator.
3. Likely to be poorly compliant or unreliable using home screening devices or with study follow-up requirements because of cognitive or other issues, or life expectancy \<6 months due to concomitant disease.
4. Has a condition which in the opinion of the enrolling physician would not permit chronic treatment with oral anticoagulant therapy.
5. Patient already taking long-term oral anticoagulant therapy.
6. Known allergic reaction/intolerance to skin adhesives.
75 Years
ALL
Yes
Sponsors
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Canadian Stroke Prevention Intervention Network
OTHER
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Heart and Stroke Foundation of Canada
OTHER
Canadian Stroke Network
OTHER
iRhythm Technologies, Inc.
INDUSTRY
Microlife
INDUSTRY
University of Leipzig
OTHER
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
OTHER
Population Health Research Institute
OTHER
Responsible Party
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Principal Investigators
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David J. Gladstone, MD PhD FRCPC
Role: PRINCIPAL_INVESTIGATOR
Sunnybrook Research Institute, University of Toronto
Locations
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Crowfoot Village Family Practice
Calgary, Alberta, Canada
Smith Clinic
Camrose, Alberta, Canada
Edmonton Oliver PCN
Edmonton, Alberta, Canada
Peaks to Praries PCN
Olds, Alberta, Canada
Henry Vlaar FP
Ayr, Ontario, Canada
LMC / Manna Research
Burlington, Ontario, Canada
Humber River FHT - Dixon Site
Etobicoke, Ontario, Canada
Halton Hills FHT
Georgetown, Ontario, Canada
Haileybury FHT
Haileybury, Ontario, Canada
Hamilton Medical Clinic
Hamilton, Ontario, Canada
Queen's Family Health Team
Kingston, Ontario, Canada
Ken Ng FP / Total Health Management
Markham, Ontario, Canada
St. Lawrence Medical Clinic
Morrisburg, Ontario, Canada
SKDS Research Inc.
Newmarket, Ontario, Canada
OakMed FHT
Oakville, Ontario, Canada
Mark Robertson Family Practice
Owen Sound, Ontario, Canada
Garden City FHT
Saint Catherines, Ontario, Canada
Michael Kopp Family Practice / N Fung & M Kopp Medicine Professional Corporation
St. Catharines, Ontario, Canada
Health for All FHT
Stouffville, Ontario, Canada
Port Arthur Health Centre
Thunder Bay, Ontario, Canada
Keele Medical Place
Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Women's College Hospital
Toronto, Ontario, Canada
Mount Dennis Weston Health Centre
Toronto, Ontario, Canada
Sameh Fikry Medicine Professional Corporation
Waterloo, Ontario, Canada
Goethe University Frankfurt am Main
Frankfurt am Main, , Germany
Universitätsmedizin Göttingen
Göttingen, , Germany
Hamburg University Medical School
Hamburg, , Germany
Countries
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References
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Gladstone DJ, Wachter R, Schmalstieg-Bahr K, Quinn FR, Hummers E, Ivers N, Marsden T, Thornton A, Djuric A, Suerbaum J, von Grunhagen D, McIntyre WF, Benz AP, Wong JA, Merali F, Henein S, Nichol C, Connolly SJ, Healey JS; SCREEN-AF Investigators and Coordinators. Screening for Atrial Fibrillation in the Older Population: A Randomized Clinical Trial. JAMA Cardiol. 2021 May 1;6(5):558-567. doi: 10.1001/jamacardio.2021.0038.
Related Links
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This website explains the SCREEN AF study and the C-SPIN network
Other Identifiers
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SCREEN-AF
Identifier Type: -
Identifier Source: org_study_id
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