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临床试验 NCT06150508 针对高血压，糖尿病目前状态未知。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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首尔大学Randomized Controlled Trial of the Smart O2O Model Development for Chronic Diseases Management Through Digital Health 1,000 随机化 数字健康 生活方式
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临床试验NCT06150508是一项针对高血压，糖尿病的干预性研究试验，目前试验状态为状态未知。试验始于2023年11月1日，计划招募1,000名患者。该研究由首尔大学主导，预计于2024年12月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2023年11月29日。
简要概括
Objectives The aim of this intervention is to assess how well and how efficiently the O2O Service Model works in delivering primary healthcare and managing chronic diseases for patients living in Pyeongchang-gun at the local government level.
Trial design This is a randomized controlled trial with restricted, batch, blocked and individual random assignment. Investigators will allocate 1,000 participants from Pyeongc...
显示更多详细描述
Objectives The objective of this intervention is to evaluate the effectiveness and efficiency of the Online-to-Offline(O2O) Service Model developed to provide primary healthcare and management of chronic diseases targeting patients residing in Pyeongchang-gun at the local government level.
The randomized controlled trial of this intervention will help verifying the model, and provide valuable information about the e...
显示更多官方标题
Randomized Controlled Trial of the Smart Online-to-Offline Model Development for Chronic Diseases Management Through Digital Health in Real World Setting
疾病
高血压糖尿病出版物
关于此临床试验发表的科学文章和研究论文：其他研究标识符
- IRB No: 2308-183-1463
主要目的
卫生服务研究
分配方式
随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
无干预Comparative group Comparators will not be provided with the O2O service, but will be treated as usual (TAU) through the 1st tier health care clinics/centers in Pyeongchang-gun county. | 不适用 |
实验性Intervention group Intervention group will use the service app "Value Health" for life-log recording. They regularly record life-log data such as blood pressure, blood glucose, medication, diet, exercise, and weight. (As mentioned, glucose level and blood pressure measurements will be automatically shared with the app using Bluetooth function of the provided checkers.) Interventions through application include automated message and ala...显示更多 | O2O digital healthcare service The O2O service includes a mobile app and web-based portal that allows patients to monitor their blood glucose levels, track their medication use and physical activity, receive personalized feedback and education, and communicate with healthcare providers. The treatment group will receive a blood sugar checker and blood pressure checker that send the records automatically to the application through Bluetooth. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Blood pressure | Diastolic blood pressure, Systolic blood pressure (mmHg) | Once each at baseline for all participants, and 6 months after for hypertension patient or 9 months after for diabetes patient (Total 2 times) |
Fasting blood glucose level (FBG) in mg/dL | Glucose level | Once each at baseline for all participants, and 6 months after for hypertension patient or 9 months after for diabetes patient (Total 2 times) |
Glucose level | HbA1c in percent | Once each at baseline for all participants, and 6 months after for hypertension patient or 9 months after for diabetes patient (Total 2 times) |
Lipid profile | Cholesterol, Triglyceride(TG), HDL Cholesterol, LDL Cholesterol(All in ㎎/㎗) | Once each at baseline for all participants, and 6 months after for hypertension patient or 9 months after for diabetes patient (Total 2 times) |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Body measurement | Weight in kilogram, height in meters, BMI kg/m\^2 | Once each at baseline for all participants, and 6 months after for hypertension patient or 9 months after for diabetes patient (Total 2 times) |
Waist circumference in centimeter | Body measurement | Once each at baseline for all participants, and 6 months after for hypertension patient or 9 months after for diabetes patient (Total 2 times) |
Medication Adherence | Duration of Medication Use/Prescription Period | Once each at baseline for all participants, and 6 months after for hypertension patient or 9 months after for diabetes patient (Total 2 times) |
Costs of treatment (Healthcare expenditure) | Healthcare expenditure related to manage the designated disease | up to 6 months after for hypertension patient or 9 months after for diabetes patient |
Lifestyle questionnaire | We use questionnaire for assessing physical activity, smoking status and alcohol drinking. This questionnaire is based on Health checkup questionnaire for general health screening in Korea and Guideline for Primary Health Care Chronic Diseases Management Pilot Program(3rd Revision) in Korea. "In relation to physical activity, the assessment will include regular exercise habits, types of exercise, intensity of exercise, and the amount of exercise. Regarding alcohol consumption, current drinking status and drinking history will be evaluated. For smoking, lifelong smoking status, as well as current and past smoking history, will be confirmed. | Once each at baseline for all participants, and 6 months after for hypertension patient or 9 months after for diabetes patient (Total 2 times) |
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
接受健康志愿者
是
- Participation aged 18 to 70 years
- Participation diagnosed with diabetes (including borderline diabetes) or hypertension (including borderline hypertension)
However, we will exercise flexibility in age eligibility, allowing patients above 70 years to participate if they meet the following criteria:
Digital Literacy: Participants above 70 years must demonstrate proficiency in digital technology and the ability to effectively use the mobile application "Value Health," which has been specially developed for this research.
- Incompatible Mobile Device: Individuals using older mobile phones that are not compatible with the "Value of Health" application will be excluded.
- Participation in Concurrent Research: Individuals who are currently participating in another research program involving smart health technology will not be eligible for inclusion in our study.
- Non-Acceptance of Random Assignment or Participation: Individuals who do not agree to be randomly assigned to either the treatment or control group or who do not wish to engage in our research program will be excluded from participation.
首尔大学377 个活跃的临床试验可供探索- Korea Health Industry Development Institute
- 首尔大学377 个活跃的临床试验可供探索
研究中心联系人
联系人: Juho Choi, MD, 01072797401, [email protected]
联系人: Hee Jung Lee, BS, 01024687863, [email protected]
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