China Rural Health Initiative Follow up Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9,164
- 试验地点
- 5
- 主要终点
- mean systolic blood pressure level among all participants and those at high risk
研究概览
简要总结
China Rural Health Initiative (CRHI), a large-scale, factorial, cluster-randomized, controlled trial was conducted in 120 villages selected from 5 Northern Provinces of rural China between 2010 and 2012. Two interventions were evaluated through CRHI. One is the standard disease management program of individuals at high risk of cardiovascular disease delivered by Primary Care Providers (village doctors). Another one is a community-based Salt Reduction program delivered by community health educators. CRHI study interventions had ended for two years now and provide a good opportunity for us to understand whether its effects could be prolonged to a longer term. This study wants to evaluate the effects of CRHI interventions at 2 years after the end of CRHI (from Sep 2014 to Feb 2015).
In this follow-up survey, the baseline cohort of 5050 and post-intervention cohort of 4887 CRHI participants who were randomly selected from the 120 villages from 5 northern provinces of rural China will be recruited for the follow up study from Sep 2014 to Feb 2015. A questionnaire derived from CRHI baseline and post-intervention surveys will be used to collect data on disease history, medication use, care seeking patterns, lifestyle factors and so on. Weight, height, blood pressure and heart rate will be measured in the standard ways.
详细描述
"1."Background and Significance Cardiovascular disease (CVD) remains the number one global cause of death, accounting for 17.3 million deaths per year, a number that is expected to grow to 23.6 million by 2030. 80% of these deaths occur in low- and middle-income countries. These deaths were usually at younger ages compared to higher income countries.
CVD is the leading cause of death in China, responsible for approximately 3.5 million (41%) deaths in 2012. Reflecting the major contribution of cerebrovascular disease to the vascular disease burden in China, high blood pressure is the leading modifiable risk factor for cardiovascular disease and its importance is greatest in rural and northern regions where high blood pressure,salt consumption and the incidence of stroke are all very high.
Given the background above, China Rural Health Initiative, a large-scale, factorial, cluster-randomized, controlled trial was conducted in 120 villages selected from 5 Northern Provinces (Liaoning, Hebei, Shanxi, Shaanxi and Ningxia) of rural China between 2010 and 2012. CRHI aimed to develop, implement and evaluate effective, low-cost, and sustainable interventions for cardiovascular disease prevention and management suitable for widespread implementation in rural China. Two interventions were evaluated through CRHI. One is the standard disease management program of individuals at high risk of cardiovascular disease delivered by Primary Care Providers (village doctors) ('PCP' hereafter). Another one is a community-based Salt Reduction program delivered by community health educators ('SRS' hereafter).
A stratified randomization was used to assign the villages into 4 groups: PCP only, SRS only, both PCP and SRS, and usual care (neither PCP nor SRS). For the entire study, there were 60 villages with 'PCP' and 60 villages with 'no PCP' (with or without SRS) and 60 villages with 'SRS' and 60 villages with 'no SRS' (with or without PCP). For the PCP intervention, the period of intervention was 2 years; and for the SRS, approximately 1.5 years. And both interventions ended in November, 2012.
High risk individuals were defined as those meeting any one of the following criteria, regardless of current medication use:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals had participated the baseline or post-intervention survey.
排除标准
- 未提供
结局指标
主要结局
mean systolic blood pressure level among all participants and those at high risk
时间窗: from baseline and post-intervention to the follow up
次要结局
- Proportion of individuals regularly visiting the village clinic among all participants and high-risk patients(from baseline and post-intervention to the follow up)
- Proportion of individuals developing CVD event among all participants and high-risk patients(from baseline and post-intervention to the follow up)
- Proportion of individuals treated with aspirin among all participants and high-risk patients(from baseline and post-intervention to the follow up)
- Proportion of individuals receiving lifestyle advice among all participants and high-risk patients(from baseline and post-intervention to the follow up)
- Proportion of individuals treated with a blood pressure lowering agent among all participants and high-risk patients(from baseline and post-intervention to the follow up)
- Proportion of individuals having knowledge on salt reduction among all participants and high-risk patients(from baseline and post-intervention to the follow up)
- Proportion of individuals using low sodium salt among all participants and high-risk patients(from baseline and post-intervention to the follow up)
- Proportion of individuals adopting healthy behavior among all participants and high-risk patients(from baseline and post-intervention to the follow up)