Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03490695 |
| Other study ID # |
7U01HL138638-04 |
| Secondary ID |
7U01HL138638-04 |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 14, 2019 |
| Est. completion date |
June 30, 2023 |
Study information
| Verified date |
July 2022 |
| Source |
Kintampo Health Research Centre, Ghana |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
