A New Model of Integrated Care of Older Patients With Atrial Fibrillation in Rural China: a Cluster Randomization Trial (the MIRACLE-AF Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,039
- 试验地点
- 1
- 主要终点
- Primary Outcome of Stage 2: The composite of cardiovascular death, all stroke, worsening of heart failure or acute coronary syndrome, and emergency visits due to AF
研究概览
简要总结
This cluster randomization study aims to compare the village-doctor led telemedicine integrated care versus usual care to improve compliance with the Atrial Fibrillation Better Care (ABC) pathway components and outcomes for older patients with atrial fibrillation in rural China.
详细描述
BACKGROUND Atrial fibrillation（AF) prevalence increases sharply with age, and the risk of stroke, dementia, heart failure and death increases significantly. Integrated care for atrial fibrillation patients using simple ABC pathway ('A' Avoid stroke; 'B' Better symptom management; 'C' Cardiovascular and Comorbidity optimization) is associated with a lower risk of adverse outcomes included all-cause death, composite outcome of stroke/major bleeding/cardiovascular death, and first hospitalization. In China, the prevalence of AF is high, but older people living in rural areas are more vulnerable due to low awareness and treatment gaps caused by various factors. China's rural healthcare system, which is primarily reliant on village doctors, falls short of providing optimal management for AF. To support village doctors in providing integrated care for AF, we have developed a digital health support platform. However, the role of this novel telemedicine-based integrated care for AF patients in rural China remains unclear.
AIM OF THIS STUDY This cluster randomization study aims to compare the village-doctor led telemedicine integrated care versus usual care to improve outcome of older patients with atrial fibrillation in rural China.
DESIGN The MIRACLE-AF China trial is a perspective, cluster randomization clinical trial performed in rural China. We aim to include a minimum of 1000 patients with AF aged 65 years or above from around more than 30 village clinics. Follow-up duration of this study is up to 3 years and all patients are followed up every 3 months by rural doctors. Village clinics will be randomized to either the intervention group (the village-doctor led telemedicine integrated care) or the control group (enhanced usual care).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessment committee members will be blinded to the group assignment.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The village clinics need to be willing and able to provide integrated care to their patients with atrial fibrillation;
- •The village doctors from one village clinic serves all AF patients from 3-5 nearby villages;
- •The village doctors are trained to have a fundamental understanding of telemedicine;
- •Patients are eligible for participation if 1) they are aged 65 years or above; 2) they are diagnosed atrial fibrillation by an ECG, AF specialist, or hospital discharge letter; 3) they agree to receive the medical care provided by village clinics; 4) they provide written informed consent.
排除标准
- •Moderate to severe rheumatic mitral stenosis or heart valve replacement history.
- •Presence of ICD or CRT device.
- •Cardiac ablation or surgery <3 months prior to inclusion or being planned.
- •Pulmonary vein isolation or left atrial appendage occlusion history or plan to perform any of the above operations.
- •The life expectancy is less than 1 year.
- •Participation in other clinical trials.
结局指标
主要结局
Primary Outcome of Stage 2: The composite of cardiovascular death, all stroke, worsening of heart failure or acute coronary syndrome, and emergency visits due to AF
时间窗: 36 months after baseline
Cardiovascular death was defined as death attributable to myocardial infarction, heart failure, arrhythmia, cardiac perforation or tamponade, or other deaths of cardiac origin. Death caused by ischemic stroke, hemorrhagic stroke, peripheral embolism, and pulmonary embolism was also classified as cardiovascular death. All strokes included ischemic stroke and hemorrhagic stroke. A worsening of heart failure or acute coronary syndrome was defined as the need to be hospitalized or have an emergency visit in conjunction with these conditions
Primary Outcome of Stage 1: The proportion of patients who met all the three criteria for the ABC pathway of integrated AF care
时间窗: 12 months after baseline
The 'A' criterion referred to stroke prevention or anticoagulation. 'A criterion compliant' implies that either appropriate non-vitamin K antagonist oral anticoagulant (NOACs) use, or warfarin was used with a time in the therapeutic range (TTR) \>65%. Patients who were not properly treated with OACs are considered as 'A non-compliant'. The 'B' criterion referred to better symptom control with patient-centered decisions on rate or rhythm control. Patients with an EHRA score of I or II are considered to have good control of AF symptoms ('B compliant'). On the contrary, those with an EHRA score of III or IV were defined as 'B non-compliant', which means their symptoms were insufficiently controlled. The 'C' criterion stands for optimal management of cardiovascular risk factors and other comorbidities. 'C criterion compliant' implies that all the considered risk factors and comorbidities were well controlled or optimally treated. Otherwise, patients were considered as 'C non-compliant'
次要结局
- Secondary Outcome of Stage 1: The proportions of patients who meet the criterion for the A component in the ABC pathway(12 months after baseline)
- Secondary Outcome of Stage 2: Emergency visit due to AF(36 months after baseline)
- Secondary Outcome of Stage 2: The proportion of patients who met all the three criteria for the ABC pathway of integrated AF care(36 months after baseline)
- Secondary Outcome of Stage 2: Ischemic or hemorrhagic Stroke(36 months after baseline)
- Secondary Outcome of Stage 2: Major bleeding(36 months after baseline)
- Secondary Outcome of Stage 1: The proportions of patients who meet the criterion for the C component in the ABC pathway(12 months after baseline)
- Secondary Outcome of Stage 2: All-cause mortality(36 months after baseline)
- Secondary Outcome of Stage 1: The proportions of patients who meet the criterion for the B component in the ABC pathway(12 months after baseline)
- Secondary Outcome of Stage 2: Clinically relevant non-major bleeding(36 months after baseline)
- Secondary Outcome of Stage 2: Cardiovascular death(36 months after baseline)
- Secondary Outcome of Stage 2: Worsening of heart failure or acute coronary syndrome(36 months after baseline)
研究者
Minglong Chen
Deputy Director of the Department of Cardiology
The First Affiliated Hospital with Nanjing Medical University