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

December 13, 2010
April 8, 2014
December 2010
December 2012   (final data collection date for primary outcome measure)
  • 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 ]
Mean blood pressure level [ Time Frame: October - December 2012 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01259700 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
  • 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 ]
Not Provided
 
High Cardiovascular Risk Management and Salt Reduction in Rural Villages in 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Cardiovascular Disease
  • 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
  • Experimental: High risk management
    Intervention: Behavioral: High-risk patient standardized management package
  • Experimental: Salt reduction
    Intervention: Behavioral: Community based salt reduction program
  • Experimental: high risk management and salt reduction
    Interventions:
    • Behavioral: High-risk patient standardized management package
    • Behavioral: Community based salt reduction program
  • No Intervention: Usual care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
10000
June 2014
December 2012   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01259700
Pro00025963, HHSN268200900027C
Yes
The George Institute for Global Health, China
The George Institute for Global Health, China
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Yangfeng Wu, PhD The George Institute for Global Health, China
The George Institute for Global Health, China
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP