Hong Kong Outpatient AF Screening Using Single-lead ECG Device
NCT ID: NCT02409654
Last Updated: 2021-10-19
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
500 participants
INTERVENTIONAL
2015-01-01
2019-09-30
Brief Summary
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Detailed Description
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The study consists of 2 stages. The screening study examines the feasibility of screening to identify undiagnosed AF in the elderly (\>=65 years) using a validated hand-held ECG device and the impact of screening on clinical and economic outcomes at the population level. Subsequent intervention study is a randomized-controlled study comparing an individualized stroke prevention strategy with routine care to prevent stroke in screen-detected AF patients.
Stage 1: AF Screening Study
Screening will be performed in 2 Cardiology and 4 Family Medicine Specialty Out-Patient Clinics (SOPC) at a tertiary referral hospital in Hong Kong. Subjects who meet inclusion and exclusion criteria will sign informed consent for Stage 1 and 2 studies separately, prior to conducting ECG screening.
Stage 2: Randomized Study of Individualized Stroke Prevention vs. Routine Care
Intervention
Screen detected AF patients (new or known AF) from Stage 1 who are not already receiving appropriate OAC for stroke prevention who signed informed consent are randomized 1:1 to routine care or an individualized stroke prevention strategy. Participants will be randomized using block randomization method to assure both groups have the same number of subjects.
Individualized Stroke Prevention Strategy
(i) Patient education on AF and stroke risk. (ii) Assess individual risk of stroke using the CHADS2 and CHA2DS2VASc score and risk of major bleeding using the HAS-BLED score (iii) Recommendation of evidence-based stroke prevention therapy (iv) Patient audit and follow-up: Patients not on appropriate OAC without adequate explanation will be referred to Cardiology SOPC for second opinion.
Routine Care
The iECG tracing and report is provided to the attending doctor. Prescription of OAC is left to the discretion of the attending doctor.
Follow-up
Participants will be followed prospectively every 12 months up to 3 years for clinical events including death, ischemic stroke, any thromboembolic events, intracranial and other major bleeding and stroke prevention therapy. Screen-detected AF patients from Stage 1 who declined to participate in the intervention study will be followed up in a registry.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
SINGLE
Study Groups
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Individualized stroke prevention
(i) Patient education (ii) Assess individual risk of stroke using the CHADS2 and CHA2DS2VASc score and risk of major bleeding using the HAS-BLED score (iii) Recommendation of evidence-based stroke prevention therapy based on international guidelines (iv) Patient audit and follow-up (v) Patients not on appropriate OAC without adequate explanation will be referred to Cardiology Outpatient Clinic for second opinion
Patient education
(i) Patient education (ii) Assess individual risk of stroke using the CHADS2 and CHA2DS2VASc score and risk of major bleeding using the HAS-BLED score (iii) Recommendation of evidence-based stroke prevention therapy based on international guidelines (iv) Patient audit and follow-up (v) Patients not on appropriate OAC without adequate explanation will be referred to Cardiology Outpatient Clinic for second opinion
Routine care
The iECG tracing and report is provided to the attending doctor. Prescription of OAC is left to the discretion of the attending doctor.
Routine Care
The iECG tracing and report is provided to the attending doctor. Prescription of OAC is left to the discretion of the attending doctor.
Routine care
The iECG tracing and report is provided to the attending doctor. Prescription of OAC is left to the discretion of the attending doctor.
