Atrial Fibrillation, Heart Failure
Conditions
Brief summary
This cluster randomized study aims to compare village doctor-led integrated care versus usual care to improve cardiovascular health, atrial fibrillation management, self-management adherence, and heart failure prevention among older rural patients with atrial fibrillation in China.
Detailed description
BACKGROUND Atrial fibrillation (AF) is common among older adults and is strongly associated with heart failure (HF), stroke, hospitalization, cardiovascular death, and all-cause mortality. AF and HF interact bidirectionally and may form a self-perpetuating cycle, particularly in older patients. Although the Atrial Fibrillation Better Care (ABC) pathway is recommended to improve the comprehensive management of AF, older adults with AF in rural China remain particularly vulnerable because of limited access to specialist care, inadequate HF screening and risk stratification, suboptimal implementation of guideline-recommended treatment, and insufficient continuity of follow-up. HF is one of the most common and clinically important complications of AF and is strongly associated with adverse prognosis. Therefore, AF management should extend beyond stroke prevention and incorporate earlier identification, prevention, and management of HF. China's rural primary healthcare system relies heavily on village doctors; however, village doctors often have limited clinical resources, standardized training, and access to specialist support, which may hinder the delivery of long-term integrated care for patients with AF who are at risk of developing HF. A telemedicine-supported, village-doctor-led integrated care model incorporating regular follow-up, medication review, cardiovascular risk monitoring, ABC pathway-based AF management, simplified exercise rehabilitation, timely specialist consultation, and structured patient education may therefore improve cardiovascular health and reduce the risk of incident HF in this population. AIM OF THIS STUDY This cluster randomized study aims to compare village doctor-led integrated care versus usual care in improving cardiovascular health, guideline-based AF management, self-management adherence, clinical outcomes, and prevention of HF among older rural patients with AF in China. DESIGN This study is a prospective, cluster randomized, open-label, parallel-group clinical trial conducted in rural China. The study aims to enroll older rural residents aged 65 to 80 years with documented AF and without a history or screening evidence of HF or asymptomatic left ventricular dysfunction at baseline. Village clinics in Jiangsu Province will be randomized in a 1:1 ratio to either the intervention group or the control group. Patients in the intervention group will receive telemedicine-supported, village doctor-led integrated care, including monthly follow-up, symptom assessment, vital-sign monitoring, medication adherence support, cardiovascular risk-factor management, ABC pathway-based AF care, simplified home-based exercise rehabilitation education, and remote cardiology consultation when needed. Village doctors will receive standardized training on stroke prevention and anticoagulation, symptom and rate/rhythm management, and management of cardiovascular risk factors and comorbidities. Patients in the control group will receive usual chronic disease management according to the National Basic Public Health Service requirements, including routine follow-up, general health education, medication documentation, and referral when clinically indicated. Follow-up will last up to 48 months. The primary outcome at 12 months is the change in Life's Essential 8 cardiovascular health score from baseline. The primary outcome at 36 months is a composite cardiovascular endpoint including cardiovascular death, ischemic or hemorrhagic stroke, hospitalization for worsening HF or acute coronary syndrome, and emergency department visits due to AF. The primary outcome at 48 months is the incidence of asymptomatic left ventricular dysfunction with or without HF.
Interventions
1. Village doctors will conduct monthly follow-up, including symptom assessment, vital-sign monitoring, medication adherence support, cardiovascular risk-factor management, health education, and referral when needed. 2. Village doctors will provide AF management based on the ABC pathway and simplified home-based exercise rehabilitation education. 3. When clinical deterioration or management difficulties occur, village doctors may use a remote care platform to obtain cardiology specialist consultation and treatment recommendations within 24 hours. 4. Village doctors will receive standardized training on AF management, anticoagulation, rate/rhythm control, and cardiovascular risk-factor management. 5. Patients will receive structured education on medication adherence, symptom monitoring, lifestyle modification, exercise rehabilitation, and recognition of warning signs.
