跳至主要内容
临床试验/NCT06949306
NCT06949306尚未招募不适用

Intervention of a Digital Health Management Program in Patients With Cardiometabolic Disorders: a Real-world Study

Shanghai 10th People's Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
300
试验地点
1
主要终点
Changes in diastolic blood pressure after 24 weeks

研究概览

简要总结

The aim of this study is to construct a digital precision intervention system for cardiometabolism disorders based on the characteristics of the Chinese population, focusing on the core components of metabolic syndrome such as hypertension, hyperglycemia, and obesity. Through dynamic monitoring of wearable devices, the individualized risk factors (including genetic predisposition, lifestyle, and psychological factors) of metabolic disorders were systematically analyzed, and dynamic intervention strategies were formulated accordingly. The closed-loop management of "monitor-feedback-optimization" based on the digital platform will provide patients with one-stop metabolic risk assessment and panoramic health management plan, realizing a paradigm shift from "generalized intervention" to "precise regulation". By reducing the abnormal fluctuations of key metabolic indicators such as blood pressure, blood glucose, and blood lipids, the risk of cardiovascular events will eventually be reduced, the long-term quality of life of patients will be improved, and a practical path of "digital therapy" can be promoted for the prevention and control of chronic diseases in China

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age 18-65 years old;
  • •Meet one of the following three conditions:
  • •Diastolic hypertension (systolic blood pressure < 140 MMHG and diastolic blood pressure ≥90mmHg)
  • •Glycosylated hemoglobin (6.0-6.5)
  • •Obesity (BMI≥28kg/m²)
  • •Mild hyperlipemia: total cholesterol (TC) ≥5.2 mmol/L and < 6.2 mmol/L, or low-density lipoprotein cholesterol (LDL-C) ≥3.4 mmol/L and < 4.1 mmol/L
  • •Antihypertensive or lipid-lowering medications have not been started
  • •Use a smartphone and volunteer

排除标准

  • •Complicated with chronic liver and kidney disease, coronary heart disease, heart failure and severe valvular disease
  • •Previous cardiovascular and cerebrovascular events
  • •Diastolic blood pressure ≥99mmHg
  • •Glycated hemoglobin ≥6.5
  • •Other life expectancy such as cancer is less than 5 years
  • •Participate in other clinical trials

研究组 & 干预措施

Cardiovascular digital management group

Experimental

Participants used a bracelet and an APP assistant for lifestyle interventions

干预措施: Bracelet, assistant, APP: the "golden triangle" of smart life (Other)

结局指标

主要结局

Changes in diastolic blood pressure after 24 weeks

时间窗: 24 weeks following intervention

次要结局

  • Values for changes in Hba1c or BMI or CAI after 24 weeks(24 weeks following intervention)

研究者

发起方
Shanghai 10th People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ya-Wei Xu

professor of Medicine

Shanghai 10th People's Hospital

研究点 (1)

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