TY - JOUR
T1 - Addressing Hypertension Care in Africa (ADHINCRA)
T2 - Study protocol for a cluster-randomized controlled pilot trial
AU - Commodore-Mensah, Yvonne
AU - Sarfo, Fred Stephen
AU - Turkson-Ocran, Ruth Alma
AU - Foti, Kathryn
AU - Mobula, Linda Meta
AU - Himmelfarb, Cheryl Dennison
AU - Carson, Kathryn A.
AU - Appiah, Lambert T.
AU - Degani, Michael
AU - Lang'at, Chemuttaai
AU - Nyamekye, Gideon
AU - Molello, Nancy E.
AU - Ahima, Rexford
AU - Cooper, Lisa A.
N1 - Funding Information:
We would like to thank the health system leaders, clinicians, community health nurses, research staff members, and other stakeholders whose support facilitated the research.
Publisher Copyright:
© 2022
PY - 2023/2
Y1 - 2023/2
N2 - Background: Uncontrolled hypertension is a major risk factor for cardiovascular disease. Evidence-based interventions to improve hypertension control in high-income countries have not been translated equally in sub-Saharan Africa (SSA). The objective of the Addressing Hypertension Care in Africa (ADHINCRA) Study was to test the feasibility and signal of efficacy of a multilevel, nurse-led, mobile health enhanced intervention in improving hypertension control in Ghana. Methods: Using a cluster randomized controlled pilot trial design, four hospitals in Kumasi, Ghana, were randomized to the intervention arm (2 hospitals) and enhanced usual care arm (2 hospitals). A total of 240 patients with uncontrolled hypertension defined as systolic blood pressure (BP) ≥140 mmHg on their most recent visit were included (60 patients per hospital). Patients in the intervention arm received an intervention that consisted of nurse-led task-shifting and a mobile health application (Medtronic® Labs' Empower Health), and home BP monitoring. The enhanced usual care arm received usual care as determined by their providers, plus short text messages on health. The intervention was administered for six months, after which it was withdrawn, and patients were followed for six more months to assess outcomes. Feasibility measures included recruitment and dropout rates of study participants, protocol adherence in both arms. Clinical outcomes included changes in BP control status and systolic BP levels from baseline. Secondary outcomes included change in glycemic control, rates of hypertensive urgencies/emergencies, cardiovascular disease events, and medication adherence. Discussion: Findings from this study will provide critical pilot data to inform the conduct of a larger scale trial and the development of scalable health system and policy interventions to improve hypertension control in low-resource settings. Trial registration NCT04010344. Registered on July 8, 2019 at ClinicalTrials.govhttps://clinicaltrials.gov/ct2/show/NCT04010344
AB - Background: Uncontrolled hypertension is a major risk factor for cardiovascular disease. Evidence-based interventions to improve hypertension control in high-income countries have not been translated equally in sub-Saharan Africa (SSA). The objective of the Addressing Hypertension Care in Africa (ADHINCRA) Study was to test the feasibility and signal of efficacy of a multilevel, nurse-led, mobile health enhanced intervention in improving hypertension control in Ghana. Methods: Using a cluster randomized controlled pilot trial design, four hospitals in Kumasi, Ghana, were randomized to the intervention arm (2 hospitals) and enhanced usual care arm (2 hospitals). A total of 240 patients with uncontrolled hypertension defined as systolic blood pressure (BP) ≥140 mmHg on their most recent visit were included (60 patients per hospital). Patients in the intervention arm received an intervention that consisted of nurse-led task-shifting and a mobile health application (Medtronic® Labs' Empower Health), and home BP monitoring. The enhanced usual care arm received usual care as determined by their providers, plus short text messages on health. The intervention was administered for six months, after which it was withdrawn, and patients were followed for six more months to assess outcomes. Feasibility measures included recruitment and dropout rates of study participants, protocol adherence in both arms. Clinical outcomes included changes in BP control status and systolic BP levels from baseline. Secondary outcomes included change in glycemic control, rates of hypertensive urgencies/emergencies, cardiovascular disease events, and medication adherence. Discussion: Findings from this study will provide critical pilot data to inform the conduct of a larger scale trial and the development of scalable health system and policy interventions to improve hypertension control in low-resource settings. Trial registration NCT04010344. Registered on July 8, 2019 at ClinicalTrials.govhttps://clinicaltrials.gov/ct2/show/NCT04010344
KW - Blood pressure control
KW - Ghana
KW - Hypertension
KW - Task sharing
KW - Task shifting
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U2 - 10.1016/j.cct.2022.107077
DO - 10.1016/j.cct.2022.107077
M3 - Article
C2 - 36592818
AN - SCOPUS:85146091859
SN - 1551-7144
VL - 125
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
M1 - 107077
ER -