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Clinical Trials/NCT06759844
NCT06759844
Active, not recruiting
Not Applicable

A Randomized Controlled Clinical Study for Validating the Effectiveness of a Mobile Health Management Program Aimed At Colorectal Cancer Survivors with Comorbid Chronic Conditions

Seoul National University Hospital1 site in 1 country200 target enrollmentJanuary 1, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus
Sponsor
Seoul National University Hospital
Enrollment
200
Locations
1
Primary Endpoint
Fasting Blood Sugar
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
January 1, 2025
End Date
December 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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)

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Fasting Blood Sugar

Time Frame: From enrollment to the end of treatment at 3months

Check for decreased blood sugar levels

Hemoglobin A1c

Time Frame: From enrollment to the end of treatment at 3months

check if the level has decreased

Total Cholesterol

Time Frame: From enrollment to the end of treatment at 3months

Check if the level has decreased

LDL Cholesterol

Time Frame: From enrollment to the end of treatment at 3months

Check if the level has decreased

Systolic and Diastolic Blood Pressure

Time Frame: From enrollment to the end of treatment at 3months

Check if the level has decreased

Body Weight

Time Frame: From enrollment to the end of treatment at 3months

Check if the level has decreased

Body Mass Index

Time Frame: From enrollment to the end of treatment at 3months

Check if the level has decreased

Physical Activity Levels

Time Frame: From enrollment to the end of treatment at 3months

Check if the level has decreased

Secondary Outcomes

  • 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)

Study Sites (1)

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