Atrial Fibrillation New OnsetNCT06458829
Promoting Atrial Fibrillation Screening in Primary Care
A study testing SEARCH-AF in people with Atrial Fibrillation New Onset, run by Sun Yat-sen University.
Trial summary
Atrial fibrillation is the most common sustained cardiac arrhythmia in adults. Due to the asymptomatic and paroxysmal nature (randomly and shortly occurring of atrial fibrillation, and can therefore remain unnoticed) of atrial fibrillation. Atrial fibrillation increases the risk of stroke five fold if left untreated. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation New Onset
- What is being tested?
- SEARCH-AF
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,800 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- aged 65 years or above
- living in community
Who cannot join
- with a previous confirmed diagnosis of atrial fibrillation
- with implanted ICD or pacemaker
- unable to provide consent
- involving in other atrial fibrillation screening program
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of an Implementation Program to Promote Atrial Fibrillation Screening in Primary Care Centers in China
Atrial fibrillation is the most common sustained cardiac arrhythmia in adults. Due to the asymptomatic and paroxysmal nature (randomly and shortly occurring of atrial fibrillation, and can therefore remain unnoticed) of atrial fibrillation. Atrial fibrillation increases the risk of stroke five fold if left untreated.
Screening in old populations above age 65 years is helpful to find more atrial fibrillation cases. However, screening for atrial fibrillation is not well implemented in China. Thus, this project aims to promote atrial fibrillation screening in primary care centers in China. We will develop an intervention program (SEARCH-AF) and examine the effects (including the clinical effects and implementation effects) of program.
Read the detailed description
Six health care centers in Guangzhou China will be included. We will adopt a stepped-wedge randomized trial design. Two health care centers will be randomly selected to receive the SEARCH-AF program at each step (a total of three steps).
The SEARCH-AF program will include opportunistic screening among those who aged 65 or above and screening promoting strategies. The A total of 4800 old adults will be screened for atrial fibrillation using a handheld single-lead ECG tool upon their visit to family doctor, with 800 for each health care center. The promoting strategy will be developed based on the Consolidated Framework for Implementation Research and include leadership engagement, policy support, providing screening resources, staff training on atrial fibrillation screening and management.
The whole study will last for 18 months. We will examine the intervention effects including clinical effects (atrial fibrillation detection rate, anticoagulation rate, atrial fibrillation related hospital visits, and stroke related end points) and implementation effects (cost-effectiveness of the intervention, compliance to atrial fibrillation screening ).
- Conditions
- Atrial Fibrillation New Onset
- Being tested
- SEARCH-AF
- Keywords
- Atrial Fibrillation, Disease screening
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEARCH-AFBehavioural
SEARCH-AF program will include opportunistic screening among old adults during primary care visits and promoting strategies. Promoting strategies will be developed based on the Consolidated Framework for Implementation Research framework which may include leadership engagement, policy support, providing screening resources, atrial fibrillation screening and management training. General practitioner or nurse in each health care center will implement point-on-care screening. The intervention will last for six months and followed up for another six months.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group will receive SEARCH-AF intervention which includes opportunistic screening and screening promoting strategies. Receives: Behavioral: SEARCH-AF |
| Control group | Active comparator | All the control groups will finally receive the SEARCH-AF intervention. Receives: Behavioral: SEARCH-AF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrillation detection rate
Rate of newly detected atrial fibrillation. The data will be collected via medical records (primary care medical system) review and patient interview.
Measured: End of the intervention (T0), three-month (T1) and six-month (T2) after the intervention.
Secondary outcomes (5)
Anticoagulation rate
Anticoagulation rate among the newly detected atrial fibrillation cases. The data will be collected via medical records (primary care medical system) review and patient interview.
Measured: Three-month and six-month post the intervention
Cost-effectiveness
Cost-effectiveness refers to the cost of screening for one atrial fibrillation and preventing for one stroke, respectively. It will be assessed using cost-effectiveness ratio. The cost of intervention will include the direct screening cost (screening tool, manpower for carrying out the screening, training on screening, leaflet etc), cost on anticoagulation (expense on oral anticoagulants) and stroke treatment (in-hospital and out-of-hospital cost on stroke treatment). The cost of control group will include the cost on anticoagulation(expense on oral anticoagulants) and stroke treatment (in-hospital and out-of-hospital cost on stroke treatment ). All the cost data will be collected using a patient-reported information sheet.
Measured: Six-month post the intervention
Atrial fibrillation associated events
Including stroke, bleeding events associated with anticoagulation (referred to bleeding that requires in-hospital treatment), and death. The data will be collected via medical records (primary care medical system) and patient interview.
Measured: Three-month and six-month post the intervention
Atrial fibrillation related medical resource consumption
Including the number of in-hospital and out-of-hospital visits due to atrial fibrillation. Such data will be collected using a patient-reported information sheet.
