HypertensionNCT03490695
Uptake of Task-Strengthening for Blood Pressure Control
A study testing Practice Facilitation in people with Hypertension and High Blood Pressure, run by Kintampo Health Research Centre, Ghana at 1 site in Ghana.
Trial summary
Uptake of a community-based evidence-supported interventions for hypertension control in Ghana are urgently needed to address the cardiovascular disease epidemic and resulting illness, deaths, and societal costs. 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?
- Practice Facilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteGhana
- Study dates
- 14 Nov 2019to 30 Jun 2023
- 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
- Patients registered to receive care at CHPS zone
- Adults age 40 years and older
- Have BP 140-179/90-100 mm Hg
- Able to provide informed consent
Who cannot join
- Previous diagnosis of diabetes, stroke, heart failure or chronic kidney disease BP>180/100 mm Hg
- Positive urine dipstick for protein
- Pregnant
- Unable to provide informed consent
- Patients with history of stroke, heart failure, diabetes, angina, claudication, and BP>180/100 mm Hg will be referred to a specialist
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Uptake of Task-Strengthening Strategy for Hypertension Control Within Community Health Planning Services in Ghana: A Mixed Method Study.
Uptake of a community-based evidence-supported interventions for hypertension control in Ghana are urgently needed to address the cardiovascular disease epidemic and resulting illness, deaths, and societal costs. This study will evaluate the effect of Practice Facilitation on the uptake and maintenance of the evidence-based task-shifting strategies for hypertension control (TASSH) protocol across 70 Community-based Health Planning and Services (CHPS) zones delivered by trained community health officers.
Findings from this study will provide policy makers and other stakeholders the "how to do it" empirical literature on the uptake of evidence-based interventions in Ghana, which may be applicable to other low-income countries.
Read the detailed description
Ghana and other countries in sub-Saharan Africa (SSA) are experiencing an epidemic of cardiovascular diseases (CVD) propelled by rapidly increasing rates of hypertension requiring implementation of evidence-based interventions. However, persistent barriers to the uptake of evidence-based interventions in low resource settings including Ghana exist at the systems, organizational and provider levels. At the systems level, lack of leadership support and shortage of staff limit effective uptake of evidence-based hypertension interventions. At the organizational level, the organizational culture, particularly the organization's readiness or openness to change may influence the use of evidence-based hypertension interventions. At the provider-level, implementation climate, lack of training, the culture of individual practices, and provider's knowledge, self-efficacy and attitude towards the evidence-based intervention limits uptake and sustainability of evidence-based interventions. The ubiquity of CHPS zones in Ghana, and their growing involvement with implementing healthcare in every community, with outreach to every doorstep, presents a unique opportunity to evaluate the effectiveness and impact of scaling up evidence-based task-shifting strategies for hypertension (TASSH) control for adults in community settings. Using a mixed methods (quantitative-qualitative) design, the investigators will evaluate practice facilitation (PF) in 70 CHPS compounds utilizing the TASSH program.
The specific aims are as follows: (1) to identify practice capacity for the adoption of TASSH at CHPS compounds and develop a culturally tailored PF strategy using qualitative methods; (2a) Evaluate in a stepped-wedge cluster Randomized Controlled trial (RCT), the effect of the PF strategy vs. Usual Care (UC), on the uptake of TASSH (primary outcome) across the CHPS compounds at 12 months;(2b) Compare in a stepped-wedge cluster RCT, the clinical effectiveness of the PF strategy vs. UC on systolic BP reduction (secondary outcome) among adults with uncontrolled hypertension at 12 months; (3) Evaluate the mediators of the uptake of TASSH across the CHPS zones at 12 months; and (4) Evaluate the sustainability of TASSH implementation across the participating CHPS compounds at 24 months (one year after completion of the trial). Outcomes will be measured every 12 months in all clusters. Guided by Damshroeder's Consolidated Framework for Implementation Research (CFIR) and Glasgow's Reach Effectiveness Adoption Implementation and Maintenance (RE-AIM) framework, the goal of this project is to improve the uptake of evidence-based task-shifting strategies for hypertension control (TASSH) in CHPS zones in Ghana. This proposal is a collaboration between the Kwame Nkrumah University of Science and Technology, Kintampo Health Research Center, New York University (NYU) School of Medicine and Saint Louis University.
- Conditions
- Hypertension, High Blood Pressure, Cardiovascular Diseases
- Being tested
- Practice Facilitation, Usual Care
- 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.
