HypertensionTASSHNCT01802372
Task Shifting and Blood Pressure Control in Ghana
A study testing WHO CVD risk assessment package and Health Insurance only in people with Hypertension and High Blood Pressure, run by NYU Langone Health at 1 site in Ghana.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Hypertension, High Blood Pressure, Cardiovascular Diseases
- What is being tested?
- WHO CVD risk assessment package and Health Insurance only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 757 participants
- Where
- 1 siteGhana
- Study dates
- 1 May 2012to 1 Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Task Shifting and Blood Pressure Control in Ghana: A Cluster-Randomized Trial
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.
Read the 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.
- Conditions
- Hypertension, High Blood Pressure, Cardiovascular Diseases
- Being tested
- WHO CVD risk assessment package, Health Insurance only
- Keywords
- Hypertension, High Blood Pressure, Cardiovascular Diseases, Health Insurance Coverage, Low income countries, Ghana, Low resource settings, Comparative Effectiveness, Global Health
- Medical subject headings
- Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WHO CVD risk assessment packageBehavioural
Arm#1 (Intervention Group): Provided Ghana's National Health insurance and the WHO CVD Risk Assessment package for 12 months.
Health Insurance onlyBehavioural
Arm#2 (Control group): Provided Ghana's National Health Insurance for 12 months, brief behavioral counseling at baseline, and usual care.
| Study group | Role | What they receive |
|---|---|---|
| WHO CVD Risk Assessment package | Active comparator | Arm#1 (Intervention Group): Provided Ghana's National Health Insurance and the WHO CVD Risk Assessment package for 12 months. Receives: Behavioral: WHO CVD risk assessment package |
| Health Insurance only | Sham comparator | Arm#2 (Control group): Provided Ghana's National Health Insurance for 12 months, brief behavioral counseling at baseline,and usual care. Receives: Behavioral: Health Insurance only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in systolic Blood Pressure (BP)
BP control is defined as BP<140/90
Measured: Baseline to 12 months
Secondary outcomes (1)
Physical activity levels,change in weight,dietary intake of fruits and vegetables
Measured: 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study start1 May 2012
- Primary completion1 Oct 2016
- Study completion1 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 757 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Gbenga Ogedegbe, MD, MS, MPH, Principal investigator, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01802372
- Sponsor's protocol ID
- 12-01631
- Other IDs
- 1U01HL114198-01
- Acronym
- TASSH
- Status last verified
- May 2017
- First submitted
- 27 Feb 2013
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31996195Ogedegbe 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.
PubMed 29715303Gyamfi 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.
PubMed 28148255Ogedegbe 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.
PubMed 24923300
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Task Shifting and Blood Pressure Control in Ghana: A Cluster-Randomized Trial
- ClinicalTrials.gov ID
- NCT01802372
- Acronym / sponsor ID
- TASSH / 12-01631
- Conditions
- Hypertension, High Blood Pressure, Cardiovascular Diseases
- Keywords
- Hypertension, High Blood Pressure, Cardiovascular Diseases, Health Insurance Coverage, Low income countries, Ghana, Low resource settings, Comparative Effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 757 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 May 2012 (actual)
- Primary completion
- 1 Oct 2016 (actual)
- Study completion
- 1 Oct 2016 (actual)
- First posted
- 1 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WHO CVD Risk Assessment package | Active comparator | Behavioral: WHO CVD risk assessment packageArm#1 (Intervention Group): Provided Ghana's National Health Insurance and the WHO CVD Risk Assessment package for 12 months. |
| Health Insurance only | Sham comparator | Behavioral: Health Insurance onlyArm#2 (Control group): Provided Ghana's National Health Insurance for 12 months, brief behavioral counseling at baseline,and usual care. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- -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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WHO CVD risk assessment packageArm#1 (Intervention Group): Provided Ghana's National Health insurance and the WHO CVD Risk Assessment package for 12 months. | Behavioural | WHO CVD Risk Assessment package |
| Health Insurance onlyArm#2 (Control group): Provided Ghana's National Health Insurance for 12 months, brief behavioral counseling at baseline, and usual care. | Behavioural | Health Insurance only |
Primary outcome
Mean change in systolic Blood Pressure (BP)
Time frame: Baseline to 12 months
BP control is defined as BP<140/90
1 secondary outcome
Physical activity levels,change in weight,dietary intake of fruits and vegetables
Time frame: 12 months and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
- Derived from this study: PubMed 31996195Gyamfi 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.
- Derived from this study: PubMed 29715303Ogedegbe 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.
- Derived from this study: PubMed 28148255Gyamfi 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.
- Derived from this study: PubMed 24923300Ogedegbe 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gbenga Ogedegbe, MD, MS, MPH principal investigator
NYU Langone Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WHO CVD risk assessment package and Health Insurance only in people with Hypertension and High Blood Pressure, run by NYU Langone Health at 1 site in Ghana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in systolic Blood Pressure (BP) (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01802372, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2017.