African Population and Health Research Center, PO Box 10787-00100, Nairobi, Kenya.
Trials. 2013 Dec 1;14:409. doi: 10.1186/1745-6215-14-409.
The burden of cardiovascular disease is rising in sub-Saharan Africa with hypertension being the main risk factor. However, context-specific evidence on effective interventions for primary prevention of cardiovascular diseases in resource-poor settings is limited. This study aims to evaluate the feasibility and cost-effectiveness of one such intervention--the "Sustainable model for cardiovascular health by adjusting lifestyle and treatment with economic perspective in settings of urban poverty".
A prospective quasi-experimental community-based intervention study.
Two slum settlements (Korogocho and Viwandani) in Nairobi, Kenya.
Adults aged 35 years and above in the two communities.
The intervention community (Korogocho) will be exposed to an intervention package for primary prevention of cardiovascular disease that comprises awareness campaigns, household screening for cardiovascular diseases risk factors, and referral and treatment of people with high cardiovascular diseases risk at a primary health clinic. The control community (Viwandani) will continue accessing the usual standard of care for primary prevention of cardiovascular diseases in Kenya.
Demographic and socioeconomic data; anthropometric and clinical measurements including blood pressure. Population-based data will be collected at the baseline and endline--12 months after implementing the intervention. These data will be collected from a random sample of 1,610 adults aged 35 years and above in the intervention and control sites at both baseline and endline. Additionally, operational (including cost) and clinic-based data will be collected on an ongoing basis.
(1) A positive difference in the change in the proportion of the intervention versus control study populations that are at moderate or high risk of cardiovascular disease; (2) a difference in the change in mean systolic blood pressure in the intervention versus control study populations; (3) the net cost of the complete intervention package per disability-adjusted life year gained.
Primary outcomes comparing pre- and post-, and operational data will be analyzed descriptively and "impact" of the intervention will be calculated using double-difference methods. We will also conduct a cost-effectiveness analysis of the intervention using World Health Organization guidelines.
The outcomes of the study will be disseminated to local policy makers and health planners.
Current controlled trials ISRCTN84424579.
在撒哈拉以南非洲，心血管疾病的负担正在增加，高血压是主要的危险因素。然而，在资源匮乏的环境中，针对心血管疾病一级预防的有效干预措施的具体情况证据有限。本研究旨在评估一种干预措施的可行性和成本效益，即“在城市贫困环境中，通过调整生活方式和经济视角来实现心血管健康的可持续模式”。
前瞻性准实验性社区干预研究。
肯尼亚内罗毕的两个贫民窟（Korogocho 和 Viwandani）。
这两个社区中年龄在 35 岁及以上的成年人。
干预社区（Korogocho）将接受心血管疾病一级预防综合干预包，包括宣传活动、家庭心血管疾病危险因素筛查以及在初级保健诊所对高心血管疾病风险人群进行转诊和治疗。对照社区（Viwandani）将继续接受肯尼亚常规的心血管疾病一级预防标准护理。
人口统计学和社会经济学数据；人体测量学和临床测量，包括血压。将在基线和终点（实施干预 12 个月后）收集基于人群的数据。这些数据将从干预和对照点的基线和终点各随机抽取 1610 名年龄在 35 岁及以上的成年人中收集。此外，还将持续收集运营（包括成本）和诊所数据。
（1）干预组与对照组研究人群中处于中高度心血管疾病风险的比例变化差异；（2）干预组与对照组研究人群的平均收缩压变化差异；（3）获得每残疾调整生命年的完整干预包的净成本。
将对比较干预前后的主要结果和运营数据进行描述性分析，并使用双重差异方法计算干预的“影响”。我们还将根据世界卫生组织的指南对干预进行成本效益分析。
将向当地政策制定者和卫生规划人员传播研究结果。
当前对照试验 ISRCTN84424579。
