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临床试验/NCT04158154
NCT04158154已完成不适用

Transforming Hypertension Treatment in Nigeria Using a Type II Hybrid, Interrupted Time Series Design

Washington University School of Medicine60 个研究点 分布在 1 个国家目标入组 21,922 人开始时间: 2020年2月1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
21,922
试验地点
60
主要终点
Change from Baseline Slope of Treatment Rate

研究概览

简要总结

The purpose of the Transforming Hypertension Treatment in Nigeria Program is to improve awareness, treatment, and control of hypertension in Nigeria through the adaptation, implementation, and evaluation of the effectiveness and implementation of a system-level hypertension control program.

详细描述

This study includes the implementation and evaluation of a culturally- and contextually-adapted intervention package based on the Kaiser Permanente Northern California and World Health Organization HEARTS programs for hypertension diagnosis and treatment at primary health centers in Abuja, Nigeria. The intervention has been adapted based on a local needs' assessment including evidence synthesis and specific exploration of health care workers' knowledge, attitudes, and behaviors related to hypertension, causes, consequences, and treatment, including fixed-dose combination and patient self-management, and patients' knowledge, attitudes, and behaviors related to hypertension, causes, consequences, and treatment. Implementation pathways have been developed with particular attention to overcoming modifiable system- and patient-level barriers to hypertension treatment and control across capability, intentional, and system domains using the Consolidated Framework for Implementation Research. Preparedness and capacity have been assessed at primary health centers (e.g. available staff; information systems; use of clinical guidelines) through an adapted Service Availability and Readiness Assessment (SARA) instrument during the formative work for this study. The multi-level implementation package includes: 1) patient registration and empanelment (health system level), 2) standard treatment protocol (national policy level), 3) encouragement of fixed-dose combination therapy (health system level), 4) team-based care (health worker level), and 5) home blood pressure monitoring and health coaching (patient-level).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

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

  • Adults (≥18 years).
  • Elevated blood pressure (Systolic Blood Pressure ≥ 130 mmHg or Diastolic Blood Pressure ≥ 80 mmHg) documented or measured by a health care professional (e.g., physician, Community Health Extension Worker, or Community Health Officer).

排除标准

  • Individuals who are not yet adults (minors)
  • Prisoners or other detained individuals.

结局指标

主要结局

Change from Baseline Slope of Treatment Rate

时间窗: Through study completion, 45 months

Hypertension treatment using any blood pressure lowering drug. Treatments rates are calculated monthly, over 9 months of baseline and 39 months of intervention.

Change from Baseline Slope of Control Rate

时间窗: Through study completion, 45 months

Hypertension control is defined as a Systolic Blood Pressure \<140 mmHg and Diastolic Blood Pressure \<90 mmHg. Control rates are calculated monthly, over 9 months of baseline and 39 months of intervention.

次要结局

未报告次要终点

研究者

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

Mark Huffman

Professor of Medicine and Global Health Center Co-Director

Washington University School of Medicine

研究点 (60)

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