Makerere University College of Health Sciences
Kampala, Uganda
NCT Number: NCT05068505
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 seven months, 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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Kampala, Uganda
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The multi-component intervention will be centered on monthly household visits by trained CHWs for a period of seven months in a rural setting in Nakaseke, Uganda, 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. We will measure blood pressure at baseline and 3-monthly for the entire cohort. We will conduct individual-level mixed effects analyses of study data, adjusting for time and clustering by patient and community.
We will conduct an interim analysis at 3 months to assess differences between groups. If a statistically significant difference is detected the intervention will be applied across the remaining clusters
Time frame: 3 months
Decrease in the average systolic and/or diastolic blood pressure between the intervention and control arms.
Time frame: 3 months
Defined as a reduction >1% in heamoglobin A1C
Time frame: 3 months
Defined as blood pressure <140/90 mmHg
Time frame: 3 months
Including CVD related admissions, stroke, and myocardial infarction, incident heart failure will be assessed.
Charite University, Berlin, Germany
Other
Effectiveness of a Community Health Worker Delivered Care Intervention for Hypertension Control in Uganda: a Stepped Wedge, Cluster Randomized Control Trial
Acronym: CHW-HTC
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