跳至主要内容
临床试验/NCT07089810
NCT07089810尚未招募不适用

Digital Intervention Based on BCW Theory Has a High Blood Pressure in High-risk Population of Stroke Study on the Effect of Stress on Self-management Behavior of Patients

Affiliated Hospital of Nantong University0 个研究点目标入组 120 人开始时间: 2025年8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
入组人数
120
主要终点
Self-rating Depression Scale (PHQ-9)

研究概览

简要总结

Stroke is the second leading cause of death in the world, and the number of stroke patients in China ranks the first in the world. Hypertension is the most important risk factor. Studies have shown that 80% of stroke can be prevented by controlling risk factors. However, the management level of hypertension patients in China is still low, and their self-management ability is insufficient.

Digital health management, such as remote monitoring, AI and mobile health platforms, provides a new way for hypertension prevention and control. Foreign studies have shown that digital interventions can effectively improve patients' self-management behaviors, such as diet, exercise and blood pressure control. Interventions based on wechat, APP and other tools in China have also achieved positive results, but face challenges such as patient acceptance, system adaptation and data continuity.

Based on behavior change wheel (BCW) theory ** and digital platform, this study formulated personalized intervention programs for hypertension patients in high-risk groups of stroke, and promoted health behavior change from three aspects of ** ability, motivation and opportunity **. By improving disease cognition and strengthening self-management, the incidence of stroke can be ultimately reduced, and a new strategy for hypertension prevention and control in the community can be provided.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • •(1) hypertensive patients at high risk of stroke screened in the National Screening and Intervention Project for High-risk Population of Stroke (2) willing to participate Cooperate and sign the informed consent form

排除标准

  • •(1) TIA and stroke patients (2) severe cognitive impairment (MMSE≤9) and (3) inability to use smartphones (4) Refusal to participate

研究组 & 干预措施

Digital intervention has a high blood pressure in the high-risk population of stroke Study

Experimental

The chronic disease management App developed by the Affiliated Hospital of Nantong University was used to digitally manage hypertension patients, construct personalized intervention programs for such patients, and implement effective supervision and management on the platform. By strengthening the cognition of the population on the disease, it can increase their ability to self-management health, promote the change of health behavior, and ultimately reduce the incidence of stroke

干预措施: Digital intervention has a high blood pressure in the high-risk population of stroke Study on the effect of stress on self-management behavior of patients (Device)

The control group was given health education according to the community management routine of the 20

No Intervention

Patients in the control group will receive routine hypertension management in the community according to the recommendations of the Chinese Guidelines for the Prevention and Treatment of Hypertension (2024), including health education, lifestyle intervention, blood pressure monitoring, and regular follow-up **, but without the use of digital chronic disease management App.

结局指标

主要结局

Self-rating Depression Scale (PHQ-9)

时间窗: From the beginning of enrollment to the end 6 months later

Generalized Anxiety Disorder-7 (GAD-7)

时间窗: From the beginning of enrollment to the end 6 months later

Hypertension Self-Management Behavior Rating Scale (HPSMBRS)

时间窗: From the beginning of enrollment to the end 6 months later

Hypertension Knowledge Scale (HK-LS)

时间窗: From the beginning of enrollment to the end 6 months later

Stroke premonitory symptom alertness assessment questionnaire

时间窗: From the beginning of enrollment to the end 6 months later

Hypertension Self-Management Behavior Rating Scale (HPSMBRS)

时间窗: From the beginning of enrollment to the end 6 months later

Hypertension Knowledge Scale (HK-LS)

时间窗: From the beginning of enrollment to the end 6 months later

Stroke premonitory symptom alertness assessment questionnaire

时间窗: From the beginning of enrollment to the end 6 months later

Self-rating Depression Scale (PHQ-9)

时间窗: From the beginning of enrollment to the end 6 months later

Generalized Anxiety Disorder-7 (GAD-7)

时间窗: From the beginning of enrollment to the end 6 months later

次要结局

  • Blood lipid (mmol/L)(From the beginning of enrollment to the end 6 months later)
  • Fasting blood glucose (mmol/L)(From the beginning of enrollment to the end 6 months later)
  • Blood Pressure (mmHg)(From the beginning of enrollment to the end 6 months later)
  • Glycosylated hemoglobin (HbA1c)(%)(From the beginning of enrollment to the end 6 months later)
  • Blood homocysteine (Hcy) (mmol/L)(From the beginning of enrollment to the end 6 months later)
  • Is the risk of stroke reduced? : Risk prediction for atherosclerotic cardiovascular disease in China Prediction for ASCVD Risk in China, China-PAR(From the beginning of enrollment to the end 6 months later)
  • Blood Pressure (mmHg)(From the beginning of enrollment to the end 6 months later)
  • Blood lipid (mmol/L)(From the beginning of enrollment to the end 6 months later)
  • Fasting blood glucose (mmol/L)(From the beginning of enrollment to the end 6 months later)
  • Glycosylated hemoglobin (HbA1c)(%)(From the beginning of enrollment to the end 6 months later)
  • Blood homocysteine (Hcy) (mmol/L)(From the beginning of enrollment to the end 6 months later)
  • Is the risk of stroke reduced? : Risk prediction for atherosclerotic cardiovascular disease in China Prediction for ASCVD Risk in China, China-PAR(From the beginning of enrollment to the end 6 months later)

研究者

申办方类型
Other
责任方
Sponsor

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