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

The George Institute for Global Health, China

Status: Completed

Conditions: Cardiovascular Disease

Treatments: Behavioral: High-risk patient standardized management package; Behavioral: Community based salt reduction program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01259700

HHSN268200900027C (Other Grant/Funding Number)

Pro00025963

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 4 patient groups

High risk management

Experimental group

Treatment:

Behavioral: High-risk patient standardized management package

Salt reduction

Experimental group

Treatment:

Behavioral: Community based salt reduction program

high risk management and salt reduction

Experimental group

Treatment:

Behavioral: Community based salt reduction program

Behavioral: High-risk patient standardized management package

Usual care

No Intervention group