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

February 15, 2016 updated by: The George Institute for Global Health, China

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hebei
      • Shijiazhuang, Hebei, China
        • Hebei Province Center for Disease Prevention and Control ,China
    • Liaoning
      • Shenyang, Liaoning, China
        • The First Hospital of China Medical University
    • Ningxia
      • Yinchuan, Ningxia, China
        • Ningxia Medical University School of Public Health
    • Shanxi
      • Changzhi, Shanxi, China
        • Changzhi Medical College, China
      • Xi'an, Shanxi, China
        • The Xi'an Jiaotong University School of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Knowledge, attitude and behaviour relating to salt consumption
Time Frame: October-December 2012
October-December 2012
Awareness, treatment, and control of hypertension
Time Frame: October 2010 - December 2012
October 2010 - December 2012

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The George Institute for Global Health, China

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Yangfeng Wu, PhD, The George Institute for Global Health, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

December 13, 2010

First Submitted That Met QC Criteria

December 13, 2010

First Posted (Estimate)

December 14, 2010

Study Record Updates

Last Update Posted (Estimate)

February 17, 2016

Last Update Submitted That Met QC Criteria

February 15, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00025963
  • HHSN268200900027C (Other Grant/Funding Number: NHLBI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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