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Completed

NCT Number: NCT01802372

Task Shifting and Blood Pressure Control in Ghana

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kwame Nkrumah University of Science and Technology

Kumasi, Ghana

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Health facility Inclusion: Participating health facilities will be selected from areas that are geographically distant from one another with equal urban/rural mix in the Ashanti Region, which has 170 community health centers. Of these, we will recruit 32 for this study. Eligible facilities must have at least one community health nurse employed in the CHPS program; be a certified National Health Insurance Scheme (NHIS) provider; and have basic capability for blood tests.
  • Patient Inclusion: To be eligible for the study, patients must fulfill the following criteria: a) are registered to receive care at the health center; b) are adults age 40 years and older; c) have BP 140-179/90-100 mm Hg and are not on treatment for hypertension; and c) can provide informed consent. Given low literacy levels, consent will be provided both verbally and in written form.

Exclusion criteria

-Patients will be excluded if they have: a) previous diagnosis of diabetes, coronary artery disease, transient ischemic attacks, stroke, heart failure, or angina: b) BP>180/100 mm Hg; c) positive urine dipstick for protein; d) are pregnant; and e) unable to comply with the follow-up requirements or provide informed consent. Patients with history of transient ischemic attacks (TIAs), stroke, heart failure, diabetes, angina, claudication, and BP>180/100 mm Hg will be referred to the district hospitals for further management.

Treatment and study plan

WHO CVD risk assessment package

Behavioral

Arm#1 (Intervention Group): Provided Ghana's National Health insurance and the WHO CVD Risk Assessment package for 12 months.

Health Insurance only

Behavioral

Arm#2 (Control group): Provided Ghana's National Health Insurance for 12 months, brief behavioral counseling at baseline, and usual care.

Primary outcomes

  1. Mean change in systolic Blood Pressure (BP)

    Time frame: Baseline to 12 months

    BP control is defined as BP<140/90

Secondary outcomes

  1. Physical activity levels,change in weight,dietary intake of fruits and vegetables

    Time frame: 12 months and 24 months

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Acronym: TASSH

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Mar 1, 2013
Registry last updated
May 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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