Viewing Study NCT06458829



Ignite Creation Date: 2024-06-16 @ 11:52 AM
Last Modification Date: 2024-10-26 @ 3:32 PM
Study NCT ID: NCT06458829
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-06-14
First Post: 2024-06-03

Brief Title: Promoting Atrial Fibrillation Screening in Primary Care
Sponsor: Sun Yat-sen University
Organization: Sun Yat-sen University

Study Overview

Official Title: Effects of an Implementation Program to Promote Atrial Fibrillation Screening in Primary Care Centers in China
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None