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

NCT ID: NCT05068505

Last Updated: 2024-02-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 869 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-05
• Study Completion Date: 2024-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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 three clusters per month.

Group Type: EXPERIMENTAL

Community health worker delivered multicomponent intervention

Intervention Type: 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

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Community 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: collaborator

Makerere University

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

Ministry of Health, Uganda

OTHER_GOV

Sponsor Role: collaborator

African Community Center for Social Sustainability

UNKNOWN

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. med. Felix Knauf

Director of the Charité Mitte Campus - Senior Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Felix Knauf, Prof.Dr.med.

Role: PRINCIPAL_INVESTIGATOR

Charité University, Berlin, Germany

Locations

Makerere University College of Health Sciences

Kampala, , Uganda

Countries

Uganda

References

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.

Reference Type: DERIVED

PMID: 35610712 (View on PubMed)

Other Identifiers

Balamu2021

Identifier Type: -

Identifier Source: org_study_id