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Completed

NCT Number: NCT05068505

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Makerere University College of Health Sciences

Kampala, Uganda

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

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

Registry information

Official study title

Effectiveness of a Community Health Worker Delivered Care Intervention for Hypertension Control in Uganda: a Stepped Wedge, Cluster Randomized Control Trial

Acronym: CHW-HTC

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 6, 2021
Registry last updated
Feb 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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