NCT04289701

Hypertension Registry of "Hypertension Prevention and Control Initiative in China"

The National Hypertension Registry Study of the "Hypertension Prevention and Control Initiative in China" Project

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200,000 (estimated)
• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Hypertension is the leading preventable risk factor of cardiovascular disease globally and in China. Unparalleled to remarkable increase of hypertension burden in China, blood pressure(BP) control is inadequate. A political public health project, "Hypertension Prevention and Control Initiative in China(Chronic Disease Demonstration District Construction)", was initiated in October 2019 for explore a feasible and reproducible archetype for hypertension management and to improve the registration, management, treatment and control rates of hypertension in China. The project is designed to consecutively implement health service strategies in 40 pilot counties covering 31 provinces and around 200,000 hypertension patients in mainland China, via the National Medical Alliance for Hypertension(NMAH). The Hypertension Registry study aims to registry, follow up and observe the clinical features, treatment, blood pressure control and outcomes of all hypertension patients managed in the "Hypertension Prevention and Control Initiative in China" project.

Detailed description

Objective: The study aims to investigate the clinical features, treatment, blood pressure control and outcomes of hypertension patients managed in the "Hypertension Prevention and Control Initiative in China" project. Study Type: A national, multicenter, observational, prospective cohort study. Study Design: The cardinal contents of this registry study are as follows: Introduce the Digital Information System and train in completing case report forms. Collect sociodemographic information, lifestyle behaviors, self-reported personal medical history, BP, anthropometric measurements, medication at registration, laboratory investigations of hypertension patients managed in the "Hypertension Prevention and Control Initiative in China" project. Build a baseline database of hypertension patients. Gather the follow up information including general, clinical, therapeutic, prognostic data of all recruits at 3-month intervals over 2 years and build up the follow-up database. Data management, quality control and statistic analysis: Digital Information Platform for data capture, document and cloud computing has been built and the investigators will manage and analyze data in align with key indicators. The investigators have invited professional statistic analysts to assist analyzing data and a third party to supervise data quality. Ethics: The Ethics Committee of Fuwai Hospital approved this study. Informed consents before patient enrollment are required.

Conditions

• Hypertension

Interventions

Type	Name	Description
OTHER	Health Services for Systematic Hypertension Management	The systematic hypertension management health services from the "Hypertension prevention and control initiative in China" project. Main services are as follows: 1. Healthcare provider training and patient education. 2. Standardized guideline-based hypertension diagnosis, treatment and management recommendation. 3. Patient-centered, pan-cycle continuous hypertension management via the organizing framework of NMAH and sharing digital platform. 4. Periodical Patient follow-up via blood pressure monitor-sharing system and in collaboration with other basic local public health programs. 5. Outcome and performance evaluation quarterly. 6. Incentives for healthcare organizations and primary healthcare providers, and subsidies to patients. 7. Certification for "Honorary Hypertension Centers" at county levels and establishment for hypertension clinics at primary care centers.

Timeline

• Start date: 2019-10-08
• Primary completion: 2022-12-30
• Completion: 2024-12-30
• First posted: 2020-02-28
• Last updated: 2020-02-28

Locations

11 sites across 1 country: China