Évaluation du risque cardiovasculaire et essai de prévention basé sur la surveillance dynamique (CRITICALLY)
Évaluation du risque cardiovasculaire et essai de prévention basé sur la surveillance dynamique pour l'évaluation de la qualité des soins primaires à 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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Xun TANG, PhD, MHS
- Numéro de téléphone: +86-10-82801528 ext 317
- E-mail: tangxun@bjmu.edu.cn
Lieux d'étude
-
-
Zhejiang
-
Ningbo, Zhejiang, Chine, 315100
- Recrutement
- Yinzhou District Center for Disease Control and Prevention
-
Contact:
- Peng SHEN, MPH
- Numéro de téléphone: +86-574-87418718
- E-mail: shen-peng@foxmail.com
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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"). |
|
Aucune intervention: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Primary Outcome of Phase I: Change in cardiovascular risk score
Délai: 24 months after baseline
|
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)
Délai: 60 months after baseline
|
Incidence of coronary heart disease, stroke, heart failure and all-cause mortality |
60 months after baseline
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Secondary Outcome of Phase I: Change in systolic blood pressure
Délai: 24 months after baseline
|
the change in systolic blood pressure from baseline |
24 months after baseline
|
|
Secondary Outcome of Phase I: Change in total cholesterol
Délai: 24 months after baseline
|
the change in total cholesterol from baseline |
24 months after baseline
|
|
Secondary Outcome of Phase I: Change in low-density lipoprotein cholesterol
Délai: 24 months after baseline
|
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
Délai: 60 months after baseline
|
Measured using the EuroQol-5 Dimensions-5L(EQ-5D) |
60 months after baseline
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Other Pre-specified Outcome of Phase II: Incremental cost-effectiveness ratio (ICER)
Délai: 60 months after baseline
|
the incremental cost-effectiveness ratio (ICER) of the management provided by the interventions compared to the usual care |
60 months after baseline
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Xun TANG, PhD, MHS
- Chercheur principal: Pei GAO, PhD
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB00001052-21060
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .