New Model of Integrated Care of Older Patients With Atrial Fibrillation in Rural China (MIRACLE-AF)

Nanjing Medical University

Status: Completed

Conditions: Older; Atrial Fibrillation; Stroke

Treatments: Other: Enhanced usual care; Other: Village doctor-led telemedicine integrated care

Study type: Interventional

Funder types: Other

Identifiers

NCT04622514

2020-SR-027

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,039 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

1,039 participants in 2 patient groups

Village doctor-led telemedicine integrated care

Experimental group

Description:

To empower village doctors, a new technology-based model of AF care was established in the intervention group. A digital health support platform was developed by our research team, and a network of teams consisting of village doctors and AF specialists in our research team was established in the intervention group. With the aid of this telemedicine platform, village doctors can receive more support from AF specialists in providing integrated AF care to the rural elderly with AF.

Treatment:

Other: Village doctor-led telemedicine integrated care

Enhanced usual care

Active Comparator group

Description:

Usual care plus intensified education to patients, their family members, and their village doctors.

Treatment:

Other: Enhanced usual care