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临床试验/NCT04183413
NCT04183413已完成不适用

Strengthening Primary Healthcare Delivery for Diabetes and Hypertension in Eswatini: A Cluster-randomized Trial

University Hospital Heidelberg1 个研究点 分布在 1 个国家目标入组 3,500 人开始时间: 2021年11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
3,500
试验地点
1
主要终点
Glycemic control (continuous) among adults with diabetes

研究概览

简要总结

The WHO-PEN@Scale project is a three-arm cluster-randomized trial that is investigating the population-level effects of a healthcare reform in Eswatini, which aims to strengthen primary care for diabetes and hypertension. Prior to the reform, healthcare for diabetes and hypertension was mostly provided through physician-led teams in hospital outpatient departments. The healthcare reform aims to strengthen the provision of nurse-led care for diabetes and hypertension in primary healthcare facilities and community health worker-led care for these conditions in the facilities' catchment areas. The reform will broadly be guided by the World Health Organization's "Package of Essential Noncommunicable Disease Interventions for Primary Health Care in Low-Resource Settings" (WHO-PEN). The trial will take place at 84 clusters (a primary healthcare facility and its catchment area) across the country.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Glycemic control (continuous) among adults with diabetes

时间窗: 12 months

Mean glycated haemoglobin (HbA1c) among adults aged 40 years and older with diabetes

Systolic blood pressure among adults with hypertension

时间窗: 12 months

Mean systolic blood pressure among adults aged 40 years and older with hypertension

次要结局

  • HbA1c among adults with diabetes or prediabetes(12 months)
  • Glycemic control (binary) among adults with diabetes(12 months)
  • Glycemic control (binary) among adults with diabetes or prediabetes(12 months)
  • Awareness of one's diabetes diagnosis(12 months)
  • Awareness of one's diabetes or prediabetes diagnosis(12 months)
  • Probability of having been tested for diabetes among adults with diabetes or prediabetes(12 months)
  • Probability of smoking among adults with diabetes, prediabetes, or hypertension(12 months)
  • Systolic blood pressure among adults with diabetes or prediabetes(12 months)
  • Diastolic blood pressure among adults with diabetes(12 months)
  • Time spent doing moderate- or vigorous-intensity exercise among adults with diabetes, prediabetes, or hypertension(12 months)
  • Awareness of one's hypertension diagnosis(12 months)
  • Probability of being treated for hypertension among adults with hypertension(12 months)
  • Probability of being treated for diabetes among adults with diabetes(12 months)
  • Systolic blood pressure among adults with diabetes(12 months)
  • Probability of having been tested for diabetes among adults with diabetes(12 months)
  • Diastolic blood pressure among adults with diabetes or prediabetes(12 months)
  • Diastolic blood pressure among adults with hypertension(12 months)
  • Probability of having been tested for hypertension among adults with hypertension(12 months)
  • Hypertension control (binary) among adults with hypertension(12 months)
  • Frequency of drinking alcohol in the past 12 months among adults with diabetes, prediabetes, or hypertension(12 months)
  • 21. Knowledge on diabetes and hypertension among adults with diabetes, prediabetes, or hypertension(12 months)

研究者

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

Till Bärnighausen

Prof. Dr. Dr. Till Bärnighausen

University Hospital Heidelberg

研究点 (1)

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