Practice FacilitationOther
Community health nurses trained in implementing the evidence-based TASSH protocol will be employed as Practice Outreach Facilitators (POF) to train the CHPS community health officers to deliver TASSH. The POFs will be required to complete an intensive 12-week training course focused on adoption of TASSH protocol to identify patients at risk for uncontrolled HTN, initiate behavioral lifestyle counseling, and Refer patients to the community health centers for drug therapy. Over the course of 12 months, the POFs will provide support to their assigned CHPS zones to implement TASSH as part of routine patient care.The POFs will also work with CHPS directors to review current work flow and develop a plan of action for TASSH uptake at the CHPS zones.
Usual CareOther
Provide Ghana's National Health Insurance, behavioral counseling and referral for care through the usual care system for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Practice Facilitation Group A | Experimental | After the first 12 months of usual care (No Practice Facilitation), group A will begin to receive the Practice Facilitation (PF) Strategy at the CHPS compounds in addition to Ghana's National Health insurance and the World Health Organization (WHO) CVD Risk Assessment package. Receives: Other: Practice Facilitation; Other: Usual Care |
| Practice Facilitation Group B | Experimental | Group B will receive Usual Care (no PF) between 12-24 months which includes Ghana's National Health Insurance, behavioral counseling and referral to care through the usual care system.
After 24 months into the trial, Group B will then receive Practice Facilitation strategy in addition to Ghana's National Health insurance and the World Health Organization (WHO) CVD Risk Assessment package for a duration of another 12 months, as this is a stepped wedge design.
During this 12 months period, practice facilitation will end in the Group A arm. Receives: Other: Practice Facilitation; Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of adoption of TASSH at the CHPS zones at 12-months
This is a composite measure of adoption ratings to assess the degree to which the three essential elements of the TASSH protocol (identification and screening of patients for hypertension; proportion of patients who received lifestyle counseling by the Community Health Officers (CHOs); and proportion of hypertension (HTN) patients referred for initiation of drug treatment at the CHPS zones) are adopted
Measured: 12 months
Secondary outcomes (3)
Systolic BP reduction at 12 months (pre- and post-intervention)
Change in systolic BP from baseline to 12 months
Measured: 12 months
Mediators of TASSH uptake at CHPS zones at 12 months
Systems,organizational, and provider-level variables influencing TASSH uptake
Measured: 12 months
TASSH sustainability across the participating CHPS zones one year after PF intervention ends as measured by the maintenance of TASSH adoption ratings
Maintenance of PF intervention effects one year after trial completion evident through sustained adoption ratings
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start14 Nov 2019
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- For the first 12-month of the study, the intervention will not be implemented as this is a stepped-wedged design. During this time period, primary outcome (adoption ratings) and secondary outcome (Systolic BP) data will be collected at the CHPS Zones following TASSH training and the PFOs will provide support to their assigned CHPS zones to prepare to implement the TASSH protocol. Each CHPS zones will then be randomly assigned to one of the two intervention arms: Group A will receive the Practice Facilitation Strategy at 12 months and Group B will initially serve as a Usual Care comparison group. Group B will then receive Practice Facilitation beginning 24 months into the trial, as this is a stepped wedge design. Sustainability for groups A and B will be assessed one year after the end of the intervention.
- Masking
- None (open label)
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kintampo Health Research Centre, Ghana
- Sponsor type
- University, hospital or other
- Collaborators
- NYU Langone Health, Kwame Nkrumah University of Science and Technology, St. Louis University, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Kwaku Poku Asante, Kintampo Health Research Centre, Ghana
- Investigators
- Gbenga Ogedegbe, MD, Principal investigator, NYU Langone HealthKwaku Poku Asante, PhD, Principal investigator, Kintampo Health Research Centre, GhanaJuliet Iwelunmor, PhD, Principal investigator, St. Louis UniversityJacob Plange-Rhule, MD, Principal investigator, Kwame Nkrumah University of Science and TechnologyKweku Bedu-Addo, PhD, Principal investigator, Kwame Nkrumah University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490695
- Sponsor's protocol ID
- 7U01HL138638-04
- Other IDs
- 7U01HL138638-04
- Status last verified
- Jul 2022
- First submitted
- 30 Jan 2018
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Aggregate deidentified data will be shared with other researchers
Publications
Asante KP, Iwelunmor J, Apusiga K, Gyamfi J, Nyame S, Adjei KGA, Aifah A, Adjei K, Onakomaiya D, Chaplin WF, Ogedegbe G, Plange-Rhule J. Uptake of Task-Strengthening Strategy for Hypertension (TASSH) control within Community-Based Health Planning Services in Ghana: study protocol for a cluster randomized controlled trial. Trials. 2020 Oct 2;21(1):825. doi: 10.1186/s13063-020-04667-7.
