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

NCT04622514 | Completed DMC

• 1 other identifier: 2020-SR-027
• Study Type: interventional
• Target: 1,039
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Older; Stroke

Keywords

atrial fibrillation; integrated care; rural China; older; stroke

Outcome Measures

Primary Outcomes (2)

• Primary Outcome of Stage 1: The proportion of patients who met all the three criteria for the ABC pathway of integrated AF care

  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'

  12 months after baseline

• 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

  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

  36 months after baseline

Secondary Outcomes (11)

• 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 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 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 2: Cardiovascular death

  36 months after baseline

Study Arms (2)

Village doctor-led telemedicine integrated care

EXPERIMENTAL

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.

Other: Village doctor-led telemedicine integrated care

Enhanced usual care

ACTIVE COMPARATOR

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

Other: Enhanced usual care

Interventions

Village doctor-led telemedicine integrated care OTHER

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.

Village doctor-led telemedicine integrated care

Enhanced usual care OTHER

1\. Usual care; 2. Intensified education to patients, their family members, and their village doctors.

Enhanced usual care

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• Moderate to severe rheumatic mitral stenosis or heart valve replacement history.
• Presence of ICD or CRT device.
• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• University of Liverpool: collaborator

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 201129, China

Location

Related Publications (2)

• Chu M, Zhang S, Gong J, Yang S, Yang G, Sun X, Wu D, Xia Y, Jiao J, Peng X, Peng Z, Hong L, Wang Z, Li M, Lip GYH, Chen M; MIRACLE-AF Investigators. Telemedicine-based integrated management of atrial fibrillation in village clinics: a cluster randomized trial. Nat Med. 2025 Apr;31(4):1276-1285. doi: 10.1038/s41591-025-03511-2. Epub 2025 Feb 21.

  PMID: 39984634 DERIVED

• Li M, Chu M, Shen Y, Zhang S, Yin X, Yang S, Lip GYH, Chen M; MIRACLE-AF Trial Investigators. A Novel Model of Integrated Care of Older Patients With Atrial Fibrillation in Rural China. JACC Asia. 2024 Jul 30;4(10):764-773. doi: 10.1016/j.jacasi.2024.07.006. eCollection 2024 Oct.

  PMID: 39553909 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Minglong Chen, MD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessment committee members will be blinded to the group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of the Department of Cardiology

Study Record Dates

• First Submitted: October 18, 2020
• First Posted: November 10, 2020
• Study Start: December 1, 2020
• Primary Completion: May 9, 2024
• Study Completion: May 30, 2024
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)