Measured: Three-month and six-month post the intervention
Compliance with atrial fibrillation screening
Compliance with atrial fibrillation screening refers to the degree of general practitioner/nurse perform screening as requested during the follow-up. It will be calculated by the number of practitioners/nurses who remained in the screening during follow-up/ the initial number of practitioner/nurse performing the screening. Such data will be collected using a practitioner/nurse-reported information sheet.
Measured: Three-month and six-month post the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation New OnsetStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Sequential
- Model description
- Stepped-Wedge Cluster Randomized Trial. Six community centers will be included. There will be three steps for intervention implementation. Tat each step, two centers will be randomly assigned to receive intervention, other centers will serve as control group or maintain post-intervention status.
- Masking
- None (open label)
- Enrolment
- 4,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xi Cao, Sun Yat-sen University
- Investigators
- Xi CAO, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458829
- Sponsor's protocol ID
- Sunyatsenu
- Status last verified
- Jun 2024
- First submitted
- 3 Jun 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Implementation Program to Promote Atrial Fibrillation Screening in Primary Care Centers in China
- ClinicalTrials.gov ID
- NCT06458829
- Acronym / sponsor ID
- Sunyatsenu
- Conditions
- Atrial Fibrillation New Onset
- Keywords
- Atrial Fibrillation, Disease screening
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,800 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 14 Jun 2024 (actual)
- 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.
Atrial fibrillation is the most common sustained cardiac arrhythmia in adults. Due to the asymptomatic and paroxysmal nature (randomly and shortly occurring of atrial fibrillation, and can therefore remain unnoticed) of atrial fibrillation. Atrial fibrillation increases the risk of stroke five fold if left untreated.
Screening in old populations above age 65 years is helpful to find more atrial fibrillation cases. However, screening for atrial fibrillation is not well implemented in China. Thus, this project aims to promote atrial fibrillation screening in primary care centers in China. We will develop an intervention program (SEARCH-AF) and examine the effects (including the clinical effects and implementation effects) of program.
Detailed description
Six health care centers in Guangzhou China will be included. We will adopt a stepped-wedge randomized trial design. Two health care centers will be randomly selected to receive the SEARCH-AF program at each step (a total of three steps).
The SEARCH-AF program will include opportunistic screening among those who aged 65 or above and screening promoting strategies. The A total of 4800 old adults will be screened for atrial fibrillation using a handheld single-lead ECG tool upon their visit to family doctor, with 800 for each health care center. The promoting strategy will be developed based on the Consolidated Framework for Implementation Research and include leadership engagement, policy support, providing screening resources, staff training on atrial fibrillation screening and management.
The whole study will last for 18 months. We will examine the intervention effects including clinical effects (atrial fibrillation detection rate, anticoagulation rate, atrial fibrillation related hospital visits, and stroke related end points) and implementation effects (cost-effectiveness of the intervention, compliance to atrial fibrillation screening ).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped-Wedge Cluster Randomized Trial. Six community centers will be included. There will be three steps for intervention implementation. Tat each step, two centers will be randomly assigned to receive intervention, other centers will serve as control group or maintain post-intervention status.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: SEARCH-AFThe intervention group will receive SEARCH-AF intervention which includes opportunistic screening and screening promoting strategies. |
| Control group | Active comparator | Behavioral: SEARCH-AFAll the control groups will finally receive the SEARCH-AF intervention. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- aged 65 years or above
- living in community
Key exclusion criteria (4 listed)
- with a previous confirmed diagnosis of atrial fibrillation
- with implanted ICD or pacemaker
- unable to provide consent
- involving in other atrial fibrillation screening program
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 |
|---|---|---|
| SEARCH-AFSEARCH-AF program will include opportunistic screening among old adults during primary care visits and promoting strategies. Promoting strategies will be developed based on the Consolidated Framework for Implementation Research framework which may include leadership engagement, policy support, providing screening resources, atrial fibrillation screening and management training. General practitioner or nurse in each health care center will implement point-on-care screening. The intervention will last for six months and followed up for another six months. | Behavioural | Control group, Intervention group |
Primary outcome
Atrial fibrillation detection rate
Time frame: End of the intervention (T0), three-month (T1) and six-month (T2) after the intervention.
Rate of newly detected atrial fibrillation. The data will be collected via medical records (primary care medical system) review and patient interview.
5 secondary outcomes
Anticoagulation rate
Time frame: Three-month and six-month post the intervention
Cost-effectiveness
Time frame: Six-month post the intervention
Atrial fibrillation associated events
Time frame: Three-month and six-month post the intervention
Atrial fibrillation related medical resource consumption
Time frame: Three-month and six-month post the intervention
Compliance with atrial fibrillation screening
Time frame: Three-month and six-month post the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Xi CAO principal investigator
Sun Yat-sen University
Questions about this trial
What is this clinical trial studying?
A study testing SEARCH-AF in people with Atrial Fibrillation New Onset, run by Sun Yat-sen University.
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 2 inclusion and 4 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: opening soon, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xi CAO, PhD ((86)02084333829, caox29@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial fibrillation detection rate (time frame: End of the intervention (T0), three-month (T1) and six-month (T2) after the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jun 2024.