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).
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.
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