NCT02409654

Brief Summary

Stroke is a leading cause of mortality, morbidity and rising healthcare cost worldwide. In 'real-world' practice, AF is often diagnosed too late at time of stroke and detection can be difficult because AF may be present without symptoms and intermittent in nature. Furthermore, utilization of adequate oral anticoagulation therapy (OAC) for stroke prevention is suboptimal in Hong Kong. The challenge is to identify AF prior to occurrence of stroke. The latest European guidelines recommend opportunistic screening for people \>=65 years by pulse palpation followed by 12-lead ECG. However, 12-lead ECG requires a trained technician, time consuming, requires the patient to lie on an examination couch and is not readily available in most outpatient clinics in Hong Kong. A practical screening test is needed. Our study aims to evaluate the feasibility, acceptability and incremental cost of an outpatient based AFscreening program using the AliveCor device. Newly diagnosed AF patients will be randomized to routine care versus individualized stroke prevention strategy which consists of patient education, stroke and bleeding risk assessment, evidence-based OAC recommendation, patient audit and follow-up to improve OAC utilization for stroke prevention. We envisage this study will provide timely evidence to inform policy decisions concerning population-based AF-screening for AF for stroke prevention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable atrial-fibrillation

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 7, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

October 19, 2021

Status Verified

October 1, 2021

Enrollment Period

3 years

First QC Date

March 30, 2015

Last Update Submit

October 18, 2021

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Utilization rates of evidence-based stroke prevention therapy

    3 years

Secondary Outcomes (4)

  • Rates of newly diagnosed atrial fibrillation in elderly >65 years of age

    3 years

  • Clinical outcomes including death, stroke and bleeding

    12 months

  • Patient awareness questionnaire

    12 months

  • Incremental cost per new AF case detected

    3 years

Study Arms (2)

Individualized stroke prevention

ACTIVE COMPARATOR

(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

Other: Patient educationOther: Routine care

Routine Care

PLACEBO COMPARATOR

The iECG tracing and report is provided to the attending doctor. Prescription of OAC is left to the discretion of the attending doctor.

Other: Routine care

Interventions

Patient educationOTHER

(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

Individualized stroke prevention
Routine careOTHER

The iECG tracing and report is provided to the attending doctor. Prescription of OAC is left to the discretion of the attending doctor.

Individualized stroke preventionRoutine Care

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Aged 65 years or over

You may not qualify if:

  • Severe coexisting medical condition that would prevent participation (eg, dementia, terminal illness)
  • Inability to read/understand the consent form and participation information statement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

Location

Related Publications (10)

  • 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.

    PMID: 22922413BACKGROUND

  • 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.

    PMID: 17604299BACKGROUND

  • 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.

    PMID: 16202350BACKGROUND

  • 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.

    PMID: 9915750BACKGROUND

  • 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.

    PMID: 23982711BACKGROUND

  • 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.

    PMID: 23151816BACKGROUND

  • 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.

    PMID: 18173735BACKGROUND

  • 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.

    PMID: 20502012BACKGROUND

  • 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.

    PMID: 20561315BACKGROUND

  • 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.

    PMID: 8762743BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Bryan P Yan, MBBS, FACC

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 30, 2015

First Posted

April 7, 2015

Study Start

January 1, 2015

Primary Completion

December 31, 2017

Study Completion

September 30, 2019

Last Updated

October 19, 2021

Record last verified: 2021-10

Locations

HK(1)