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

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ClinicalTrials.gov Identifier: NCT01259700
Recruitment Status : Completed
First Posted : December 14, 2010
Last Update Posted : February 17, 2016
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
The George Institute for Global Health, China

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Behavioral: High-risk patient standardized management package Behavioral: Community based salt reduction program Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sodium

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Mean systematic blood pressure level [ Time Frame: October 2010 - December 2012 ]
  2. 24 hour urinary sodium [ Time Frame: October -December 2012 ]

Secondary Outcome Measures :
  1. 24 hour urinary potassium [ Time Frame: October-December 2012 ]
  2. Urinary sodium:potassium ratio [ Time Frame: October-December 2012 ]
  3. Receiving regular primary care [ Time Frame: October 2010 -December 2012 ]
  4. Taking anti-hypertensive medications [ Time Frame: October 2010 -December 2012 ]
  5. Taking aspirin [ Time Frame: October 2010 -December 2012 ]
  6. Receiving therapeutic lifestyle recommendations from village doctors [ Time Frame: Oct 2010 - Dec 2012 ]

Other Outcome Measures:
  1. Knowledge, attitude and behaviour relating to salt consumption [ Time Frame: October-December 2012 ]
  2. Awareness, treatment, and control of hypertension [ Time Frame: October 2010 - December 2012 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01259700


Locations
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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
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Yangfeng Wu, PhD The George Institute for Global Health, China
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: The George Institute for Global Health, China
ClinicalTrials.gov Identifier: NCT01259700    
Other Study ID Numbers: Pro00025963
HHSN268200900027C ( Other Grant/Funding Number: US NIH NHLBI (BAA contract) )
First Posted: December 14, 2010    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016
Keywords provided by The George Institute for Global Health, China:
High blood pressure
Primary care
Cardiovascular disease prevention
Salt reduction
Additional relevant MeSH terms:
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Cardiovascular Diseases