Clinical Landscape of Epidemiology and Assessment of Results in Hypertension
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 15,000
- 试验地点
- 1
- 主要终点
- Uncontrolled blood pressure
概览
简要总结
This is a retrospective observational cohort study based on secondary use of routinely collected electronic health data. The design was selected to enable population-level characterisation of treatment patterns and clinical inertia (both diagnostic and therapeutic) in the management of hypertension across diverse settings in Brazil's public primary care system (SUS).
详细描述
This is a retrospective observational cohort study based on secondary use of routinely collected electronic health data. The design was selected to enable population-level characterisation of treatment patterns and clinical inertia (both diagnostic and therapeutic) in the management of hypertension across diverse settings in Brazil's public primary care system (SUS).
The retrospective cohort design allows for efficient use of existing clinical data to evaluate real-world practice against national guideline recommendations. The primary outcomes relate to treatment decisions and delays rather than interventional effects; therefore, an observational design is methodologically appropriate and ethically preferable.
The study will be conducted across 05 Brazilian municipalities participating in the epHealth Primary Care Solutions platform. These municipalities span multiple regions and reflect heterogeneity in socio-demographic context, healthcare infrastructure, and epidemiological profiles.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years at the time of Hypertension diagnosis
- •Hypertension diagnosis as retrieved from registered ICD codes or CIAP Codes (primary care codes) in the EMR , OR At least two blood pressure measurements ≥140/90 mmHg during the study period. The blood measurements should be consecutive and obtained within a 30 days period.
- •Continuous follow-up in the same municipality for at least 6 months after index measurement.
- •Availability of structured EMR data including clinical encounters, diagnoses, and prescriptions
排除标准
- •\- Patients with incomplete data or not traceable in the registration systems
结局指标
主要结局
Uncontrolled blood pressure
时间窗: through study completion, an average of 1 year
Proportion of patients with uncontrolled blood pressure (BP ≥ 140/90 mmHg) who did not receive treatment intensification within 3 months of a recorded elevated BP.
次要结局
- Antihypertensive treatment(through study completion, an average of 1 year)
- Risk stratification(through study completion, an average of 1 year)