Promoting Atrial Fibrillation Screening in Primary Care

NCT ID: NCT06458829

Last Updated: 2024-06-14

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

4800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2026-12-30

Brief Summary

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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

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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

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Atrial Fibrillation New Onset

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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.
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Intervention group

The intervention group will receive SEARCH-AF intervention which includes opportunistic screening and screening promoting strategies.

Group Type EXPERIMENTAL

SEARCH-AF

Intervention Type BEHAVIORAL

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.

Control group

All the control groups will finally receive the SEARCH-AF intervention.

Group Type ACTIVE_COMPARATOR

SEARCH-AF

Intervention Type BEHAVIORAL

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.

Interventions

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SEARCH-AF

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* aged 65 years or above
* living in community

Exclusion Criteria

* with a previous confirmed diagnosis of atrial fibrillation
* with implanted ICD or pacemaker
* unable to provide consent
* involving in other atrial fibrillation screening program
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Xi Cao

associated professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xi CAO

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Central Contacts

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Xi CAO, PhD

Role: CONTACT

(86)02084333829

Other Identifiers

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Sunyatsenu

Identifier Type: -

Identifier Source: org_study_id

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