High Cardiovascular Risk Management and Salt Reduction in Rural Villages in China-a Factorial Cluster-randomized Controlled Trial

This study is currently recruiting participants.
Verified September 2011 by The George Institute for Global Health, China
Sponsor:
Collaborator:
Information provided by (Responsible Party):
The George Institute for Global Health, China
ClinicalTrials.gov Identifier:
NCT01259700
First received: December 13, 2010
Last updated: September 2, 2011
Last verified: September 2011
  Purpose

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 large-scale cluster-randomized controlled 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.


Condition Intervention
Cardiovascular Disease
Behavioral: High-risk patient standardized management package
Behavioral: Community based salt reduction program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: China Rural Health Initiative: High Cardiovascular Risk Management and Salt Reduction in Rural Villages in China -- a Factorial Cluster-randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by The George Institute for Global Health, China:

Primary Outcome Measures:
  • Mean blood pressure level [ Time Frame: October - December 2012 ] [ Designated as safety issue: No ]

Estimated Enrollment: 10000
Study Start Date: December 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Package Behavioral: High-risk patient standardized management package
A primary-care based high cardiovascular risk management package delivered by village doctors
Other Name: Package
Experimental: Salt reduction Behavioral: Community based salt reduction program
A community-based salt reduction program delivered mainly by community health educators
Other Name: Salt reduction
Experimental: Package and salt reduction Behavioral: High-risk patient standardized management package
A primary-care based high cardiovascular risk management package delivered by village doctors
Other Name: Package
Behavioral: Community based salt reduction program
A community-based salt reduction program delivered mainly by community health educators
Other Name: Salt reduction
No Intervention: Usual care

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01259700

Contacts
Contact: Lijing Yan, PhD +86 10 8280 0577 ylijing@georgeinstitute.org.cn

Locations
China, Hebei
Hebei Province Center for Disease Prevention and Control ,China Recruiting
Shijiazhuang, Hebei, China
Contact: Jixin Sun, PhD     +86 15176159538     sunjixin666@hotmail.com    
Principal Investigator: Jianxin Zhang, PhD            
China, Liaoning
The First Hospital Of China Medical University Recruiting
Shenyang, Liaoning, China
Contact: Bo Zhou, PhD     +86 13709826820     ripple_zhou@126.com    
Principal Investigator: Jingpu Shi, PhD            
China, Ningxia
Ningxia Medical University School of Public Health Recruiting
Yinchuan, Ningxia, China
Contact: Jihong Hu, PhD     +86 15209693996     hujihonghappy@163.com    
Principal Investigator: Yuhong Zhang, PhD            
China, Shannxi
The Xi'an Jiaotong University School of Public Health Recruiting
Xi'an, Shannxi, China
Contact: Yan Yu, PhD     +86 13087506658     yuyan@mail.xjtu.edu.cn    
Principal Investigator: Ruijuan Zhang, PhD            
China, Shanxi
Changzhi Medical College, China Recruiting
Changzhi, Shanxi, China
Contact: Zhifang Li, PhD     +86 13593290118     lzfmuzi@yahoo.com.cn    
Principal Investigator: Xiangxian Feng, PhD            
Sponsors and Collaborators
The George Institute for Global Health, China
Investigators
Principal Investigator: Yangfeng Wu, PhD The George Institute for Global Health, China
  More Information

No publications provided

Responsible Party: The George Institute for Global Health, China
ClinicalTrials.gov Identifier: NCT01259700     History of Changes
Other Study ID Numbers: Pro00025963, HHSN268200900027C
Study First Received: December 13, 2010
Last Updated: September 2, 2011
Health Authority: China: Ethics Committee
United States: Institutional Review Board

Keywords provided by The George Institute for Global Health, China:
High blood pressure
Primary care
Cardiovascular disease prevention
Salt reduction

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013