Atrial Fibrillation, Older, Stroke
Conditions
Keywords
atrial fibrillation, integrated care, rural China, older, stroke
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.
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).
Interventions
OTHERVillage 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.
OTHEREnhanced usual care
1\. Usual care; 2. Intensified education to patients, their family members, and their village doctors.
Sponsors
University of Liverpool
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessment committee members will be blinded to the group assignment.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
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 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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome of Stage 1: The proportion of patients who met all the three criteria for the ABC pathway of integrated AF care | 12 months after baseline | 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' |
| 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 | 36 months after baseline | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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' |
| Secondary Outcome of Stage 2: All-cause mortality | 36 months after baseline | all-cause death |
| Secondary Outcome of Stage 2: Cardiovascular death | 36 months after baseline | 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 |
| Secondary Outcome of Stage 2: Ischemic or hemorrhagic Stroke | 36 months after baseline | All strokes: ischemic or hemorrhagic Stroke |
| 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 | The 'A' criterion referred to stroke prevention or anticoagulation. Thus, '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' |
| Secondary Outcome of Stage 2: Emergency visit due to AF | 36 months after baseline | Emergency visit due to AF |
| Secondary Outcome of Stage 2: Major bleeding | 36 months after baseline | Major bleeding was defined as fatal bleeding, bleeding in a critical area or organ, or clinically overt bleeding leading to a decrease in the hemoglobin level ≥2 g/dl or transfusion of ≥2 units of packed red cells |
| Secondary Outcome of Stage 2: Clinically relevant non-major bleeding | 36 months after baseline | Clinically relevant non-major bleeding referred to bleeding that does not meet the criteria for the ISTH definition of major bleeding but is clinically overt bleeding associated with hospital admission, physician-guided medical or surgical treatment, or a change in antithrombotic therapy. |
| Secondary Outcome of Stage 2: The proportion of patients who met all the three criteria for the ABC pathway of integrated AF care | 36 months after baseline | 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' |
| Secondary Outcome of Stage 2: Worsening of heart failure or acute coronary syndrome | 36 months after baseline | 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 |
| 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 | The 'B' criterion referred to better symptom control with patient-centered decisions on rate or rhythm control. Patients with an European Heart Rhythm Association (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 |
Countries
China
Outcome results
None listed