PubMed 33008455
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uptake of Task-Strengthening Strategy for Hypertension Control Within Community Health Planning Services in Ghana: A Mixed Method Study.
- ClinicalTrials.gov ID
- NCT03490695
- Acronym / sponsor ID
- 7U01HL138638-04
- Conditions
- Hypertension, High Blood Pressure, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Kintampo Health Research Centre, GhanaUniversity, hospital or other
- Collaborators
- NYU Langone Health, Kwame Nkrumah University of Science and Technology, St. Louis University, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 14 Nov 2019 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 6 Apr 2018 (actual)
- 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.
Uptake of a community-based evidence-supported interventions for hypertension control in Ghana are urgently needed to address the cardiovascular disease epidemic and resulting illness, deaths, and societal costs. This study will evaluate the effect of Practice Facilitation on the uptake and maintenance of the evidence-based task-shifting strategies for hypertension control (TASSH) protocol across 70 Community-based Health Planning and Services (CHPS) zones delivered by trained community health officers.
Findings from this study will provide policy makers and other stakeholders the "how to do it" empirical literature on the uptake of evidence-based interventions in Ghana, which may be applicable to other low-income countries.
Detailed description
Ghana and other countries in sub-Saharan Africa (SSA) are experiencing an epidemic of cardiovascular diseases (CVD) propelled by rapidly increasing rates of hypertension requiring implementation of evidence-based interventions. However, persistent barriers to the uptake of evidence-based interventions in low resource settings including Ghana exist at the systems, organizational and provider levels. At the systems level, lack of leadership support and shortage of staff limit effective uptake of evidence-based hypertension interventions. At the organizational level, the organizational culture, particularly the organization's readiness or openness to change may influence the use of evidence-based hypertension interventions. At the provider-level, implementation climate, lack of training, the culture of individual practices, and provider's knowledge, self-efficacy and attitude towards the evidence-based intervention limits uptake and sustainability of evidence-based interventions. The ubiquity of CHPS zones in Ghana, and their growing involvement with implementing healthcare in every community, with outreach to every doorstep, presents a unique opportunity to evaluate the effectiveness and impact of scaling up evidence-based task-shifting strategies for hypertension (TASSH) control for adults in community settings. Using a mixed methods (quantitative-qualitative) design, the investigators will evaluate practice facilitation (PF) in 70 CHPS compounds utilizing the TASSH program.
The specific aims are as follows: (1) to identify practice capacity for the adoption of TASSH at CHPS compounds and develop a culturally tailored PF strategy using qualitative methods; (2a) Evaluate in a stepped-wedge cluster Randomized Controlled trial (RCT), the effect of the PF strategy vs. Usual Care (UC), on the uptake of TASSH (primary outcome) across the CHPS compounds at 12 months;(2b) Compare in a stepped-wedge cluster RCT, the clinical effectiveness of the PF strategy vs. UC on systolic BP reduction (secondary outcome) among adults with uncontrolled hypertension at 12 months; (3) Evaluate the mediators of the uptake of TASSH across the CHPS zones at 12 months; and (4) Evaluate the sustainability of TASSH implementation across the participating CHPS compounds at 24 months (one year after completion of the trial). Outcomes will be measured every 12 months in all clusters. Guided by Damshroeder's Consolidated Framework for Implementation Research (CFIR) and Glasgow's Reach Effectiveness Adoption Implementation and Maintenance (RE-AIM) framework, the goal of this project is to improve the uptake of evidence-based task-shifting strategies for hypertension control (TASSH) in CHPS zones in Ghana. This proposal is a collaboration between the Kwame Nkrumah University of Science and Technology, Kintampo Health Research Center, New York University (NYU) School of Medicine and Saint Louis University.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- For the first 12-month of the study, the intervention will not be implemented as this is a stepped-wedged design. During this time period, primary outcome (adoption ratings) and secondary outcome (Systolic BP) data will be collected at the CHPS Zones following TASSH training and the PFOs will provide support to their assigned CHPS zones to prepare to implement the TASSH protocol. Each CHPS zones will then be randomly assigned to one of the two intervention arms: Group A will receive the Practice Facilitation Strategy at 12 months and Group B will initially serve as a Usual Care comparison group. Group B will then receive Practice Facilitation beginning 24 months into the trial, as this is a stepped wedge design. Sustainability for groups A and B will be assessed one year after the end of the intervention.
