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

This study is ongoing, but not recruiting participants.
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: April 8, 2014
Last verified: April 2014
  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 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.


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: Parallel 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 -- Two Parallel Large Cluster Randomized Controlled Trials

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Mean systematic blood pressure level [ Time Frame: October 2010 - December 2012 ] [ Designated as safety issue: No ]
  • 24 hour urinary sodium [ Time Frame: October -December 2012 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 24 hour urinary potassium [ Time Frame: October-December 2012 ] [ Designated as safety issue: No ]
  • Urinary sodium:potassium ratio [ Time Frame: October-December 2012 ] [ Designated as safety issue: No ]
  • Receiving regular primary care [ Time Frame: October 2010 -December 2012 ] [ Designated as safety issue: No ]
  • Taking anti-hypertensive medications [ Time Frame: October 2010 -December 2012 ] [ Designated as safety issue: No ]
  • Taking aspirin [ Time Frame: October 2010 -December 2012 ] [ Designated as safety issue: No ]
  • Receiving therapeutic lifestyle recommendations from village doctors [ Time Frame: Oct 2010 - Dec 2012 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Knowledge, attitude and behaviour relating to salt consumption [ Time Frame: October-December 2012 ] [ Designated as safety issue: No ]
  • Awareness, treatment, and control of hypertension [ Time Frame: October 2010 - December 2012 ] [ Designated as safety issue: No ]

Estimated Enrollment: 10000
Study Start Date: December 2010
Estimated Study Completion Date: June 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: high risk management
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: April 8, 2014
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 September 22, 2014