OTHERUsual Care
Participants in the control group will receive usual chronic disease management according to the National Basic Public Health Service requirements. Usual care includes routine follow-up, general health education, medication registration, and standard referral procedures provided by local primary care providers. Participants will not receive the structured village-doctor led integrated care program.
Sponsors
Jiangsu Taizhou People's Hospital
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 80 Years
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 aged 65-80 years. 2)Availability of an electrocardiogram confirming atrial fibrillation, or an official diagnosis certificate of atrial fibrillation issued by a specialist. 3)Receiving healthcare management from a primary medical institution near the place of residence. 4)Able to understand and sign the informed consent form.
Exclusion criteria
1. A definite history of heart failure, or confirmed cardiac dysfunction or heart failure based on echocardiography and/or NT-proBNP screening. Diagnostic criteria include typical heart failure symptoms or signs with reduced left ventricular ejection fraction (HFrEF, LVEF \<40%), mildly reduced left ventricular ejection fraction (HFmrEF, LVEF 40-49%), or preserved left ventricular ejection fraction with elevated NT-proBNP and structural heart disease evidence (HFpEF, LVEF ≥50%, with at least one of the following: LAVI \>40 mL/m², E/e' ≥15, or TRV \>2.8 m/s). 2. Expected survival of less than 12 months. 3. Severe renal insufficiency, defined as creatinine clearance \<30 mL/min, or currently receiving dialysis treatment. 4. Cardiac dysfunction caused by reversible secondary causes, including hyperthyroid heart disease, anemic heart disease, or uncorrected congenital heart disease. 5. Indication for pacemaker implantation but without pacemaker placement. 6. Chronic obstructive pulmonary disease complicated by type II respiratory failure. 7. Special populations, such as patients with mental illness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Life's Essential 8 Cardiovascular Health Score | Baseline to 12 months | Mean change in Life's Essential 8 cardiovascular health score from baseline to 12 months. The score includes diet, physical activity, nicotine exposure, sleep health, body mass index, non-HDL cholesterol, blood glucose, and blood pressure. |
| Composite Cardiovascular Outcome | Baseline to 36 months | Composite cardiovascular endpoint, including cardiovascular death, ischemic or hemorrhagic stroke, hospitalization for worsening heart failure or acute coronary syndrome, and emergency visits due to atrial fibrillation. |
| Incidence of Asymptomatic Left Ventricular Dysfunction With or Without Heart Failure | Baseline to 48 months | Incidence of asymptomatic left ventricular dysfunction with or without heart failure, assessed by clinical evaluation, NT-proBNP, and echocardiographic evidence of cardiac dysfunction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular Death | 12 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 |
| Cardiovascular Hospitalization | 12 months after baseline | Hospitalization due to cardiovascular or neurological diseases at township-level or higher hospitals, including heart failure, cardiac arrhythmia, acute coronary syndrome, hypertensive emergency or urgency, ischemic or hemorrhagic stroke, and transient ischemic attack. |
| Emergency Visit for Cardiovascular Events | 12 months after baseline | Incidence of emergency visits for cardiovascular events, including exacerbation of heart failure or acute coronary syndrome. |
| ischemic or hemorrhagic Stroke | 12 months after baseline | All strokes: ischemic or hemorrhagic Stroke |
| The proportion of patients who met all the three criteria for the ABC pathway of integrated AF care | 12 month 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' |
| Ischemic or hemorrhagic Stroke | 36 months after baseline | All strokes: ischemic or hemorrhagic Stroke |
| 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 |
| Emergency visit due to AF | 36 months after baseline | Emergency visit due to AF |
| All-cause mortality | 36 months after baseline | all-cause death |
| The proportion of patients who met all the three criteria for the ABC pathway | 36 month 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' |
Countries
China
Contacts
CONTACTMing Chu
Outcome results
None listed