Clinical trial NCT04622514: New Model of Integrated Care of Older Patients With Atrial Fibrillation in Rural China
Official title: A New Model of Integrated Care of Older Patients With Atrial Fibrillation in Rural China: a Cluster Randomization Trial (the MIRACLE-AF Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Older
Stroke
Keywords: atrial fibrillation
integrated care
rural China
older
stroke
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: University of Liverpool
First posted: 2020-11-10
Enrollment: 1039
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

1. The village clinics need to be willing and able to provide integrated care to their patients with atrial fibrillation; 2. The village doctors from one village clinic serves all AF patients from 3-5 nearby villages; 3. The village doctors are trained to have a fundamental understanding of telemedicine; 4. 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.

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Exclusion Criteria:

1. Moderate to severe rheumatic mitral stenosis or heart valve replacement history.
2. Presence of ICD or CRT device.
3. Cardiac ablation or surgery \<3 months prior to inclusion or being planned.
4. Pulmonary vein isolation or left atrial appendage occlusion history or plan to perform any of the above operations.
5. The life expectancy is less than 1 year.
6. Participation in other clinical trials.

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Primary outcomes:
measure: Primary Outcome of Stage 1: The proportion of patients who met all the three criteria for the ABC pathway of integrated AF care
timeFrame: 12 months after baseline
measure: 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
timeFrame: 36 months after baseline
Secondary outcomes:
measure: Secondary Outcome of Stage 1: The proportions of patients who meet the criterion for the A component in the ABC pathway
timeFrame: 12 months after baseline
measure: Secondary Outcome of Stage 1: The proportions of patients who meet the criterion for the B component in the ABC pathway
timeFrame: 12 months after baseline
measure: Secondary Outcome of Stage 1: The proportions of patients who meet the criterion for the C component in the ABC pathway
timeFrame: 12 months after baseline
measure: Secondary Outcome of Stage 2: All-cause mortality
timeFrame: 36 months after baseline
measure: Secondary Outcome of Stage 2: Cardiovascular death
timeFrame: 36 months after baseline
measure: Secondary Outcome of Stage 2: Ischemic or hemorrhagic Stroke
timeFrame: 36 months after baseline
measure: Secondary Outcome of Stage 2: Worsening of heart failure or acute coronary syndrome
timeFrame: 36 months after baseline
measure: Secondary Outcome of Stage 2: Emergency visit due to AF
timeFrame: 36 months after baseline
measure: Secondary Outcome of Stage 2: Major bleeding
timeFrame: 36 months after baseline
measure: Secondary Outcome of Stage 2: Clinically relevant non-major bleeding
timeFrame: 36 months after baseline
measure: Secondary Outcome of Stage 2: The proportion of patients who met all the three criteria for the ABC pathway of integrated AF care
timeFrame: 36 months after baseline
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Minglong Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: