Cardiovascular Diseases
Conditions
Keywords
primary prevention, cluster randomized trial, cardiovascular risk assessment
Brief summary
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.
Detailed description
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.
Interventions
OTHERFrequent and automatic cardiovascular risk assessment
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.
OTHERDynamic risk monitoring
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).
OTHERRegular GP visits
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).
Sponsors
Yinzhou District Center for Disease Control and Prevention
Peking University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Residents in the Yinzhou District have a unique health ID; * Aged 40 to 79 years at the baseline enrollment; * With high risk of cardiovascular disease evaluated by the 2019 WHO laboratory-based risk models (10-year risk≥10%);
Exclusion criteria
* Have a history of coronary heart disease, stroke or heart failure; * Patients with a diagnosis of cancer; * Refused to provide written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome of Phase II: Major adverse cardiovascular events (MACE) | 60 months after baseline | Incidence of coronary heart disease, stroke, heart failure and all-cause mortality |
| Primary Outcome of Phase I: Change in cardiovascular risk score | 24 months after baseline | The change in cardiovascular risk scores calculated by 2019 WHO laboratory-based risk charts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcome of Phase I: Change in total cholesterol | 24 months after baseline | the change in total cholesterol from baseline |
| Secondary Outcome of Phase II: Change in health-related quality of life | 60 months after baseline | Measured using the EuroQol-5 Dimensions-5L(EQ-5D) |
| Secondary Outcome of Phase I: Change in low-density lipoprotein cholesterol | 24 months after baseline | the change in low-density lipoprotein cholesterol from baseline |
| Secondary Outcome of Phase I: Change in systolic blood pressure | 24 months after baseline | the change in systolic blood pressure from baseline |
Other
| Measure | Time frame | Description |
|---|---|---|
| Other Pre-specified Outcome of Phase II: Incremental cost-effectiveness ratio (ICER) | 60 months after baseline | the incremental cost-effectiveness ratio (ICER) of the management provided by the interventions compared to the usual care |
Countries
China
Contacts
Primary ContactXun TANG, PhD, MHS
Outcome results
None listed