China Rural Health Initiative: High Cardiovascular Risk Management and Salt Reduction in Rural Villages in China -- Two Parallel Large Cluster Randomized Controlled Trials

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

Sponsors

Lead sponsor: The George Institute for Global Health, China

Collaborator: National Heart, Lung, and Blood Institute (NHLBI)

Source 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.

Overall Status Completed
Start Date December 2010
Completion Date June 2014
Primary Completion Date December 2012
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Mean systematic blood pressure level October 2010 - December 2012
24 hour urinary sodium October -December 2012
Secondary Outcome
Measure Time Frame
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
Enrollment 120
Condition
Intervention

Intervention type: Behavioral

Intervention name: High-risk patient standardized management package

Description: A primary-care based high cardiovascular risk management package delivered by village doctors

Other name: high risk management

Intervention type: Behavioral

Intervention name: Community based salt reduction program

Description: A community-based salt reduction program delivered mainly by community health educators

Other name: Salt reduction

Eligibility

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

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Yangfeng Wu, PhD Principal Investigator The George Institute for Global Health, China
Location
facility
Hebei Province Center for Disease Prevention and Control ,China | Shijiazhuang, Hebei, China
The First Hospital Of China Medical University | Shenyang, Liaoning, China
Ningxia Medical University School of Public Health | Yinchuan, Ningxia, China
Changzhi Medical College, China | Changzhi, Shanxi, China
The Xi'an Jiaotong University School of Public Health | Xi'an, Shanxi, China
Location Countries

China

Verification Date

February 2016

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Arm group label: High risk management

Arm group type: Experimental

Arm group label: Salt reduction

Arm group type: Experimental

Arm group label: high risk management and salt reduction

Arm group type: Experimental

Arm group label: Usual care

Arm group type: No Intervention

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov