Cardiovascular Risk Assessment and Dynamic Monitoring-based Prevention Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cardiovascular Risk Assessment and dynamIc Monitoring-based Prevention Trial for prImary Care quALity evaLuation in Yinzhou

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Other: Frequent and automatic cardiovascular risk assessment
* Other: Dynamic risk monitoring
* Other: Regular GP visits


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>The interventions include cardiovascular risk assessment, dynamic risk monitoring, and regular general practitioner (GP) visits. The frequency of risk assessment, risk monitoring, and automatic mobile texting will be once per month, while regular GP visits will be once per three months. | Other: Frequent and automatic cardiovascular risk assessment<br>* 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.<br>Other: Dynamic risk monitoring<br>* 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).<br>Other: Regular GP visits<br>* 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).<br>|
| No Intervention: Control arm<br>Current regular management (usual care) will be kept in the control arm. The management objectives are for patients with hypertension or diabetes mellitus. The frequency of follow-up is at least once per three months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Outcome of Phase I: Change in cardiovascular risk score | The change in cardiovascular risk scores calculated by 2019 WHO laboratory-based risk charts | 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 | 60 months after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Outcome of Phase I: Change in systolic blood pressure | the change in systolic blood pressure from baseline | 24 months after baseline | 
| Secondary Outcome of Phase I: Change in total cholesterol | the change in total cholesterol from baseline | 24 months after baseline | 
| Secondary Outcome of Phase I: Change in low-density lipoprotein cholesterol | the change in low-density lipoprotein cholesterol from baseline | 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) | 60 months after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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primary prevention, cluster randomized trial, cardiovascular risk assessment