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

Cardiovascular Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01259700
• Other study ID #: Pro00025963
• Secondary ID: HHSN268200900027
• Status: Completed
• Phase: N/A
• First received: December 13, 2010
• Last updated: February 15, 2016
• Start date: December 2010
• Est. completion date: June 2014

Study information

• Verified date: February 2016
• Source: The George Institute for Global Health, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics CommitteeUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2014
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Behavioral:
• High-risk patient standardized management package
A primary-care based high cardiovascular risk management package delivered by village doctors
• Community based salt reduction program
A community-based salt reduction program delivered mainly by community health educators

Locations

Country	Name	City	State
China	Changzhi Medical College, China	Changzhi	Shanxi
China	The First Hospital Of China Medical University	Shenyang	Liaoning
China	Hebei Province Center for Disease Prevention and Control ,China	Shijiazhuang	Hebei
China	The Xi'an Jiaotong University School of Public Health	Xi'an	Shanxi
China	Ningxia Medical University School of Public Health	Yinchuan	Ningxia

Sponsors (2)

Lead Sponsor	Collaborator
The George Institute for Global Health, China	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Knowledge, attitude and behaviour relating to salt consumption		October-December 2012	No
Other	Awareness, treatment, and control of hypertension		October 2010 - December 2012	No
Primary	Mean systematic blood pressure level		October 2010 - December 2012	No
Primary	24 hour urinary sodium		October -December 2012	No
Secondary	24 hour urinary potassium		October-December 2012	No
Secondary	Urinary sodium:potassium ratio		October-December 2012	No
Secondary	Receiving regular primary care		October 2010 -December 2012	No
Secondary	Taking anti-hypertensive medications		October 2010 -December 2012	No
Secondary	Taking aspirin		October 2010 -December 2012	No
Secondary	Receiving therapeutic lifestyle recommendations from village doctors		Oct 2010 - Dec 2012	No