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

Sponsor

The George Institute for Global Health, China (Other)

Overall Status

Completed

CT.gov ID

NCT01259700

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

120

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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 :

Dec 1, 2010

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

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 Names: 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 Names: 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 Names: high risk management Behavioral: Community based salt reduction program A community-based salt reduction program delivered mainly by community health educators Other Names: Salt reduction
No Intervention: Usual care

Outcome Measures

Primary Outcome Measures

Mean systematic blood pressure level [October 2010 - December 2012]
24 hour urinary sodium [October -December 2012]

Secondary Outcome Measures

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]

Other Outcome Measures

Knowledge, attitude and behaviour relating to salt consumption [October-December 2012]
Awareness, treatment, and control of hypertension [October 2010 - December 2012]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

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