New Model of Integrated Care of Older Patients With Atrial Fibrillation in Rural China
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| ClinicalTrials.gov Identifier: NCT04622514 |
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Recruitment Status :
Recruiting
First Posted : November 10, 2020
Last Update Posted : November 10, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Atrial Fibrillation Older Stroke | Other: People-centered integrated care Other: Usual care | Not Applicable |
BACKGROUND Atrial fibrillation（AF）prevalence 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).
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 1000 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A New Model of Integrated Care of Older Patients With Atrial Fibrillation in Rural China: a Cluster Randomization Trial (MIRACLE-AF China Trial) |
| Estimated Study Start Date : | November 10, 2020 |
| Estimated Primary Completion Date : | November 30, 2023 |
| Estimated Study Completion Date : | November 30, 2023 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: people-centered integrated care |
Other: People-centered 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. |
| Active Comparator: usual care |
Other: Usual care
Routine outpatient clinic by AF specialist |
- The composite of cardiovascular death and all stroke [ Time Frame: Follow-up duration of this study is up to 3 years ]all stroke include Ischemic or hemorrhagic Stroke and TIA
- All-cause mortality [ Time Frame: Follow-up duration of this study is up to 3 years ]
- Cardiovascular death [ Time Frame: Follow-up duration of this study is up to 3 years ]
- Cardiovascular hospitalization [ Time Frame: Follow-up duration of this study is up to 3 years ]
- Ischemic or hemorrhagic Stroke [ Time Frame: Follow-up duration of this study is up to 3 years ]
- Major bleeding [ Time Frame: fFollow-up duration of this study is up to 3 years ]
- Clinically relevant nonmajor bleeding [ Time Frame: Follow-up duration of this study is up to 3 years ]
- Quality of life measure by EQ-5 [ Time Frame: Follow-up duration of this study is up to 3 years ]measure quality of life by EQ-5
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| Ages Eligible for Study: | 65 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 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. -
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04622514
| Contact: ming chu, PHD | 86-2568136965 | chuming@njmu.edu.cn |
| China, Jiangsu | |
| The First Affiliated Hospital of Nanjing Medical University | Recruiting |
| Nanjing, Jiangsu, China, 201129 | |
| Contact: Ming Chu, PhD 13814010410 chuming@njmu.edu.cn | |
| Contact: Zidun Wang, PhD 13770837363 wangzidun@qq.com | |
| Principal Investigator: Minglong Chen, MD | |
| Responsible Party: | Minglong Chen, Deputy Director of the Department of Cardiology, The First Affiliated Hospital with Nanjing Medical University |
| ClinicalTrials.gov Identifier: | NCT04622514 |
| Other Study ID Numbers: |
2020-SR-027 |
| First Posted: | November 10, 2020 Key Record Dates |
| Last Update Posted: | November 10, 2020 |
| Last Verified: | November 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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atrial fibrillation integrated care rural China older stroke |
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Atrial Fibrillation Cardiovascular Diseases Arrhythmias, Cardiac Heart Diseases Pathologic Processes |