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Not yet recruiting NCT06458829

Promoting Atrial Fibrillation Screening in Primary Care

No phase Interventional Atrial Fibrillation New Onset

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SEARCH-AF.
Who it may be relevant to
Registry conditions: Atrial Fibrillation New Onset. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effects of an Implementation Program to Promote Atrial Fibrillation Screening in Primary Care Centers in China

Overview

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 ).

Interventions

  • Behavioral 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

Primary outcome measures

  • Atrial fibrillation detection rate [Time frame: End of the intervention (T0), three-month (T1) and six-month (T2) after the intervention.]
Secondary outcome measures (5)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Screening

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06458829 · Sunyatsenu

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