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NCT Number: NCT07835061

AI-CIMCare Chatbot" to Enhance Complementary and Integrative Medicine (CIM)

Performance analysis of the AI-CIMCare Chatbot is an essential way to ensure its impact on the promotion of patient-based outcomes in patients with diabetes.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Diabetes Behavior Diabetes Mellitus Empowerment Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Social Behavior

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cheng Gung Memorial Hospital

Linkou District, Taoyuan City,, Guishan District 333, Taiwan

About this study

A randomized controlled trial is to determine a cause-effect relation which exists between the intervention and the outcomes by avoiding contamination across individuals (Polit & Beck, 2022). The chatbot for patients with diabetes in the management of CIM use alongside conventional diabetes treatment will be trained well at the end of the phase II study. The objectives of this phase are to (1) implement the chatbot to empower patients with diabetes in their management of diabetes alongside CAM use, (2) examine the impact of the chatbot on CIM health literacy, patient empowerment, user engagement, clinical outcomes and facilitate communication with HCPs in patients with diabetes, and (3) collect feedback from patients on how to improve the chatbot for dissemination and implementation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • People over the age of 20
  • diagnosis of diabetes at least 12 months before the interview; and
  • The use of CAM at least 3 months
  • Sufficient mental ability to understand the informed consent form and sign it.

Exclusion criteria

  • Participants will be excluded by an assistant researcher if they serious physical condition and hard of hearing and seeing.

Treatment and study plan

AI-CIMCare Chatbot

Behavioral

The intervention will be carried out over a 12-week period, which contains four sections: (1) knowledge on benefit-risk assessment of CIM use; (2) short videos regarding information and skills necessary to seek, assess; (3) evaluate how to be critical for wise and safe use of CIM; and (4) linkage of government websites and the decision-making algorithm on the Benefit-Risk Assessment of CIM Use for People with Diabetes.

Other names: Empowerment Application for CAM

Empowerment Application for CAM Health Education

Behavioral

Using empowerment software application for complementary and alternative therapy education, explaining the risk factors that need to be considered, and teaching the use of assistive tool of the empowerment software application

Primary outcomes

  1. Understanding the benefits and risks of complementary therapies (CTs) use scale

    Time frame: Pre-test (baseline),4,8,12 weeks after intervention

    The 15-item scale assesses patients' awareness of CIM use in diabetes. The maximum score is 4 points, and the minimum score is 1 point for each item. Scores range from 15-60, with higher scores indicating greater understanding.

Secondary outcomes

  1. Patient empowerment

    Time frame: Pre-test (baseline),4,8,12 weeks after intervention

    The 10-item Diabetes Empowerment Scale assesses patients' perceived control and readiness for diabetes self-management. Maximum score is 4 points, minimum score is 1 point for each item. Scores range from 10-50, with higher scores indicating greater empowerment. The scale showed acceptable reliability (α = .77) and established construct and criterion validity.

  2. System Usability Scale (SUS)

    Time frame: Pre-test (baseline) and 12 weeks after intervention

    The 10-item questionnaire measures how easy a product, system, or website is to use. The maximum score is 5 points, and the minimum is 1 point per item. Scores range from 10-50, with higher scores indicating greater usability.

  3. Quality of life

    Time frame: Pre-test (baseline) and 12 weeks after intervention

    The 15-item quality-of-life measure for Chinese patients with diabetes will be used to assess their life satisfaction. The maximum score is 5 points, and the minimum score is 1 point. Scores range from 15-75, with higher scores indicating greater life satisfaction.

  4. Patient-HCP Communication

    Time frame: Pre-test (baseline) and 12 weeks after intervention

    The 10-item Details of CIM Use Survey, designed by Chang et al. (2011) with good content validity, assesses patterns of CIM use, experiences of CIM use, and disclosure of CIM use to HCPs.

Other outcomes

  1. Glycated Hemoglobin blood test

    Time frame: Pre-test (baseline) and 12 weeks after intervention

    It measures the average blood sugar levels over the past two to three months. Unit of Measurement: Percentage (%).

  2. Fasting Plasma Glucose blood test

    Time frame: Pre-test (baseline) and 12 weeks after intervention

    A patient has fasted (no food or drink except water) for at least 8 hours to measure baseline blood sugar levels. Unit of Measurement: mg/dL (milligrams per deciliter)

  3. Cholesterol blood test

    Time frame: Pre-test (baseline) and 12 weeks after intervention

    It measures the weight of cholesterol in milligrams per deciliter of blood. Unit of Measurement: Unit of Measurement: mg/dL (milligrams per deciliter)

  4. Triglycerides blood test

    Time frame: Pre-test (baseline) and 12 weeks after intervention

    It measures serum or plasma triglyceride concentration. Unit of Measurement: mg/dL (milligrams per deciliter)

  5. Aspartate aminotransferase (AST) blood test

    Time frame: Pre-test (baseline) and 12 weeks after intervention

    It helps determine liver function. Unit of Measurement: units per liter (U/L).

  6. Alanine aminotransferase (ALT) blood test

    Time frame: Pre-test (baseline) and 12 weeks after intervention

    It helps determine liver function. Unit of Measurement: units per liter (U/L).

  7. Blood urea nitrogen (BUN) blood test

    Time frame: Pre-test (baseline) and 12 weeks after intervention

    It measures kidney filtration of protein waste. Unit of Measurement: milligrams per deciliter (mg/dL)

  8. Creatinine (Cr) blood test

    Time frame: Pre-test (baseline) and 12 weeks after intervention

    It measures how well the kidneys. Unit of Measurement: mg/dL (milligrams per deciliter)

  9. estimated GFR (eGFR) test

    Time frame: Pre-test (baseline) and 12 weeks after intervention

    It measures the volume of blood (in milliliters) filtered by the kidneys each minute. Unit of Measurement: milliliters per minute adjusted for body surface area mL/min/1.73m²

  10. Albumin-to-Creatinine Ratio (ACR) Urinalysis

    Time frame: Pre-test (baseline) and 12 weeks after intervention

    It is reported in milligrams per millimole (mg/mmol) or milligrams per gram (mg/g)

Sponsors and collaborators

Lead sponsor

Chang Gung University of Science and Technology

Other

Collaborators

  • Chang Gung Memorial Hospital
  • National Science and Technology Council, Taiwan
  • Taoyuan General Hospital

Registry information

Official study title

Impact Evaluation of the "AI-CIMCare Chatbot" to Enhance Complementary and Integrative Medicine (CIM) Health Literacy and Diabetes Management

Acronym: AI-CIMCare

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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