Task Shifting and Blood Pressure Control in Ghana
TASSH
2 other identifiers
interventional
757
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hypertension
Started May 2012
Longer than P75 for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 27, 2013
CompletedFirst Posted
Study publicly available on registry
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedMay 8, 2017
May 1, 2017
4.4 years
February 27, 2013
May 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean change in systolic Blood Pressure (BP)
BP control is defined as BP\<140/90
Baseline to 12 months
Secondary Outcomes (1)
Physical activity levels,change in weight,dietary intake of fruits and vegetables
12 months and 24 months
Study Arms (2)
WHO CVD Risk Assessment package
ACTIVE COMPARATORArm#1 (Intervention Group): Provided Ghana's National Health Insurance and the WHO CVD Risk Assessment package for 12 months.
Health Insurance only
SHAM COMPARATORArm#2 (Control group): Provided Ghana's National Health Insurance for 12 months, brief behavioral counseling at baseline,and usual care.
Interventions
Arm#1 (Intervention Group): Provided Ghana's National Health insurance and the WHO CVD Risk Assessment package for 12 months.
Arm#2 (Control group): Provided Ghana's National Health Insurance for 12 months, brief behavioral counseling at baseline, and usual care.
Eligibility Criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kwame Nkrumah University of Science and Technology
Kumasi, Ghana
Related Publications (4)
Gyamfi J, Allegrante JP, Iwelunmor J, Williams O, Plange-Rhule J, Blackstone S, Ntim M, Apusiga K, Peprah E, Ogedegbe G. Application of the Consolidated Framework for Implementation Research to examine nurses' perception of the task shifting strategy for hypertension control trial in Ghana. BMC Health Serv Res. 2020 Jan 29;20(1):65. doi: 10.1186/s12913-020-4912-5.
PMID: 31996195DERIVEDOgedegbe G, Plange-Rhule J, Gyamfi J, Chaplin W, Ntim M, Apusiga K, Iwelunmor J, Awudzi KY, Quakyi KN, Mogaverro J, Khurshid K, Tayo B, Cooper R. Health insurance coverage with or without a nurse-led task shifting strategy for hypertension control: A pragmatic cluster randomized trial in Ghana. PLoS Med. 2018 May 1;15(5):e1002561. doi: 10.1371/journal.pmed.1002561. eCollection 2018 May.
PMID: 29715303DERIVEDGyamfi J, Plange-Rhule J, Iwelunmor J, Lee D, Blackstone SR, Mitchell A, Ntim M, Apusiga K, Tayo B, Yeboah-Awudzi K, Cooper R, Ogedegbe G. Training nurses in task-shifting strategies for the management and control of hypertension in Ghana: a mixed-methods study. BMC Health Serv Res. 2017 Feb 2;17(1):104. doi: 10.1186/s12913-017-2026-5.
PMID: 28148255DERIVEDOgedegbe G, Plange-Rhule J, Gyamfi J, Chaplin W, Ntim M, Apusiga K, Khurshid K, Cooper R. A cluster-randomized trial of task shifting and blood pressure control in Ghana: study protocol. Implement Sci. 2014 Jun 12;9:73. doi: 10.1186/1748-5908-9-73.
PMID: 24923300DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gbenga Ogedegbe, MD, MS, MPH
NYU Langone Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2013
First Posted
March 1, 2013
Study Start
May 1, 2012
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
May 8, 2017
Record last verified: 2017-05