Clinical trial NCT06458829: Promoting Atrial Fibrillation Screening in Primary Care
Official title: Effects of an Implementation Program to Promote Atrial Fibrillation Screening in Primary Care Centers in China
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation New Onset
Keywords: Atrial Fibrillation
Disease screening
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 4800
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: SCREENING

Brief 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.

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 ).

Eligibility criteria: 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

Primary outcomes:
measure: Atrial fibrillation detection rate
timeFrame: End of the intervention (T0), three-month (T1) and six-month (T2) after the intervention.
Secondary outcomes:
measure: Anticoagulation rate
timeFrame: Three-month and six-month post the intervention
measure: Cost-effectiveness
timeFrame: Six-month post the intervention
measure: Atrial fibrillation associated events
timeFrame: Three-month and six-month post the intervention
measure: Atrial fibrillation related medical resource consumption
timeFrame: Three-month and six-month post the intervention
measure: Compliance with atrial fibrillation screening
timeFrame: Three-month and six-month post the intervention
Other outcomes:
Locations:
Study officials:
affiliation: Sun Yat-sen University
name: Xi CAO
role: PRINCIPAL_INVESTIGATOR
References: