NCT04622514

New Model of Integrated Care of Older Patients With Atrial Fibrillation in Rural China

A New Model of Integrated Care of Older Patients With Atrial Fibrillation in Rural China: a Cluster Randomization Trial (the MIRACLE-AF Trial)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,039 (actual)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Atrial Fibrillation
• Older
• Stroke

Interventions

Type	Name	Description
OTHER	Village doctor-led telemedicine integrated care	1\. Reorienting the model of care: using of telemedicine platform and online consulting clinic; 2. Coordinating services: contract service by village doctor and on-line AF specialist; 3. Empowering and engaging people: provide village doctor ABC pathway training course; regular visit and drug delivery by village doctor (community support); patients and their family members education.
OTHER	Enhanced usual care	1\. Usual care; 2. Intensified education to patients, their family members, and their village doctors.

Timeline

• Start date: 2020-12-01
• Primary completion: 2024-05-09
• Completion: 2024-05-30
• First posted: 2020-11-10
• Last updated: 2024-07-26

Locations

1 site across 1 country: China