Home-Based Screening for Early Detection of Atrial Fibrillation in Primary Care Patients Aged 75 Years and Older (SCREEN-AF)

Program for Identification of "Actionable" Atrial Fibrillation (PIAAF): Home-Based Screening for Early Detection of Atrial Fibrillation in Primary Care Patients Aged 75 Years and Older: the SCREEN-AF Randomized Trial

Atrial fibrillation (AF) is a major treatable risk factor for stroke, but it may be hard to detect because it is frequently silent and intermittent. New ambulatory cardiac monitoring technologies have the potential to improve early detection of AF. This trial investigates AF screening in primary care patients using the ZIO XT Patch, a wearable adhesive patch monitor that provides continuous ECG recording for up to 14 days, in addition to the WatchBP home blood pressure monitor that has built-in AF screening capability.

Study Overview

• Status: Completed
• Conditions: Hypertension; Atrial Fibrillation
• Intervention / Treatment: Device: Screening: Intervention - Atrial fibrillation screening (ZIO XT ECG monitor, Watch-BP)

Detailed Description

SCREEN-AF is an investigator-initiated, multicenter, open-label, two-group randomized controlled trial investigating non-invasive, home-based AF screening. The trial targets patients aged 75 years or older with a history of hypertension and without known AF who would be potential anticoagulant candidates if AF were detected. Eligible participants will be recruited from primary care practices and randomly allocated (1:1) to one of two groups:

• 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.

• Study Type: Interventional
• Enrollment (Actual): 856
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3G 0B4
      • Crowfoot Village Family Practice
    • Camrose, Alberta, Canada
      • Smith Clinic
    • Edmonton, Alberta, Canada, T5H 3V9
      • Edmonton Oliver PCN
    • Olds, Alberta, Canada, T4H 1B8
      • Peaks to Praries PCN
  • Ontario
    • Ayr, Ontario, Canada, N0B 1E0
      • Henry Vlaar FP
    • Burlington, Ontario, Canada, L7R 1E2
      • LMC / Manna Research
    • Etobicoke, Ontario, Canada, M9P
      • Humber River FHT - Dixon Site
    • Georgetown, Ontario, Canada, L7G 4A1
      • Halton Hills FHT
    • Haileybury, Ontario, Canada, P0J 1K0
      • Haileybury FHT
    • Hamilton, Ontario, Canada, L8J 0B6
      • Hamilton Medical Clinic
    • Kingston, Ontario, Canada, K7L 5E9
      • Queen's Family Health Team
    • Markham, Ontario, Canada, L3P 5T7
      • Ken Ng FP / Total Health Management
    • Morrisburg, Ontario, Canada, K0C 1X0
      • St. Lawrence Medical Clinic
    • Newmarket, Ontario, Canada, L3Y 5G8
      • SKDS Research Inc.
    • Oakville, Ontario, Canada, L6H 7S8
      • OakMed FHT
    • Owen Sound, Ontario, Canada, N4K 4K8
      • Mark Robertson Family Practice
    • St. Catharines, Ontario, Canada, L2N 4V5
      • Michael Kopp Family Practice / N Fung & M Kopp Medicine Professional Corporation
    • St. Catherines, Ontario, Canada, L2R 1R5
      • Garden City FHT
    • Stouffville, Ontario, Canada, L6B 0T1
      • Health for All FHT
    • Thunder Bay, Ontario, Canada, P7A 4V7
      • Port Arthur Health Centre
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
    • Toronto, Ontario, Canada, M5S 1B2
      • Women's College Hospital
    • Toronto, Ontario, Canada, M3M 3E5
      • Keele Medical Place
    • Toronto, Ontario, Canada, M6N 4N6
      • Mount Dennis Weston Health Centre
    • Waterloo, Ontario, Canada, N2J 1C4
      • Sameh Fikry Medicine Professional Corporation
• Germany
  • Frankfurt am Main, Germany
    • Goethe University Frankfurt am Main
  • Göttingen, Germany
    • Universitätsmedizin Göttingen
  • Hamburg, Germany
    • Hamburg University Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 71 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥75 years without known atrial fibrillation or atrial flutter.
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:

