Effectiveness of a Community Health Worker Delivered Care Intervention for Hypertension Control in Uganda

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of a Community Health Worker Delivered Care Intervention for Hypertension Control in Uganda: a Stepped Wedge, Cluster Randomized Control Trial

Conditions
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Hypertension; Community Health Workers

Intervention / Treatment
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* Behavioral: Community health worker delivered multicomponent intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with hypertension (Systolic >140 and/or Diastolic >90) Participants attending the two NCD clinics Adults 18 years and above Participants residing in the three sub counties (Nakaseke Town Council, Nakaseke Sub County and Kasangombe of Nakaseke district) Participants able to give informed consent. Exclusion Criteria: Patients diagnosed with hypertension but already controlled Pregnant women Patients with an expected life expectancy of less than one year

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Community health worker delivered multicomponent intervention<br>The study will employ a closed cohort stepped wedge cluster randomized design. There will be a sequential crossover of clusters from the control to the intervention arms and the order of the cross over will be randomly determined. This study will be conducted in 21 clusters within Nakaseke district. Each cluster will consist of 4-5 villages. We plan to rollout the intervention in three clusters per month. | Behavioral: Community health worker delivered multicomponent intervention<br>* 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<br>|
| No Intervention: Control<br>All clusters will be observed under both the intervention and control arm through sequential crossover. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure control | Decrease in the average systolic and/or diastolic blood pressure between the intervention and control arms. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control | Defined as a reduction >1% in heamoglobin A1C | 3 months | 
| Proportion of participants with blood pressure control | Defined as blood pressure <140/90 mmHg | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uganda, Hypertension, Community health workers, Uncontrolled blood pressure