| Arm | Type | Receives |
|---|---|---|
| Practice Facilitation Group A | Experimental | Other: Practice Facilitation, Other: Usual CareAfter the first 12 months of usual care (No Practice Facilitation), group A will begin to receive the Practice Facilitation (PF) Strategy at the CHPS compounds in addition to Ghana's National Health insurance and the World Health Organization (WHO) CVD Risk Assessment package. |
| Practice Facilitation Group B | Experimental | Other: Practice Facilitation, Other: Usual CareGroup B will receive Usual Care (no PF) between 12-24 months which includes Ghana's National Health Insurance, behavioral counseling and referral to care through the usual care system. After 24 months into the trial, Group B will then receive Practice Facilitation strategy in addition to Ghana's National Health insurance and the World Health Organization (WHO) CVD Risk Assessment package for a duration of another 12 months, as this is a stepped wedge design. During this 12 months period, practice facilitation will end in the Group A arm. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients registered to receive care at CHPS zone
- Adults age 40 years and older
- Have BP 140-179/90-100 mm Hg
- Able to provide informed consent
Key exclusion criteria (5 listed)
- Previous diagnosis of diabetes, stroke, heart failure or chronic kidney disease BP>180/100 mm Hg
- Positive urine dipstick for protein
- Pregnant
- Unable to provide informed consent
- Patients with history of stroke, heart failure, diabetes, angina, claudication, and BP>180/100 mm Hg will be referred to a specialist
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 |
|---|---|---|
| Practice FacilitationCommunity health nurses trained in implementing the evidence-based TASSH protocol will be employed as Practice Outreach Facilitators (POF) to train the CHPS community health officers to deliver TASSH. The POFs will be required to complete an intensive 12-week training course focused on adoption of TASSH protocol to identify patients at risk for uncontrolled HTN, initiate behavioral lifestyle counseling, and Refer patients to the community health centers for drug therapy. Over the course of 12 months, the POFs will provide support to their assigned CHPS zones to implement TASSH as part of routine patient care.The POFs will also work with CHPS directors to review current work flow and develop a plan of action for TASSH uptake at the CHPS zones. | Other | Practice Facilitation Group A, Practice Facilitation Group B |
| Usual CareProvide Ghana's National Health Insurance, behavioral counseling and referral for care through the usual care system for 12 months. | Other | Practice Facilitation Group A, Practice Facilitation Group B |
Primary outcome
Rate of adoption of TASSH at the CHPS zones at 12-months
Time frame: 12 months
This is a composite measure of adoption ratings to assess the degree to which the three essential elements of the TASSH protocol (identification and screening of patients for hypertension; proportion of patients who received lifestyle counseling by the Community Health Officers (CHOs); and proportion of hypertension (HTN) patients referred for initiation of drug treatment at the CHPS zones) are adopted
3 secondary outcomes
Systolic BP reduction at 12 months (pre- and post-intervention)
Time frame: 12 months
Mediators of TASSH uptake at CHPS zones at 12 months
Time frame: 12 months
TASSH sustainability across the participating CHPS zones one year after PF intervention ends as measured by the maintenance of TASSH adoption ratings
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- Derived from this study: PubMed 33008455Asante KP, Iwelunmor J, Apusiga K, Gyamfi J, Nyame S, Adjei KGA, Aifah A, Adjei K, Onakomaiya D, Chaplin WF, Ogedegbe G, Plange-Rhule J. Uptake of Task-Strengthening Strategy for Hypertension (TASSH) control within Community-Based Health Planning Services in Ghana: study protocol for a cluster randomized controlled trial. Trials. 2020 Oct 2;21(1):825. doi: 10.1186/s13063-020-04667-7.
- Individual participant dataSharing planned: No. Aggregate deidentified data will be shared with other researchers
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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 principal investigator
NYU Langone Health
Kwaku Poku Asante, PhD principal investigator
Kintampo Health Research Centre, Ghana
Juliet Iwelunmor, PhD principal investigator
St. Louis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Practice Facilitation in people with Hypertension and High Blood Pressure, run by Kintampo Health Research Centre, Ghana 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 Aug 2022. 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. 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?
Results are not available in the source record.
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?
Rate of adoption of TASSH at the CHPS zones at 12-months (time frame: 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 NCT03490695, which also lists 1 linked publication.
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 1 Aug 2022.