Task Shifting and Blood Pressure Control in Ghana: A Cluster- Randomized Trial.

加纳的任务转移和血压控制：整群随机试验。

基本信息

批准号：
8318334
负责人：
OLUGBENGA G. OGEDEGBE
金额：
$ 29.27万
依托单位：
NEW YORK UNIVERSITY SCHOOL OF MEDICINE
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-05-04 至 2017-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8318334
关键词：
Address Africa South of the Sahara Algorithms Antihypertensive Agents Behavior Behavior Therapy Blood Pressure Body Weight decreased Cardiovascular Diseases Caring Cessation of life Chronic Disease Clinical Clinical Trials Design Collaborations Communities Community Health Community Health Centers Community Health Nurse Specialist Community Health Nursing Consultations Control Groups Counseling Country Devices Diastolic blood pressure Dietary intake Disease Effectiveness Enrollment Epidemic Food Ghana Goals Guidelines Health Health Insurance Health Personnel Health Planning Health Services Healthcare Systems Hour Hypertension Income Institutes Insurance Coverage Intake Intervention Laboratories Life Style Medical Medical center Morbidity - disease rate National Health Insurance Outcome Patient Education Patients Penetration Pharmaceutical Preparations Physical activity Physicians Policies Policy Maker Population Primary Health Care Program Evaluation Questionnaires Randomized Reading Resources Risk Risk Assessment Risk Management Risk Reduction Schedule Scheme Science Self Management Services System Technology Testing Titrations Training Treatment Protocols Uninsured Universities Ursidae Family Visit Weight World Health Organization base blood pressure regulation burden of illness cardiovascular disorder prevention cardiovascular disorder risk cardiovascular risk factor comparative effectiveness cost cost effective data management experience fruits and vegetables global health group intervention hypertension control improved intervention effect medical schools medication compliance mortality payment primary outcome programs randomized trial secondary outcome skills socioeconomics

项目摘要

DESCRIPTION (provided by applicant): Ghana and other countries in sub-Saharan Africa (SSA) are experiencing an epidemic of cardiovascular diseases (CVD) propelled by rapidly increasing rates of hypertension. Socioeconomic barriers, lack of insurance coverage, and shortage of physicians limit the capacity of SSA countries to implement CVD prevention. Task shifting of primary care duties from physicians to non-physician health care providers is a potentially cost-effective strategy for mitigating systems-level barriers to optimal hypertension control in SSA. In this regard, the WHO developed and successfully evaluated the effectiveness of a WHO Package targeted at CV risk assessment and hypertension control, delivered by community health nurses (CHNs) in low resource settings. However widespread implementation of the WHO Package has not been evaluated in SSA. The availability in Ghana, of national health insurance scheme for uninsured patients, and widespread implementation of Community-based Health Planning and Services (CHPS) program that uses CHNs, for delivery of primary care services, presents a unique opportunity to evaluate the impact of both strategies on hypertension control. Thus, we propose a cluster randomized trial to evaluate the comparative effectiveness of the WHO CVD risk management package for hypertension control delivered by CHNs as part of Ghana's CHPS program plus provision of health insurance coverage (Intervention Group; IG), versus provision of health insurance coverage alone (Control Group; CG), on BP reduction among 640 patients with uncontrolled hypertension. Thirty-two community health centers (CHCs) in Ghana will be randomly assigned to either the IG (N=16) or the CG (N=16). The intervention includes CV risk assessment using the WHO risk chart, initiation and titration of protocolized antihypertensive medications, counseling on lifestyle modification, self- management skills and medication adherence. The intervention will occur every 3 months for 12 months during scheduled study visits at baseline, 3, 6, 9 and 12 months. The primary outcome is the mean change in systolic BP from baseline to 12 months. The secondary outcomes are proportion of patients with adequate BP control at 12 months; levels of physical activity, percent change in weight, and dietary intake of fruits and vegetables at 12 months; and sustainability of intervention effects at 24 months. BP control is defined as BP<140/90 mm Hg following JNC-7 guidelines. BP readings will be assessed with a validated automated BP device. Physical activity will be assessed with the Global Physical Activity Questionnaire and dietary intake will be assessed with 24-hour food recall. All outcomes will be assessed at baseline, 6 months and 12 months. This proposal is a collaboration between the WHO (technical partners responsible for training the CHNs in delivery of the WHO Package), Ghana Regional Health Care Services (will assure enrollment of the CHCs), Kwame Nkrumah University of Science and Technology (provide local oversight of the program), Loyola Medical Center and NYU School of Medicine (provide oversight, data management, and program evaluation). RELEVANCE: Interventions targeted at blood pressure control are urgently needed to address the CVD epidemic in and its associated morbidity, mortality, and societal costs in Sub-Saharan Africa. Using a cluster randomized trial design among 640 hypertensive patients followed in 32 Community Health Centers in Ghana, the goal of the proposed study is to evaluate the comparative effectiveness of the WHO Package targeted at CV risk assessment and hypertension control, delivered by CHNs as part of Ghana's Community based Health Planning and Services program, versus provision of health insurance coverage, on BP reduction. Findings from this study will provide policy makers and other stakeholders needed information to recommend efficient cost-effective policy with regards to comprehensive CV risk reduction in patients with hypertension in low resource settings.

