Skip to main content
OpenTrials
Completed

NCT Number: NCT01259700

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hebei Province Center for Disease Prevention and Control ,China, Shijiazhuang, Hebei, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-risk patient standardized management package

Behavioral

A primary-care based high cardiovascular risk management package delivered by village doctors

Other names: high risk management

Community based salt reduction program

Behavioral

A community-based salt reduction program delivered mainly by community health educators

Other names: Salt reduction

Primary outcomes

  1. Mean systematic blood pressure level

    Time frame: October 2010 - December 2012

  2. 24 hour urinary sodium

    Time frame: October -December 2012

Secondary outcomes

  1. 24 hour urinary potassium

    Time frame: October-December 2012

  2. Urinary sodium:potassium ratio

    Time frame: October-December 2012

  3. Receiving regular primary care

    Time frame: October 2010 -December 2012

  4. Taking anti-hypertensive medications

    Time frame: October 2010 -December 2012

  5. Taking aspirin

    Time frame: October 2010 -December 2012

  6. Receiving therapeutic lifestyle recommendations from village doctors

    Time frame: Oct 2010 - Dec 2012

Other outcomes

  1. Knowledge, attitude and behaviour relating to salt consumption

    Time frame: October-December 2012

  2. Awareness, treatment, and control of hypertension

    Time frame: October 2010 - December 2012

Sponsors and collaborators

Lead sponsor

The George Institute for Global Health, China

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2014
First posted
Dec 14, 2010
Registry last updated
Feb 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.