Task Shifting and Blood Pressure Control in Ghana (TASSH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01802372|
Recruitment Status : Completed
First Posted : March 1, 2013
Last Update Posted : May 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hypertension High Blood Pressure Cardiovascular Diseases||Behavioral: WHO CVD risk assessment package Behavioral: Health Insurance only||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||757 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Task Shifting and Blood Pressure Control in Ghana: A Cluster-Randomized Trial|
|Actual Study Start Date :||May 1, 2012|
|Actual Primary Completion Date :||October 1, 2016|
|Actual Study Completion Date :||October 1, 2016|
Active Comparator: 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: 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.
Sham Comparator: Health Insurance only
Arm#2 (Control group): Provided Ghana's National Health Insurance for 12 months, brief behavioral counseling at baseline,and usual care.
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.
- Mean change in systolic Blood Pressure (BP) [ Time Frame: Baseline to 12 months ]BP control is defined as BP<140/90
- Physical activity levels,change in weight,dietary intake of fruits and vegetables [ Time Frame: 12 months and 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01802372
|Kwame Nkrumah University of Science and Technology|
|Principal Investigator:||Gbenga Ogedegbe, MD, MS, MPH||NYU Langone Medical Center|