심혈관 위험 평가 및 동적 모니터링 기반 예방 시험 (CRITICALLY)
Yinzhou의 일차 진료 품질 평가를 위한 심혈관 위험 평가 및 동적 모니터링 기반 예방 시험
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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Xun TANG, PhD, MHS
- 전화번호: +86-10-82801528 ext 317
- 이메일: tangxun@bjmu.edu.cn
연구 장소
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Zhejiang
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Ningbo, Zhejiang, 중국, 315100
- 모병
- Yinzhou District Center for Disease Control and Prevention
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연락하다:
- Peng SHEN, MPH
- 전화번호: +86-574-87418718
- 이메일: shen-peng@foxmail.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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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간섭 없음: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Primary Outcome of Phase I: Change in cardiovascular risk score
기간: 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)
기간: 60 months after baseline
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Incidence of coronary heart disease, stroke, heart failure and all-cause mortality |
60 months after baseline
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Secondary Outcome of Phase I: Change in systolic blood pressure
기간: 24 months after baseline
|
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
기간: 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
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Other Pre-specified Outcome of Phase II: Incremental cost-effectiveness ratio (ICER)
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Xun TANG, PhD, MHS
- 수석 연구원: Pei GAO, PhD
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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