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临床试验/NCT06141278
NCT06141278尚未招募不适用

China Hypertension and Diabetes Care Cascade Study

Peking Union Medical College0 个研究点目标入组 14,400 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
14,400
主要终点
Change of blood glucose control at baseline and at 12 month

研究概览

简要总结

This implementation study aims to identify priorities and formulate strategies to overcome health service delivery bottlenecks associated with hypertension and diabetes in rural China. Leveraging implementation frameworks, the study seeks to unravel the complexities embedded within the care cascade, paving the way for targeted interventions. Addressing the nuanced dynamics of the care cascade, this research will provide indispensable insights for optimising healthcare delivery in resource-limited settings, ultimately informing global perspectives on chronic disease management.

The overall aim of this study is to enhance the control of hypertension and diabetes in rural China through a systematic assessment and improvement of the care cascade, specifically:

  1. To describe the cascade gap and identify barriers and facilitators at each cascade stage.
  2. To develop practical interventions through stakeholder co-design.
  3. To assess the effectiveness of developed interventions and evaluate implementation strategies.

详细描述

Hypertension and type 2 diabetes present substantial challenges to the Chinese health system. A nationwide survey revealed a hypertension prevalence of 37.2% among Chinese adults over 35, with only 44.7% aware of their diagnosis and a mere 30.1% receiving antihypertensive treatment, resulting in an overall control rate of 7.2% [1]. Similarly, diabetes prevalence in 2018 stood at 12.9%, with awareness and treatment rates of 37% and 33%, respectively [2]. Achieving hypertension and diabetes control is conditional on successful progression through screening, diagnosis, management, and control-a continuum demanding care continuity. The care cascade analysis, originally devised for communicable diseases (i.e., HIV and tuberculosis), offers a systematic approach that dissects disease management into a series of interconnected service delivery stages [3, 4]. This method evaluates patient progression, unveiling critical drop-offs between each stage. Despite existing population-based surveys detailing the awareness, prevalence and treatment of hypertension and diabetes in China, few studies provide a systematic diagnosis of what happens between stages and devise interventions tailored to each stage of the care cascade.

This implementation study aims to identify priorities and formulate strategies to overcome health service delivery bottlenecks associated with hypertension and diabetes in rural China. Leveraging implementation frameworks, the study seeks to unravel the complexities embedded within the care cascade, paving the way for targeted interventions. Addressing the nuanced dynamics of the care cascade, this research will provide indispensable insights for optimising healthcare delivery in resource-limited settings, ultimately informing global perspectives on chronic disease management.

The overall aim of this study is to enhance the control of hypertension and diabetes in rural China through a systematic assessment and improvement of the care cascade, specifically:

  1. To describe the cascade gap and identify barriers and facilitators at each cascade stage.
  2. To develop practical interventions through stakeholder co-design.
  3. To assess the effectiveness of developed interventions and evaluate implementation strategies.

This is a hybrid design implementation study using mixed methods and integrates diverse implementation theories, models, and frameworks. The theoretical model synthesises the process model, determinant framework, and evaluation framework under the theory of implementation science (Figure 1). The Consolidated Framework for Implementation Research (CFIR) framework identifies multilevel factors influencing implementation. The chronic care model (CCM) is used to inform intervention development. The RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework is used to assess interventions across multiple dimensions. Normalisation Process Theory (NPT) is applied to measure elements critical for successful implementation and integration into routine work.

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
Single (Outcomes Assessor)

入排标准

年龄范围
35 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Permanent residents of the surveyed village (residing for more than six months each year).
  • Age between 35 and 74 years old.

排除标准

  • Individuals with severe mental disorders or communication barriers.
  • Individuals planning to move out of the village within the next year.
  • Expected life expectancy of less than one year.
  • Pregnant or lactating individuals.
  • Individuals who are currently away (i.e. hospitalized, or residing elsewhere) so that cannot participate in the survey.

结局指标

主要结局

Change of blood glucose control at baseline and at 12 month

时间窗: Baseline and at 12 month

The proportion of diabetes patients who have achieved HbA1c \< 6.5%

Change of blood pressure control at baseline and at 12 month

时间窗: Baseline and at 12 month

The proportion of hypertension patients who have achieved BP control. We defined control as BP \< 140/90 mmHg or lower in complex cases, such as diabetes

Change of SBP at baseline and at 12 month

时间窗: Baseline and at 12 month

Blood pressure is measured after the participant has rested for at least 15 minutes. Blood pressure is measured at least three times at 3 minutes intervals using the appropriate cuff size and a Digital Automatic Blood Pressure Monitor

次要结局

  • Treatment rate at baseline and at 12 month(Baseline and at 12 month)
  • Screening rate at baseline and at 12 month(Baseline and at 12 month)
  • Diagnosis rate at baseline and at 12 month(Baseline and at 12 month)

研究者

发起方
Peking Union Medical College
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xuejun Yin

Dr.

Peking Union Medical College

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