A Randomized Controlled Clinical Study for Validating the Effectiveness of a Mobile Health Management Program Aimed At Colorectal Cancer Survivors with Comorbid Chronic Conditions
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Fasting Blood Sugar
研究概览
简要总结
The goal of this clinical trial is to evaluate if a mobile health management program can improve chronic disease management among colorectal cancer survivors with comorbid conditions such as hypertension, diabetes, and dyslipidemia. The main questions it aims to answer are:
Does the mobile health application improve clinical outcomes such as blood pressure, blood glucose levels, and lipid profiles? Does the application enhance participants' health behaviors and self-management capabilities? Researchers will compare the mobile health application group to the educational booklet group to see if the digital intervention leads to better health outcomes and adherence to lifestyle changes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 19 years or older Colorectal cancer survivors (patients within 5 years of completion of curative treatments such as surgery, radiation therapy, or chemotherapy) who also have chronic conditions (hypertension, dyslipidemia, or diabetes)
- •Specific registration criteria:
- •Diabetes: Fasting blood sugar (FBS) ≥ 126 mg/dL or HbA1c ≥ 6.5% Dyslipidemia: Low-density lipoprotein cholesterol (LDL) ≥ 130 mg/dL Hypertension: Systolic blood pressure (SBP) ≥ 140 mmHg or Diastolic blood pressure (DBP) ≥ 90 mmHg Individuals who understand the purpose of this study and provide informed consent to participate Individuals who own and use a smartphone (able to use an ICT-based health management program)
排除标准
- •Individuals who are unable to speak, listen, or read in Korean Individuals determined by a physician to be physically or mentally unfit (e.g., shortness of breath, severe depression) to participate in the study Individuals who are deemed unable to use the ICT-based program
研究组 & 干预措施
Educational Booklet
Basic content on chronic disease management is provided. The content includes a basic booklet on managing chronic diseases without specific strategies. It covers topics like maintaining a positive mindset, managing stress, and exercising.
干预措施: Educational Booklet (Behavioral)
Mobile Health Application
Participants in this arm will use a mobile health application designed for colorectal cancer survivors with comorbid chronic conditions. The application provides daily educational content, goal-setting features, and self-monitoring tools to promote healthy behaviors. It includes modules on exercise, dietary management, and adherence to a personalized health plan. Participants will use the app daily for 3 months, with weekly progress evaluations and feedback provided through the application interface.
干预措施: Mobile Health Application (Behavioral)
结局指标
主要结局
Fasting Blood Sugar
时间窗: From enrollment to the end of treatment at 3months
Check for decreased blood sugar levels
Hemoglobin A1c
时间窗: From enrollment to the end of treatment at 3months
check if the level has decreased
Total Cholesterol
时间窗: From enrollment to the end of treatment at 3months
Check if the level has decreased
LDL Cholesterol
时间窗: From enrollment to the end of treatment at 3months
Check if the level has decreased
Systolic and Diastolic Blood Pressure
时间窗: From enrollment to the end of treatment at 3months
Check if the level has decreased
Body Weight
时间窗: From enrollment to the end of treatment at 3months
Check if the level has decreased
Body Mass Index
时间窗: From enrollment to the end of treatment at 3months
Check if the level has decreased
Physical Activity Levels
时间窗: From enrollment to the end of treatment at 3months
Check if the level has decreased
次要结局
- Improvement in Health Management Capability(From enrollment to the end of treatment at 3months)
- Increase in Health Behavior Patterns(From enrollment to the end of treatment at 3months)
- Emotional and Subjective Health Status(From enrollment to the end of treatment at 3months)