Hypertension; Community Health Workers
Conditions
Keywords
Hypertension, Community health workers, Uncontrolled blood pressure, Uganda
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 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.
Interventions
BEHAVIORALCommunity health worker delivered multicomponent intervention
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
Sponsors
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
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
Participant Recruiters
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure control | 3 months | Decrease in the average systolic and/or diastolic blood pressure between the intervention and control arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Composite negative clinical cardiovascular disease (CVD) outcomes | 3 months | Including CVD related admissions, stroke, and myocardial infarction, incident heart failure will be assessed. |
Countries
Uganda
Outcome results
None listed