Task Shifting and Blood Pressure Control in Ghana (TASSH)

This study is currently recruiting participants.
Verified February 2013 by New York University School of Medicine
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01802372
First received: February 27, 2013
Last updated: January 23, 2014
Last verified: February 2013
  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 and Health Insurance
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: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: WHO CVD risk assessment package and Health Insurance
Arm#1 (Intervention Group): Provided Ghana's National Health insurance for 12 months. Intervention group will also receive the WHO Package delivered by trained community health nurses as part of the widespread Community based Health Planning and Services (CHPS) program in Ghana. The package includes CV risk assessment, BP readings,Medication adjustment, and Behavioral counseling. Follow-up is at 3 months intervals for one-year and again at 24 months.
Behavioral: WHO CVD risk assessment package and Health Insurance
Sham Comparator: Health Insurance only
Arm#2 (Control group): Provided Ghana's National Health Insurance for 12 months. Patients in this group will also receive brief behavioral counseling at baseline and continue with usual care. Follow-up is at 3 months intervals for one-year and again at 24 months.
Behavioral: Health Insurance only

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

Contacts
Contact: Gbenga Ogedegbe, MD, MS, MPH olugbenga.ogedegbe@nyumc.org
Contact: Joyce Gyamfi, MS joyce.gyamfi@nyumc.org

Locations
Ghana
Kwame Nkrumah University of Science and Technology Recruiting
Kumasi, Ghana
Contact: Jacob Plange-Rhule, MB ChB, PhD         
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

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01802372     History of Changes
Other Study ID Numbers: 1U01HL114198-01
Study First Received: February 27, 2013
Last Updated: January 23, 2014
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

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypertension
Vascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014