CHW-HTC: Effectiveness of a Community Health Worker Delivered Care Intervention for Hypertension Control in Uganda
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Community health worker delivered multicomponent intervention 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 two clusters per month and one cluster in the final month. |
Behavioral: Community health worker delivered multicomponent intervention
The multi-component intervention will be centered on monthly household visits by trained CHWs for a period of one year 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 12 months to assess differences between groups. If a statistically significant difference is detected the intervention will be applied across the remaining clusters
|
| No Intervention: Control All clusters will be observed under both the intervention and control arm through sequential crossover. |
Outcome Measures
Primary Outcome Measures
- Blood pressure control [3 months]
Decrease in the average systolic and/or diastolic blood pressure between the intervention and control arms.
Secondary Outcome Measures
- Glycemic control [3 months]
Defined as a reduction >1% in heamoglobin A1C
- Proportion of participants with blood pressure control [3 months]
Defined as blood pressure <140/90 mmHg
Other Outcome Measures
- Composite negative clinical cardiovascular disease (CVD) outcomes [3 months]
Including CVD related admissions, stroke, and myocardial infarction, incident heart failure will be assessed.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Participants with hypertension (Systolic >140 and/or Diastolic >90)
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Participants attending the two NCD clinics
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Adults 18 years and above
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Participants residing in the three sub counties (Nakaseke Town Council, Nakaseke Sub County and Kasangombe of Nakaseke district)
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Participants able to give informed consent.
Exclusion Criteria:
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Patients diagnosed with hypertension but already controlled
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Pregnant women
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Patients with an expected life expectancy of less than one year
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Makerere University College of Health Sciences | Kampala | Uganda |
Sponsors and Collaborators
- Charite University, Berlin, Germany
- University of Miami
- Makerere University
- Yale University
- London School of Hygiene and Tropical Medicine
- Johns Hopkins University
- Ministry of Health, Uganda
- African Community Center for Social Sustainability
Investigators
- Principal Investigator: Felix Knauf, Prof.Dr.med., Charité University, Berlin, Germany
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Balamu2021