Effectiveness of a Community Health Worker Delivered Care Intervention for Hypertension Control in Uganda (CHW-HTC)

• ClinicalTrials.gov Identifier: NCT05068505
• Recruitment Status: Completed
• First Posted: October 6, 2021
• Last Update Posted: February 29, 2024
• Sponsor: Charite University, Berlin, Germany
• Collaborators: 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
• Information provided by (Responsible Party): Prof. Dr. med. Felix Knauf, Charite University, Berlin, Germany

Tracking Information

• First Submitted Date: September 15, 2021
• First Posted Date: October 6, 2021
• Last Update Posted Date: February 29, 2024
• Actual Study Start Date: January 5, 2023
• Actual Primary Completion Date: February 1, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 24, 2021)

Blood pressure control [ Time Frame: 3 months ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 24, 2021)

• Glycemic control [ Time Frame: 3 months ]
  Defined as a reduction >1% in heamoglobin A1C
• Proportion of participants with blood pressure control [ Time Frame: 3 months ]
  Defined as blood pressure <140/90 mmHg

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: September 24, 2021)

Composite negative clinical cardiovascular disease (CVD) outcomes [ Time Frame: 3 months ]

Including CVD related admissions, stroke, and myocardial infarction, incident heart failure will be assessed.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Masking Description:

Participant Recruiters

Primary Purpose: Health Services Research

• Condition: Hypertension; Community Health Workers

Intervention

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 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

Study Arms

• 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 three clusters per month.
  Intervention: Behavioral: Community health worker delivered multicomponent intervention
• No Intervention: Control
  All clusters will be observed under both the intervention and control arm through sequential crossover.

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 24, 2021): 869
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: February 28, 2024
• Actual Primary Completion Date: February 1, 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Uganda

Administrative Information

• NCT Number: NCT05068505
• Other Study ID Numbers: Balamu2021
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Prof. Dr. med. Felix Knauf, Charite University, Berlin, Germany
• Original Responsible Party: Same as current
• Current Study Sponsor: Charite University, Berlin, Germany
• Original Study Sponsor: Same as current

Collaborators

• 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

• PRS Account: Charite University, Berlin, Germany
• Verification Date: February 2024