NCT01802372

Task Shifting and Blood Pressure Control in Ghana

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 757 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to evaluate the comparative effectiveness of the World Health Organization Package targeted at Cardiovascular (CV) risk assessment and hypertension control, delivered by Community Health Nurses as part of Ghana's Community based Health Planning and Services program, versus provision of health insurance coverage, on blood pressure 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.

Detailed description

Countries in sub-Saharan Africa (SSA) are experiencing an epidemic of cardiovascular disease (CVD) propelled by rapidly increasing rates of hypertension. Barriers to hypertension control in SSA include poor access to care and high out-of-pocket costs. Although SSA bears 24% of the global disease burden, it has only 3% of the global health workforce. Given such limited resources, cost-effective strategies, such as task shifting, are needed to mitigate the rising CVD epidemic in SSA. Ghana, a country in SSA with an established community health worker program integrated within a national health insurance scheme provides an ideal platform to evaluate implementation of the World Health Organization (WHO) task-shifting strategy. This study will evaluate the comparative effectiveness of the implementation of the WHO Package targeted at CV risk assessment versus provision of health insurance coverage,on blood pressure (BP) reduction. Using a cluster randomized design, 32 community health centers (CHCs) and district hospitals in Ghana will be randomized to either the intervention group (16 CHCs) or the control group (16 CHCs). A total of 640 patients with uncomplicated hypertension (BP 140-179/90-99 mm Hg and absence of target organ damage) will be enrolled in this study (20 patients per CHC). The intervention consists of WHO Package of CV risk assessment, patient education, initiation and titration of antihypertensive medications, behavioral counseling on lifestyle behaviors, and medication adherence every three months for 12 months. The primary outcome is the mean change in systolic BP from baseline to 12 months. The secondary outcomes are rates of 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. All outcomes will be assessed at baseline, six months and 12 months. Trained community health nurses will deliver the intervention as part of Ghana's community-based health planning and services (CHPS) program. Findings from this study will provide policy makers and other stakeholders needed information to recommend scalable and cost-effective policy with respect to comprehensive CV risk reduction and hypertension control in resource-poor settings.

Conditions

• Hypertension
• High Blood Pressure
• Cardiovascular Diseases

Interventions

Type	Name	Description
BEHAVIORAL	WHO CVD risk assessment package	Arm#1 (Intervention Group): Provided Ghana's National Health insurance and the WHO CVD Risk Assessment package for 12 months.
BEHAVIORAL	Health Insurance only	Arm#2 (Control group): Provided Ghana's National Health Insurance for 12 months, brief behavioral counseling at baseline, and usual care.

Timeline

• Start date: 2012-05-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2013-03-01
• Last updated: 2017-05-08

Locations

1 site across 1 country: Ghana