1. Any previously documented atrial fibrillation or atrial flutter ≥30 seconds.
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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 Names: ZIO XT Patch ambulatory ECG patch monitor; Watch BP-Home A blood pressure monitor
No Intervention: Control; The control group receives standard care for 6 months (including a pulse check and heart auscultation by a physician at 6 months).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of new atrial fibrillation or flutter	Detection of new AF (atrial fibrillation or atrial flutter) within 6 months post-randomization, with AF defined as at least one episode of continuous AF lasting >5 minutes or AF documented on at least one 12-lead ECG or a convincing clinical diagnosis of AF based on reliable source documentation.	within 6 month from randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prescription of oral anticoagulation therapy	Oral anticoagulant therapy use at 3 and 6 months post-randomization.	within 6 months from randomization
Primary endpoint detected by ECG patch monitor	Among intervention group patients that meet the primary endpoint, detected by the ECG patch monitor, the following criteria will be analyzed: time to first detection of AF >5 minutes; daily and total AF burden; average duration per AF episode.	within 6 months from randomization
Atrial fibrillation episodes of various durations (detection of any AF episode ≥30 seconds, ≥30 seconds to 5 minutes, >5 hours, and >24 hours (to facilitate comparison with other studies in the literature)	Among intervention group patients, detection of any AF episode ≥30 seconds, ≥30 seconds to 5 minutes, >5 hours, and >24 hours (to facilitate comparison with other studies in the literature).	within 6 months from randomization
Adherence, tolerability and patient satisfaction with screening devices	This is a composite outcome measured by the following: Patient adherence with the screening devices (defined as the average number of monitoring days completed and reasons for non-adherence); Patient satisfaction with the screening devices (as measured by user satisfaction surveys), - Tolerability of the ECG monitor (defined as the incidence of adverse skin reactions related to the adhesive patch).	within 6 months of randomization
Clinical outcome events	A clinical outcome event will be defined as one of the following: ischemic stroke; TIA; systemic embolism; major bleeding; intracranial hemorrhage; physician visits; hospitalizations; medication prescriptions. Clinical outcome events will be captured within 6 months post-randomization. The outcome is a composite measure.	within 6 months from randomization
Cost effectiveness of screening	The cost effectiveness of screening is a composite outcome. The outcome will be measured by cost-effectiveness (cost per life year saved) and cost-utility (cost per quality adjusted life year (QALY) gained) of AF screening.	within 6 months from randomization
Detection of other (non-AF) clinically important arrhythmias	Detection of other potentially clinically important non-AF arrhythmias: atrial tachycardia, pause >3 seconds, high-grade atrioventricular block (Mobitz type II or third-degree AV block), ventricular tachycardia, polymorphic ventricular tachycardia/ventricular fibrillation.	within 6 months from randomization
Sensitivity and specificity of Watch BP Home-A monitor ( false positive rate of a home AF-BP monitor (with ECG patch monitor as the gold standard).	Estimated sensitivity, specificity and false positive rate of a home AF-BP monitor (with ECG patch monitor as the gold standard).	within 6 months from randomization

Collaborators and Investigators

• Sponsor: Population Health Research Institute
• Collaborators: Canadian Institutes of Health Research (CIHR); University of Leipzig; Heart and Stroke Foundation of Canada; Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK); Canadian Stroke Network; Canadian Stroke Prevention Intervention Network; iRhythm Technologies, Inc.; Microlife
• Investigators: Principal Investigator: David J. Gladstone, MD PhD FRCPC, Sunnybrook Research Institute, University of Toronto

Publications and helpful links

General Publications

• 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.

Helpful Links

• This website explains the SCREEN AF study and the C-SPIN network

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): October 21, 2019
• Study Completion (Actual): January 21, 2020

Study Registration Dates

• First Submitted: January 19, 2015
• First Submitted That Met QC Criteria: March 13, 2015
• First Posted (Estimate): March 19, 2015

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 22, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Primary care; Screening; ECG
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: SCREEN-AF