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

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ClinicalTrials.gov Identifier: NCT05068505
Recruitment Status : Completed
First Posted : October 6, 2021
Last Update Posted : February 29, 2024
Sponsor:
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

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.

Condition or disease Intervention/treatment Phase
Hypertension; Community Health Workers Behavioral: Community health worker delivered multicomponent intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 869 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Participant Recruiters
Primary Purpose: Health Services Research
Official Title: Effectiveness of a Community Health Worker Delivered Care Intervention for Hypertension Control in Uganda: a Stepped Wedge, Cluster Randomized Control Trial
Actual Study Start Date : January 5, 2023
Actual Primary Completion Date : February 1, 2024
Actual Study Completion Date : February 28, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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


No Intervention: Control
All clusters will be observed under both the intervention and control arm through sequential crossover.



Primary Outcome Measures :
  1. Blood pressure control [ Time Frame: 3 months ]
    Decrease in the average systolic and/or diastolic blood pressure between the intervention and control arms.


Secondary Outcome Measures :
  1. Glycemic control [ Time Frame: 3 months ]
    Defined as a reduction >1% in heamoglobin A1C

  2. Proportion of participants with blood pressure control [ Time Frame: 3 months ]
    Defined as blood pressure <140/90 mmHg


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05068505


Locations
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Uganda
Makerere University College of Health Sciences
Kampala, Uganda
Sponsors and Collaborators
Charite University, Berlin, Germany
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
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Principal Investigator: Felix Knauf, Prof.Dr.med. Charité University, Berlin, Germany
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Dr. med. Felix Knauf, Director of the Charité Mitte Campus - Senior Physician, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT05068505    
Other Study ID Numbers: Balamu2021
First Posted: October 6, 2021    Key Record Dates
Last Update Posted: February 29, 2024
Last Verified: February 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dr. med. Felix Knauf, Charite University, Berlin, Germany:
Hypertension
Community health workers
Uncontrolled blood pressure
Uganda
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases