Effects of an Implementation Program to Promote Atrial Fibrillation Screening in Primary Care Centers in China
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 4,800
- 主要终点
- Atrial fibrillation detection rate
研究概览
简要总结
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.
详细描述
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 ).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged 65 years or above
- •living in community
排除标准
- •with a previous confirmed diagnosis of atrial fibrillation
- •with implanted ICD or pacemaker
- •unable to provide consent
- •involving in other atrial fibrillation screening program
结局指标
主要结局
Atrial fibrillation detection rate
时间窗: End of the intervention (T0), three-month (T1) and six-month (T2) after the intervention.
Rate of newly detected atrial fibrillation. The data will be collected via medical records (primary care medical system) review and patient interview.
次要结局
- Anticoagulation rate(Three-month and six-month post the intervention)
- Cost-effectiveness(Six-month post the intervention)
- Atrial fibrillation related medical resource consumption(Three-month and six-month post the intervention)
- Compliance with atrial fibrillation screening(Three-month and six-month post the intervention)
- Atrial fibrillation associated events(Three-month and six-month post the intervention)
研究者
Xi Cao
associated professor
Sun Yat-sen University