Clinical trial NCT05068505: Effectiveness of a Community Health Worker Delivered Care Intervention for Hypertension Control in Uganda
Official title: Effectiveness of a Community Health Worker Delivered Care Intervention for Hypertension Control in Uganda: a Stepped Wedge, Cluster Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension; Community Health Workers
Keywords: Hypertension
Community health workers
Uncontrolled blood pressure
Uganda
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: University of Miami
name: Makerere University
name: Yale University
name: London School of Hygiene and Tropical Medicine
name: Johns Hopkins University
name: Ministry of Health, Uganda
name: African Community Center for Social Sustainability
First posted: 2021-10-06
Enrollment: 869
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Blood pressure control
timeFrame: 3 months
Secondary outcomes:
measure: Glycemic control
timeFrame: 3 months
measure: Proportion of participants with blood pressure control
timeFrame: 3 months
Other outcomes:
measure: Composite negative clinical cardiovascular disease (CVD) outcomes
timeFrame: 3 months
Locations:
city: Kampala
country: Uganda
facility: Makerere University College of Health Sciences
Study officials:
affiliation: Charité University, Berlin, Germany
name: Felix Knauf, Prof.Dr.med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.