Atrial FibrillationNCT02409654
Hong Kong Outpatient AF Screening Using Single-lead ECG Device
A study testing Patient education and Routine care in people with Atrial Fibrillation, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Patient education and Routine care
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2015to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged 65 years or over
Who cannot join
- Severe coexisting medical condition that would prevent participation (eg, dementia, terminal illness)
- Inability to read/understand the consent form and participation information statement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Tailored Stroke Prevention Strategy for Newly Diagnosed Atrial Fibrillation From a Targeted Screening Program Using Handheld Single-lead ECG Device
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.
Read the detailed description
Study Design
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
- Atrial Fibrillation
- Being tested
- Patient education, Routine care
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Patient education; Other: 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. Receives: Other: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Utilization rates of evidence-based stroke prevention therapy
Measured: 3 years
Secondary outcomes (4)
Rates of newly diagnosed atrial fibrillation in elderly >65 years of age
Measured: 3 years
Clinical outcomes including death, stroke and bleeding
Measured: 12 months
Patient awareness questionnaire
Measured: 12 months
Incremental cost per new AF case detected
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study start1 Jan 2015
- Primary completion31 Dec 2017
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sydney
- Responsible party
- Principal investigator, Professor Bryan Ping Yen YAN, Chinese University of Hong Kong
- Investigators
- Bryan P Yan, MBBS, FACC, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409654
- Sponsor's protocol ID
- HK-OPD-AF
- Status last verified
- Oct 2021
- First submitted
- 30 Mar 2015
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22922413Mant 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.
PubMed 17604299Hobbs 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.
PubMed 16202350Sudlow 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.
PubMed 9915750Bjorck 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.
PubMed 23982711Lee 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.
PubMed 23151816Koponen 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.
PubMed 18173735Smith 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.
PubMed 20502012Court 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.
PubMed 20561315Marjoram 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.
PubMed 8762743
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Tailored Stroke Prevention Strategy for Newly Diagnosed Atrial Fibrillation From a Targeted Screening Program Using Handheld Single-lead ECG Device
- ClinicalTrials.gov ID
- NCT02409654
- Acronym / sponsor ID
- HK-OPD-AF
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- University of Sydney
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 7 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Design
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized stroke prevention | Active comparator | Other: Patient education, Other: Routine care(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 | Placebo comparator | Other: Routine careThe iECG tracing and report is provided to the attending doctor. Prescription of OAC is left to the discretion of the attending doctor. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Aged 65 years or over
Key exclusion criteria (2 listed)
- Severe coexisting medical condition that would prevent participation (eg, dementia, terminal illness)
- Inability to read/understand the consent form and participation information statement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Individualized stroke prevention |
| Routine careThe iECG tracing and report is provided to the attending doctor. Prescription of OAC is left to the discretion of the attending doctor. | Other | Individualized stroke prevention, Routine Care |
Primary outcome
Utilization rates of evidence-based stroke prevention therapy
Time frame: 3 years
4 secondary outcomes
Rates of newly diagnosed atrial fibrillation in elderly >65 years of age
Time frame: 3 years
Clinical outcomes including death, stroke and bleeding
Time frame: 12 months
Patient awareness questionnaire
Time frame: 12 months
Incremental cost per new AF case detected
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Background: PubMed 22922413Camm 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.
- Background: PubMed 17604299Mant 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.
- Background: PubMed 16202350Hobbs 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.
- Background: PubMed 9915750Sudlow 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.
- Background: PubMed 23982711Bjorck 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.
- Background: PubMed 23151816Lee 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.
- Background: PubMed 18173735Koponen 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.
- Background: PubMed 20502012Smith 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.
- Background: PubMed 20561315Court 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.
- Background: PubMed 8762743Marjoram 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bryan P Yan, MBBS, FACC principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient education and Routine care in people with Atrial Fibrillation, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Utilization rates of evidence-based stroke prevention therapy (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02409654, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021.