High Cardiovascular Risk Management and Salt Reduction in Rural Villages in China

Study Overview
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Brief Summary
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Cardiovascular disease is the leading cause of death in China. At the village level, strategies for the control of cardiovascular disease are mostly absent. National clinical guidelines for the management of hypertension and cardiovascular disease are rarely disseminated to, or implemented by, the village primary care providers. Salt reduction has greater potential in rural China than almost anywhere else in the world. Very high levels of salt consumption, very little use of processed food and most dietary salt deriving from home cooking makes the removal of salt from the diet easier, cheaper and more worthwhile than in almost any other setting. The two large-scale cluster-randomized controlled trials proposed here will precisely and reliably define the effect of two highly plausible intervention strategies on important clinical outcomes. The evidence provided by the project will form the basis for policy setting that has the potential to greatly reduce the occurrence of vascular disease in rural China and take an important step towards balancing the rural urban divide in health and healthcare.

Official Title
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China Rural Health Initiative: High Cardiovascular Risk Management and Salt Reduction in Rural Villages in China -- Two Parallel Large Cluster Randomized Controlled Trials

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Behavioral: High-risk patient standardized management package
* Behavioral: Community based salt reduction program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Physician-diagnosed history of coronary heart disease, ischemic stroke, or hemorrhagic stroke, or Older age (50 years or older for men; 60 years or older for women) and having physician-diagnosed Type I or Type II diabetes Older age (50 years or older for men; 60 years or older for women) and systolic blood pressure 160 mmHg (note that for simplicity, diastolic blood pressure is not included in the criteria) Exclusion Criteria: none
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High risk management<br> | Behavioral: High-risk patient standardized management package<br>* A primary-care based high cardiovascular risk management package delivered by village doctors<br>* Other names: high risk management;|
| Experimental: Salt reduction<br> | Behavioral: Community based salt reduction program<br>* A community-based salt reduction program delivered mainly by community health educators<br>* Other names: Salt reduction;|
| Experimental: high risk management and salt reduction<br> | Behavioral: High-risk patient standardized management package<br>* A primary-care based high cardiovascular risk management package delivered by village doctors<br>* Other names: high risk management;Behavioral: Community based salt reduction program<br>* A community-based salt reduction program delivered mainly by community health educators<br>* Other names: Salt reduction;|
| No Intervention: Usual care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean systematic blood pressure level |  | October 2010 - December 2012 | 
| 24 hour urinary sodium |  | October -December 2012 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hour urinary potassium |  | October-December 2012 | 
| Urinary sodium:potassium ratio |  | October-December 2012 | 
| Receiving regular primary care |  | October 2010 -December 2012 | 
| Taking anti-hypertensive medications |  | October 2010 -December 2012 | 
| Taking aspirin |  | October 2010 -December 2012 | 
| Receiving therapeutic lifestyle recommendations from village doctors |  | Oct 2010 - Dec 2012 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High blood pressure, Primary care, Cardiovascular disease prevention, Salt reduction