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临床试验/NCT05068505
NCT05068505已完成不适用

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

Charite University, Berlin, Germany1 个研究点 分布在 1 个国家目标入组 869 人开始时间: 2023年1月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
869
试验地点
1
主要终点
Blood pressure control

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

Participant Recruiters

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Patients diagnosed with hypertension but already controlled
  • Pregnant women
  • Patients with an expected life expectancy of less than one year

结局指标

主要结局

Blood pressure control

时间窗: 3 months

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

次要结局

  • Proportion of participants with blood pressure control(3 months)
  • Glycemic control(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. med. Felix Knauf

Director of the Charité Mitte Campus - Senior Physician

Charite University, Berlin, Germany

研究点 (1)

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