描述（由申请人提供）：加纳和撒哈拉以南非洲（SSA）的其他国家正在经历通过快速增加高血压率迅速提高的心血管疾病（CVD）流行。社会经济障碍，缺乏保险范围和医生短缺限制了SSA国家实施CVD预防的能力。从医师到非医学医疗保健提供者将初级保健职责的任务转移是缓解SSA最佳高血压控制的系统级别障碍的潜在具有成本效益的策略。在这方面，谁开发并成功地评估了针对CV风险评估和高血压控制的WHO计划的有效性，该计划由社区卫生护士（CHN）在低资源环境中提供。但是，在SSA中尚未评估WHO软件包的广泛实施。加纳的无保险患者国家健康保险计划的可用性以及使用CHN，提供基于CHN的社区健康计划和服务（CHP）计划的广泛实施，提供了一个独特的机会来评估两种策略对高血压控制的影响。因此，我们提出了一项群集随机试验，以评估CHN作为加纳CHPS计划的一部分以及提供健康保险的提供（IG IG），与单独提供健康保险覆盖的健康保险（IG）相比（对照组； CG），在640名患者中，不使用健康保险，对健康保险覆盖率（IG）提供了比较有效性，以作为加纳的CHPS计划以及提供健康保险覆盖率的提供（IG IGS； IG）。加纳的32个社区卫生中心（CHC）将随机分配给IG（n = 16）或CG（n = 16）。该干预措施包括使用WHO风险图表的简历风险评估，协议的降压药物的启动和滴定，有关生活方式修改，自我管理技能和药物遵守的咨询。在基线3、6、9和12个月的预定研究访问期间，干预措施每3个月每3个月进行12个月。主要结果是收缩压从基线到12个月的平均变化。次要结果是在12个月时具有足够BP对照的患者的比例； 12个月的体育锻炼水平，体重变化百分比以及水果和蔬菜的饮食摄入量；和干预效果的可持续性在24个月时。根据JNC-7指南，BP控制定义为BP <140/90 mm Hg。 BP读数将通过经过验证的自动化BP设备进行评估。将通过全球体育锻炼问卷评估体育锻炼，饮食摄入量将通过24小时的食物召回来评估。所有结果将在基线，6个月零12个月时进行评估。这项建议是WHO（负责培训WHO包裹提供CHN的技术合作伙伴），加纳地区医疗保健服务（将确保CHC的入学率），Kwame Nkrumah科学技术大学的招生（提供该计划的本地监督），Loyola医学中心和NYU医学中心和NYU医学中心（提供监督，数据管理和计划管理和计划评估）。相关性：迫切需要针对血压控制的干预措施来解决撒哈拉以南非洲的CVD流行及其相关的发病率，死亡率和社会成本。拟议的研究的目标是使用640名高血压患者进行簇随机试验设计，然后在加纳的32个社区保健中心中进行了研究，是评估针对CV风险评估和高血压控制的WHO包装的比较有效性，CHN作为Ghana社区健康计划和基于医疗保险的医疗保险保险覆盖的CHN提供的一部分。这项研究的发现将为决策者和其他利益相关者提供所需的信息，以推荐有效的成本效益政策。在低资源环境中高血压患者的全面降低CV风险。