High Cardiovascular Risk Management and Salt Reduction in Rural Villages in China-a Factorial Cluster-randomized Controlled Trial
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Purpose
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 large-scale cluster-randomized controlled 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 | Intervention |
|---|---|
|
Cardiovascular Disease |
Behavioral: High-risk patient standardized management package Behavioral: Community based salt reduction program |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | China Rural Health Initiative: High Cardiovascular Risk Management and Salt Reduction in Rural Villages in China -- a Factorial Cluster-randomized Controlled Trial |
- Mean blood pressure level [ Time Frame: October - December 2012 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 10000 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Package |
Behavioral: High-risk patient standardized management package
A primary-care based high cardiovascular risk management package delivered by village doctors
Other Name: Package
|
| 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: Package 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: Package
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 |
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Lijing Yan, PhD | +86 10 8280 0577 | ylijing@georgeinstitute.org.cn |
| China, Hebei | |
| Hebei Province Center for Disease Prevention and Control ,China | Recruiting |
| Shijiazhuang, Hebei, China | |
| Contact: Jixin Sun, PhD +86 15176159538 sunjixin666@hotmail.com | |
| Principal Investigator: Jianxin Zhang, PhD | |
| China, Liaoning | |
| The First Hospital Of China Medical University | Recruiting |
| Shenyang, Liaoning, China | |
| Contact: Bo Zhou, PhD +86 13709826820 ripple_zhou@126.com | |
| Principal Investigator: Jingpu Shi, PhD | |
| China, Ningxia | |
| Ningxia Medical University School of Public Health | Recruiting |
| Yinchuan, Ningxia, China | |
| Contact: Jihong Hu, PhD +86 15209693996 hujihonghappy@163.com | |
| Principal Investigator: Yuhong Zhang, PhD | |
| China, Shannxi | |
| The Xi'an Jiaotong University School of Public Health | Recruiting |
| Xi'an, Shannxi, China | |
| Contact: Yan Yu, PhD +86 13087506658 yuyan@mail.xjtu.edu.cn | |
| Principal Investigator: Ruijuan Zhang, PhD | |
| China, Shanxi | |
| Changzhi Medical College, China | Recruiting |
| Changzhi, Shanxi, China | |
| Contact: Zhifang Li, PhD +86 13593290118 lzfmuzi@yahoo.com.cn | |
| Principal Investigator: Xiangxian Feng, PhD | |
| Principal Investigator: | Yangfeng Wu, PhD | The George Institute for Global Health, China |
More Information
No publications provided
| Responsible Party: | The George Institute for Global Health, China |
| ClinicalTrials.gov Identifier: | NCT01259700 History of Changes |
| Other Study ID Numbers: | Pro00025963, HHSN268200900027C |
| Study First Received: | December 13, 2010 |
| Last Updated: | September 2, 2011 |
| Health Authority: | China: Ethics Committee United States: Institutional Review Board |
Keywords provided by The George Institute for Global Health, China:
|
High blood pressure Primary care Cardiovascular disease prevention Salt reduction |
Additional relevant MeSH terms:
|
Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 21, 2013