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

Not Applicable

Completed

• Conditions: Cardiovascular Disease
• Interventions: Behavioral: Community based salt reduction program; Behavioral: High-risk patient standardized management package

• Registration Number: NCT01259700
• Lead Sponsor: The George Institute for Global Health, China

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-13
• Study First Submitted QC: 2010-12-13
• Study First Posted: 2010-12-14
• Primary Completion: 2012-12
• Study Completion: 2014-06
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-15
• Last Update Posted: 2016-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Salt reduction	Community based salt reduction program	-
high risk management and salt reduction	High-risk patient standardized management package	-
high risk management and salt reduction	Community based salt reduction program	-
High risk management	High-risk patient standardized management package	-

Primary Outcome Measures

Name	Time	Method
Mean systematic blood pressure level	October 2010 - December 2012
24 hour urinary sodium	October -December 2012

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Ningxia Medical University School of Public Health; 🇨🇳 Yinchuan, Ningxia, China

The First Hospital Of China Medical University; 🇨🇳 Shenyang, Liaoning, China

Hebei Province Center for Disease Prevention and Control ,China; 🇨🇳 Shijiazhuang, Hebei, China

Changzhi Medical College, China; 🇨🇳 Changzhi, Shanxi, China

The Xi'an Jiaotong University School of Public Health; 🇨🇳 Xi'an, Shanxi, China