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Uptake of Task-Strengthening for Blood Pressure Control

Primary Purpose

Hypertension, High Blood Pressure, Cardiovascular Diseases

Status
Active
Phase
Not Applicable
Locations
Ghana
Study Type
Interventional
Intervention
Practice Facilitation
Usual Care
Sponsored by
Kintampo Health Research Centre, Ghana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Sites / Locations

  • Kintampo Health Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Practice Facilitation Group A

Practice Facilitation Group B

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Systolic BP reduction at 12 months (pre- and post-intervention)
Change in systolic BP from baseline to 12 months
Mediators of TASSH uptake at CHPS zones at 12 months
Systems,organizational, and provider-level variables influencing TASSH uptake
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

Full Information

First Posted
January 30, 2018
Last Updated
July 29, 2022
Sponsor
Kintampo Health Research Centre, Ghana
Collaborators
NYU Langone Health, Kwame Nkrumah University of Science and Technology, St. Louis University, National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT03490695
Brief Title
Uptake of Task-Strengthening for Blood Pressure Control
Official Title
Uptake of Task-Strengthening Strategy for Hypertension Control Within Community Health Planning Services in Ghana: A Mixed Method Study.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 14, 2019 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kintampo Health Research Centre, Ghana
Collaborators
NYU Langone Health, Kwame Nkrumah University of Science and Technology, St. Louis University, National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, High Blood Pressure, Cardiovascular Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
700 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Practice Facilitation Group A
Arm Type
Experimental
Arm Description
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.
Arm Title
Practice Facilitation Group B
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Practice Facilitation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Provide Ghana's National Health Insurance, behavioral counseling and referral for care through the usual care system for 12 months.
Primary Outcome Measure Information:
Title
Rate of adoption of TASSH at the CHPS zones at 12-months
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Systolic BP reduction at 12 months (pre- and post-intervention)
Description
Change in systolic BP from baseline to 12 months
Time Frame
12 months
Title
Mediators of TASSH uptake at CHPS zones at 12 months
Description
Systems,organizational, and provider-level variables influencing TASSH uptake
Time Frame
12 months
Title
TASSH sustainability across the participating CHPS zones one year after PF intervention ends as measured by the maintenance of TASSH adoption ratings
Description
Maintenance of PF intervention effects one year after trial completion evident through sustained adoption ratings
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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 Exclusion Criteria 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gbenga Ogedegbe, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kwaku Poku Asante, PhD
Organizational Affiliation
Kintampo Health Research Centre, Ghana
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Juliet Iwelunmor, PhD
Organizational Affiliation
St. Louis University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jacob Plange-Rhule, MD
Organizational Affiliation
Kwame Nkrumah University of Science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kweku Bedu-Addo, PhD
Organizational Affiliation
Kwame Nkrumah University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kintampo Health Research Centre
City
Kintampo
Country
Ghana

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Aggregate deidentified data will be shared with other researchers
Citations:
PubMed Identifier
33008455
Citation
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.
Results Reference
derived

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Uptake of Task-Strengthening for Blood Pressure Control

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