What is the clinical evidence from this study?

Study design: RCT. Population: Hypertension (n=869). Intervention: Community health worker-led intervention vs. Usual care. Primary outcome: Decrease in the average systolic blood pressure.

May 24, 2022Open Access

Effectiveness of a community health worker-delivered care intervention for hypertension control in Uganda: study protocol for a stepped wedge, cluster randomized control trial

Key Result

A community health worker-led intervention for hypertension control in rural Uganda is being evaluated in a stepped-wedge cluster randomized trial, with no results reported yet.

Study Design

Type

RCT (n=869)

Blinding

Open-label

Randomization

Cluster randomized

Multicenter

Yes

Structured PICO

Does a community health worker-led home visit intervention reduce systolic blood pressure in adults with uncontrolled hypertension in rural Uganda?

Population

A planned stepped-wedge cluster randomized trial of 869 adults with uncontrolled hypertension in rural Uganda to evaluate a community health worker-led intervention over 1 year.

Intervention

Community health worker (CHW)-led multi-component intervention consisting of monthly pro-active household visits for 1 year. Includes blood pressure and blood sugar monitoring, BMI monitoring, cardiovascular disease risk assessment, healthy lifestyle counseling and education, follow-up reminders, and provision of PocketDoktor educational booklets.

Comparator

Usual care (monthly to 3-monthly patient visits to existing NCD clinics using WHO PEN tools, routine clinic activities including vital signs, group counseling, clinician review, and standard medication prescription).

Outcome

Decrease in the average systolic blood pressure between the intervention and control arms.surrogate

This study protocol outlines a stepped-wedge cluster randomized trial to evaluate whether a community health worker-led intervention can effectively lower systolic blood pressure among hypertensive patients in a resource-limited rural setting.

Limitations

Lack of blinding for investigators and participants due to the nature of the intervention
Risk of loss of confidentiality
Potential discomfort from measuring devices and finger stick glucose screening

Abstract

BACKGROUND: 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, particularly in sub-Saharan African settings. In Uganda, and the majority of LMICs, management of uncontrolled hypertension remains limited in constrained health systems. Intervening at the primary care level, using CHWs to improve medical treatment outcomes has not been well studied. We 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: We will conduct 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 1 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, and (5) healthy lifestyle counseling 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. CONCLUSION: The results of this study will inform community delivered HTN management across a range of LMIC settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT05068505 . Registered on October 6, 2021.

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