Cardiovasculaire risicobeoordeling en preventieonderzoek op basis van dynamische monitoring (CRITICALLY)
Cardiovasculaire risicobeoordeling en op dynamische monitoring gebaseerde preventiestudie voor kwaliteitsevaluatie van eerstelijnszorg in Yinzhou
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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Xun TANG, PhD, MHS
- Telefoonnummer: +86-10-82801528 ext 317
- E-mail: tangxun@bjmu.edu.cn
Studie Locaties
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Zhejiang
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Ningbo, Zhejiang, China, 315100
- Werving
- Yinzhou District Center for Disease Control and Prevention
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Contact:
- Peng SHEN, MPH
- Telefoonnummer: +86-574-87418718
- E-mail: shen-peng@foxmail.com
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Intervention arm
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. |
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). 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"). |
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Geen tussenkomst: Control arm
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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Primary Outcome of Phase I: Change in cardiovascular risk score
Tijdsspanne: 24 months after baseline
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The change in cardiovascular risk scores calculated by 2019 WHO laboratory-based risk charts |
24 months after baseline
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Primary Outcome of Phase II: Major adverse cardiovascular events (MACE)
Tijdsspanne: 60 months after baseline
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Incidence of coronary heart disease, stroke, heart failure and all-cause mortality |
60 months after baseline
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Secondary Outcome of Phase I: Change in systolic blood pressure
Tijdsspanne: 24 months after baseline
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the change in systolic blood pressure from baseline |
24 months after baseline
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Secondary Outcome of Phase I: Change in total cholesterol
Tijdsspanne: 24 months after baseline
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the change in total cholesterol from baseline |
24 months after baseline
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Secondary Outcome of Phase I: Change in low-density lipoprotein cholesterol
Tijdsspanne: 24 months after baseline
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the change in low-density lipoprotein cholesterol from baseline |
24 months after baseline
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Secondary Outcome of Phase II: Change in health-related quality of life
Tijdsspanne: 60 months after baseline
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Measured using the EuroQol-5 Dimensions-5L(EQ-5D) |
60 months after baseline
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Other Pre-specified Outcome of Phase II: Incremental cost-effectiveness ratio (ICER)
Tijdsspanne: 60 months after baseline
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the incremental cost-effectiveness ratio (ICER) of the management provided by the interventions compared to the usual care |
60 months after baseline
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Xun TANG, PhD, MHS
- Hoofdonderzoeker: Pei GAO, PhD
Publicaties en nuttige links
Algemene publicaties
- Lin H, Tang X, Shen P, Zhang D, Wu J, Zhang J, Lu P, Si Y, Gao P. Using big data to improve cardiovascular care and outcomes in China: a protocol for the CHinese Electronic health Records Research in Yinzhou (CHERRY) Study. BMJ Open. 2018 Feb 12;8(2):e019698. doi: 10.1136/bmjopen-2017-019698.
- Liu XF, Li QQ, Chen WY, et al. A dynamic risk-based early warning monitoring system for population-based management of cardiovascular disease. Fundamental Research. 2021:534-542.
- Liu X, Shen P, Zhang D, Sun Y, Chen Y, Liang J, Wu J, Zhang J, Lu P, Lin H, Tang X, Gao P. Evaluation of Atherosclerotic Cardiovascular Risk Prediction Models in China: Results From the CHERRY Study. JACC Asia. 2022 Jan 4;2(1):33-43. doi: 10.1016/j.jacasi.2021.10.007. eCollection 2022 Feb.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IRB00001052-21060
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
According to the Administrative Regulations on Human Genetic Resources issued by the State Council of the People's Republic of China in 2019, we are waiting for the approval of IPD sharing.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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