Promoting Atrial Fibrillation Screening in Primary Care

Sun Yat-sen University

Status: Not yet enrolling

Conditions: Atrial Fibrillation New Onset

Treatments: Behavioral: SEARCH-AF

Study type: Interventional

Funder types: Other

Identifiers

NCT06458829

Sunyatsenu

Details and patient eligibility

About

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.

Full 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 ).

Enrollment: 4,800 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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4,800 participants in 2 patient groups

Intervention group

Experimental group

Description:

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

Treatment:

Behavioral: SEARCH-AF

Control group

Active Comparator group

Description:

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

Treatment:

Behavioral: SEARCH-AF