Task Shifting and Blood Pressure Control in Ghana (TASSH)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01802372
First received: February 27, 2013
Last updated: April 1, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention
Hypertension
High Blood Pressure
Cardiovascular Diseases
Behavioral: WHO CVD risk assessment package
Behavioral: Health Insurance only

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Task Shifting and Blood Pressure Control in Ghana: A Cluster-Randomized Trial

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Mean change in systolic Blood Pressure (BP) [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: No ]
    BP control is defined as BP<140/90


Secondary Outcome Measures:
  • Physical activity levels,change in weight,dietary intake of fruits and vegetables [ Time Frame: 12 months and 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 640
Study Start Date: May 2012
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01802372

Locations
Ghana
Kwame Nkrumah University of Science and Technology
Kumasi, Ghana
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Gbenga Ogedegbe, MD, MS, MPH NYU Langone Medical Center
  More Information

No publications provided by New York University School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01802372     History of Changes
Other Study ID Numbers: i12-01631, 1U01HL114198-01
Study First Received: February 27, 2013
Last Updated: April 1, 2015
Health Authority: Ghana: Committee on Human Research
United States: Institutional Review Board
United States: Federal Government

Keywords provided by New York University School of Medicine:
Hypertension
High Blood Pressure
Cardiovascular Diseases
Health Insurance Coverage
Low income countries
Ghana
Low resource settings
Comparative Effectiveness
Global Health

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypertension
Vascular Diseases

ClinicalTrials.gov processed this record on May 21, 2015