Interventions
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Patient education
(i) Patient education (ii) Assess individual risk of stroke using the CHADS2 and CHA2DS2VASc score and risk of major bleeding using the HAS-BLED score (iii) Recommendation of evidence-based stroke prevention therapy based on international guidelines (iv) Patient audit and follow-up (v) Patients not on appropriate OAC without adequate explanation will be referred to Cardiology Outpatient Clinic for second opinion
Routine care
The iECG tracing and report is provided to the attending doctor. Prescription of OAC is left to the discretion of the attending doctor.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Inability to read/understand the consent form and participation information statement
65 Years
ALL
No
Sponsors
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University of Sydney
OTHER
Chinese University of Hong Kong
OTHER
Responsible Party
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Professor Bryan Ping Yen YAN
Associate Professor
Principal Investigators
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Bryan P Yan, MBBS, FACC
Role: PRINCIPAL_INVESTIGATOR
Chinese University of Hong Kong
Locations
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Prince of Wales Hospital
Shatin, New Territories, Hong Kong
Countries
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References
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Camm AJ, Lip GY, De Caterina R, Savelieva I, Atar D, Hohnloser SH, Hindricks G, Kirchhof P; ESC Committee for Practice Guidelines (CPG). 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation. Developed with the special contribution of the European Heart Rhythm Association. Eur Heart J. 2012 Nov;33(21):2719-47. doi: 10.1093/eurheartj/ehs253. Epub 2012 Aug 24. No abstract available.
Mant J, Fitzmaurice DA, Hobbs FD, Jowett S, Murray ET, Holder R, Davies M, Lip GY. Accuracy of diagnosing atrial fibrillation on electrocardiogram by primary care practitioners and interpretative diagnostic software: analysis of data from screening for atrial fibrillation in the elderly (SAFE) trial. BMJ. 2007 Aug 25;335(7616):380. doi: 10.1136/bmj.39227.551713.AE. Epub 2007 Jun 29.
Hobbs FD, Fitzmaurice DA, Mant J, Murray E, Jowett S, Bryan S, Raftery J, Davies M, Lip G. A randomised controlled trial and cost-effectiveness study of systematic screening (targeted and total population screening) versus routine practice for the detection of atrial fibrillation in people aged 65 and over. The SAFE study. Health Technol Assess. 2005 Oct;9(40):iii-iv, ix-x, 1-74. doi: 10.3310/hta9400.
Sudlow M, Rodgers H, Kenny RA, Thomson R. Identification of patients with atrial fibrillation in general practice. BMJ. 1999 Jan 23;318(7178):264. doi: 10.1136/bmj.318.7178.264. No abstract available.
Bjorck S, Palaszewski B, Friberg L, Bergfeldt L. Atrial fibrillation, stroke risk, and warfarin therapy revisited: a population-based study. Stroke. 2013 Nov;44(11):3103-8. doi: 10.1161/STROKEAHA.113.002329. Epub 2013 Aug 27.
Lee VW, Tam CS, Yan BP, Man Yu C, Yin Lam Y. Barriers to warfarin use for stroke prevention in patients with atrial fibrillation in Hong Kong. Clin Cardiol. 2013 Mar;36(3):166-71. doi: 10.1002/clc.22077. Epub 2012 Nov 14.
Koponen L, Rekola L, Ruotsalainen T, Lehto M, Leino-Kilpi H, Voipio-Pulkki LM. Patient knowledge of atrial fibrillation: 3-month follow-up after an emergency room visit. J Adv Nurs. 2008 Jan;61(1):51-61. doi: 10.1111/j.1365-2648.2007.04465.x.
Smith MB, Christensen N, Wang S, Strohecker J, Day JD, Weiss JP, Crandall BG, Osborn JS, Anderson JL, Horne BD, Muhlestein JB, Lappe DL, Moss H, Oliver J, Viau K, Bunch TJ. Warfarin knowledge in patients with atrial fibrillation: implications for safety, efficacy, and education strategies. Cardiology. 2010;116(1):61-9. doi: 10.1159/000314936. Epub 2010 May 26.
Court H, Greenland K, Margrain TH. Measuring patient anxiety in primary care: Rasch analysis of the 6-item Spielberger State Anxiety Scale. Value Health. 2010 Sep-Oct;13(6):813-9. doi: 10.1111/j.1524-4733.2010.00758.x. Epub 2010 Jun 17.
Marjoram J, Strachan R, Allan A, Allan E. Screening for colorectal cancer: a general-practice-based study. Br J Gen Pract. 1996 May;46(406):283-86.
Other Identifiers
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HK-OPD-AF
Identifier Type: -
Identifier Source: org_study_id