心血管リスク評価と動的モニタリングに基づく予防試験 (CRITICALLY)
鄞州市におけるプライマリケアの質評価のための心血管リスク評価と動的モニタリングに基づく予防試験
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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Xun TANG, PhD, MHS
- 電話番号：+86-10-82801528 ext 317
- メール：tangxun@bjmu.edu.cn
研究場所
-
-
Zhejiang
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Ningbo、Zhejiang、中国、315100
- 募集
- Yinzhou District Center for Disease Control and Prevention
-
コンタクト：
- Peng SHEN, MPH
- 電話番号：+86-574-87418718
- メール：shen-peng@foxmail.com
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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"). |
|
介入なし：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Primary Outcome of Phase I: Change in cardiovascular risk score
時間枠：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)
時間枠：60 months after baseline
|
Incidence of coronary heart disease, stroke, heart failure and all-cause mortality |
60 months after baseline
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Secondary Outcome of Phase I: Change in systolic blood pressure
時間枠：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
時間枠：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
時間枠：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
時間枠：60 months after baseline
|
Measured using the EuroQol-5 Dimensions-5L(EQ-5D) |
60 months after baseline
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Other Pre-specified Outcome of Phase II: Incremental cost-effectiveness ratio (ICER)
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Xun TANG, PhD, MHS
- 主任研究者：Pei GAO, PhD
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。