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

  • STATUS
    Recruiting
  • End date
    Nov 30, 2023
  • participants needed
    1000
  • sponsor
    The First Affiliated Hospital with Nanjing Medical University
Updated on 26 January 2021

Summary

This cluster randomization study aims to compare the people-centered integrated care versus usual care to improve outcome of older patients with atrial fibrillation in rural China.

Description

BACKGROUND Atrial fibrillationAFprevalence increases sharply with age, and the risk of stroke, dementia, heart failure and death increases significantly. Epidemiological data show that the risk of atrial fibrillation-associated ischemic stroke in Asian population is higher than that in western population, but the use of oral anticoagulant is significantly lower than that in western population. However, elderly patients with atrial fibrillation often have a high risk of stroke and cerebral hemorrhage at the same time. How to balance the anticoagulant effect and bleeding risk is a challenge for rural doctors in rural China. 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. However, the role of people-centered integrated care for AF patients in rural China has remained unclear.

AIM OF THIS STUDY This cluster randomization study aims to compare the people-centered integrated care versus usual care to improve outcome of older patients with atrial fibrillation in rural China. The primary endpoint is the composite of cardiovascular death and all stroke. The secondary endpoints are All-cause mortality, cardiovascular death, cardiovascular hospitalization, ischemic or hemorrhagic stroke, major bleeding, clinically relevant nonmajor bleeding, quality of life.

DESIGN The MIRACLE-AF China trial is a multicenter, 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 (people-centered integrated care) or the control group (usual care).

Details
Condition Arrhythmia, Dysrhythmia, Arrhythmia, Atrial Fibrillation, Atrial Fibrillation, Atrial Fibrillation (Pediatric), Cerebrovascular accident, Stroke, Atrial Fibrillation (Pediatric), Stroke, Dysrhythmia, cerebrovascular accidents, strokes, cerebral, Older
Treatment Usual Care, People-centered integrated care
Clinical Study IdentifierNCT04622514
SponsorThe First Affiliated Hospital with Nanjing Medical University
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

The village clinics need to be willing and able to provide integrated care to their patients with atrial fibrillation; 2. The village doctor from one village clinic serves all AF patients from 2-3 nearby villages; 3. The village doctors are trained to adequately use the telemedicine system; 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 are receiving the medical care provided by village clinics; 4) they provide written informed consent
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Exclusion Criteria

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 3 months
Participation in other clinical trials related to atrial fibrillation
Unable to understand and sign the informed consent form. -
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