Cardiovascular diseases Circulatory System Cardiovascular disease, unspecified
Conditions
Interventions
Interventions as of 29/07/2016:
1. Prescribing a combination of drugs: anti-hypertensives, low dose aspirin and a statin
2. Adherence support on drug compliance, attendance at appointments and healthy lifestyle change
3. Health education: advice on smoking cessation, reduction of salt, sugar and oil in their diet, and physical exercise.
Previous interventions as of 06/12/2012:
1. Pr
Sponsors
University of Leeds
Zhejiang Provincial Center for Disease Control
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria as of 29/07/2016: Township hospitals: 1. Have family doctors who provide care according to the essential public health tasks requested by the government and who agree to follow the allocated treatment 2. Are willing to participate in the trial or pilot study High CVD risk subjects: 1. Adults aged 50-74 years who have provided informed consent 2. Have been diagnosed as hypertension with a calculated 10-year CVD risk of 20% or higher, or have a recorded medical history of diabetes 3. Hold permanent residency in the study area Previous inclusion criteria as of 06/12/2012: Township hospitals: 1. Have family doctors who provide care according to the essential public health tasks requested by the government and who agree to follow the allocated treatment 2. Are willing to participate in the trial or pilot study High CVD risk subjects: 1. Adults aged 60 years and above who have provided informed consent 2. Hold permanent residency in the study area 3. Have a calculated 10-year CVD risk of 20% or higher 4. Have a recorded medical history of diabetes, hyperlipidaemia, coronary heart disease, ischaemic or haemorrhagic cerebro-vascular disease, or peripheral vascular disease. Previous inclusion criteria until 06/12/2012: Township hospitals: 1. Located in rural Zhejiang 2. Have family doctors who provide care according to the essential public health tasks requested by the government and who agree to follow the allocated treatment 3. Are willing to participate in the trial or pilot study High CVD risk subjects: 1. Adults aged 40-74 years who have provided informed consent 2. Hold permanent residency in the study area 3. Have a calculated 10-year CVD risk of 20% or higher, including those having a recorded medical history of hypertension (>140/90) 4. Diabetes, hyperlipidaemia, coronary heart disease, ischaemic or haemorrhagiccerebro-vascular disease, or peripheral vascular disease, or those without CVD symptoms.
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 06/12/2012: 1. People with known mental illnesses or other severe diseases or disabilities which mean they cannot communicate with township doctors well or regularly 2. Those not living in the community or will move away in the next two years 3. People who have shown serious adverse effects to the recommended drugs 4. Patients who decline to participate in the trial will be excluded Previous exclusion criteria until 06/12/2012: 1. People with known mental illnesses or other severe diseases or disabilities which mean they cannot communicate with township doctors well or regularly 2. Those not living in the community or will move away in the next three years after recruitment 3. People who have shown serious adverse effects to the recommended drugs 4. Pregnant or breastfeeding women 5. Patients who decline to participate in the trial will be excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 06/12/2012: The major CVD event rates of the residents in study areas Previous primary outcome measure until 06/12/2012: The percentage of end events in CVD morbidity and mortality | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 29/07/2016: 1. Mean systolic and diastolic blood pressures of participants 2. Time to the first reported CVD event, mortality, and morbidity of CVD events during the trial period of 36 months 3. Mean change in glycated hemoglobin (HbA1c) 4. Mean change in serum TC and low density lipoprotein 5. Adherence to booked appointments, using the denominator of all participants registered, including defaulters 6. Self-reported adherence to drugs and healthy lifestyle change, for example, smoking cessation rates (for participants who smoke at randomization, the percentage who smoke less than one cigarette a week at 24 months after randomization) 7. Cost-effectiveness 8. Feasibility measures Previous secondary outcome measures until 06/12/2012: 1. Mean systolic and diastolic blood pressure 2. CVD risk scores 3. Prescription rate of intervention drugs 4. Serum total cholesterol, low density lipid cholesterol (LDL) 5. Smoking cessation rates 6. Adherence to booked appointments and self-reported adherence to healthy lifestyle change and drugs | — |
Countries
China
Outcome results
None listed