The CRITICALLY study is a cluster randomized trial that will evaluate the effectiveness of a risk-based dynamic monitoring strategy for the primary prevention of cardiovascular high-risk Chinese adults.
The objective of the study is to evaluate the effectiveness of a risk-based management strategy on cardiovascular risk scores (calculated by the 2019 WHO cardiovascular risk charts) in 24 months (Phase I) and the incidence of major adverse cardiovascular events in 60 months (Phase II). Totally 216 clinics in Yinzhou District, China will be randomized to the intervention or the control arms with usual care. The interventions supported by the web-based decision support system include (1) cardiovascular risk assessment, (2) dynamic risk monitoring, and (3) regular visits by the general practitioner every three months. Only usual care will be provided in the control arm. The primary outcome is the change in cardiovascular risk scores for Phase I and the incidence of the composite endpoint of coronary heart disease, stroke, heart failure and all-cause mortality for Phase II. If the comprehensive strategy is proven effective, it could provide evidence for the primary prevention of cardiovascular diseases using digital health technology.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
22,032
The 10-year cardiovascular risk scores using the 2019 World Health Organization (WHO) laboratory-based risk charts will be automatically calculated using the latest health information on an EHR-based system per month.
High-risk individuals will be reassessed by the Dynamic Risk-based Early wArning and Monitoring (DREAM) system to obtain the short-term risk. The DREAM system will send a text message about advice to the high-risk individual every month. The text message includes information on the health status (e.g., current cardiovascular risk, level of blood pressure and lipid) and real-time warning messages (e.g., high short-term risk).
Yinzhou District Center for Disease Control and Prevention
Ningbo, Zhejiang, China
RECRUITINGPrimary Outcome of Phase I: Change in cardiovascular risk score
The change in cardiovascular risk scores calculated by 2019 WHO laboratory-based risk charts
Time frame: 24 months after baseline
Primary Outcome of Phase II: Major adverse cardiovascular events (MACE)
Incidence of coronary heart disease, stroke, heart failure and all-cause mortality
Time frame: 60 months after baseline
Secondary Outcome of Phase I: Change in systolic blood pressure
the change in systolic blood pressure from baseline
Time frame: 24 months after baseline
Secondary Outcome of Phase I: Change in total cholesterol
the change in total cholesterol from baseline
Time frame: 24 months after baseline
Secondary Outcome of Phase I: Change in low-density lipoprotein cholesterol
the change in low-density lipoprotein cholesterol from baseline
Time frame: 24 months after baseline
Secondary Outcome of Phase II: Change in health-related quality of life
Measured using the EuroQol-5 Dimensions-5L(EQ-5D)
Time frame: 60 months after baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The general practitioners will communicate with the participants based on the information automatically generated from the DREAM system every three months: each participant's cardiovascular risk score, health status (e.g., diabetes mellitus and/or hypertension), and Chinese guidelines-based recommendations (e.g., "for the management of dyslipidemia, to provide clear treatment targets for high-risk participants").