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

NCT05068505 | Completed DMC

• 1 other identifier: Balamu2021
• Study Type: interventional
• Target: 869
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Community Health Workers

Keywords

Hypertension; Community health workers; Uncontrolled blood pressure; Uganda

Outcome Measures

Primary Outcomes (1)

• Blood pressure control

  Decrease in the average systolic and/or diastolic blood pressure between the intervention and control arms.

  3 months

Secondary Outcomes (2)

• Glycemic control

  3 months

• Proportion of participants with blood pressure control

  3 months

Other Outcomes (1)

• Composite negative clinical cardiovascular disease (CVD) outcomes

  3 months

Study Arms (2)

Community health worker delivered multicomponent intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

All clusters will be observed under both the intervention and control arm through sequential crossover.

Interventions

Community health worker delivered multicomponent intervention BEHAVIORAL

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

Community health worker delivered multicomponent intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients diagnosed with hypertension but already controlled
• Pregnant women
• Patients with an expected life expectancy of less than one year

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• University of Miami: collaborator
• Makerere University: collaborator
• Yale University: collaborator
• London School of Hygiene and Tropical Medicine: collaborator
• Johns Hopkins University: collaborator
• Ministry of Health, Uganda: collaborator
• African Community Center for Social Sustainability: collaborator

Study Sites (1)

Makerere University College of Health Sciences

Kampala, Uganda

Location

Related Publications (1)

• Ingenhoff R, Nandawula J, Siddharthan T, Ssekitoleko I, Munana R, Bodnar BE, Weswa I, Kirenga BJ, Mutungi G, van der Giet M, Kalyesubula R, Knauf F. Effectiveness of a community health worker-delivered care intervention for hypertension control in Uganda: study protocol for a stepped wedge, cluster randomized control trial. Trials. 2022 May 24;23(1):440. doi: 10.1186/s13063-022-06403-9.

  PMID: 35610712 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Felix Knauf, Prof.Dr.med.

  Charité University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participant Recruiters
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Charité Mitte Campus - Senior Physician

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: October 6, 2021
• Study Start: January 5, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 28, 2024
• Last Updated: February 29, 2024

Record last verified: 2024-02

Locations

UG (1)