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Clinical Trial Summary

Over 80% of the morbidity and mortality related to non-communicable diseases (NCDs) occurs in low-income and middle-income countries (LMICs). Community health workers (CHWs) may improve disease control and medication adherence among patients with NCDs in LMICs, but data are scarce, particularly in sub-Saharan African settings. In Uganda, and the majority of LMICs, management of uncontrolled blood pressure remains limited in constrained health systems. Intervening at the primary care level, using CHWs to improve medical treatment outcomes has not been well studied. The investigators aim to determine the effectiveness of a CHW-led intervention in blood pressure control among confirmed hypertensive patients and patient-related factors associated with uncontrolled hypertension. Methods: Conduction of a stepped-wedge cluster randomized controlled trial study of 869 adult patients with hypertension attending two NCD clinics to test the effectiveness, acceptability and fidelity of a CHW-led intervention. The multi-component intervention will be centered on monthly household visits by trained CHWs for a period of one year, consisting of the following; (1) blood pressure and sugar monitoring; (2) BMI monitoring; (3) cardiovascular disease risk assessment; (4) Using checklists to guide monitoring and referral to clinics; (5) healthy lifestyle counselling and education. During home visits, CHWs will remind patients of follow-up visits. The investigators will measure blood pressure at baseline and 3-monthly for the entire cohort. The investigators will additionally test acceptability of the intervention and fidelity over the course of the intervention. The investigators will conduct individual-level mixed effects analyses of study data, adjusting for time and clustering by patient and community. Conclusion: The results of this study will inform community delivered hypertension management across a range of LMIC settings.


Clinical Trial Description

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Study Design


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NCT number NCT05068505
Study type Interventional
Source Charite University, Berlin, Germany
Contact Felix Knauf, Prof.Dr.med.
Phone +49 30 450 514466
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date November 1, 2021
Completion date February 1, 2023