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临床试验/NCT07835061
NCT07835061进行中(未招募)不适用

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

Chang Gung University of Science and Technology1 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2026年8月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
113
试验地点
1
主要终点
Understanding the benefits and risks of complementary therapies (CTs) use scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

The process of keeping the study group assignment hidden after the allocation to participant, care provider, investigator, outcomes assessor

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

研究组 & 干预措施

Intervention 1

Experimental

AI-CIMCare Chatbot plus Empowerment Application for CAM Health Education

干预措施: AI-CIMCare Chatbot (Behavioral)

Intervention 1

Experimental

AI-CIMCare Chatbot plus Empowerment Application for CAM Health Education

干预措施: Empowerment Application for CAM Health Education (Behavioral)

Intervention 2

Active Comparator

Empowerment Application for CAM Health Education

干预措施: Empowerment Application for CAM Health Education (Behavioral)

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Patient empowerment(Pre-test (baseline),4,8,12 weeks after intervention)
  • System Usability Scale (SUS)(Pre-test (baseline) and 12 weeks after intervention)
  • Quality of life(Pre-test (baseline) and 12 weeks after intervention)
  • Patient-HCP Communication(Pre-test (baseline) and 12 weeks after intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hsiao-Yun Chang

professor

Chang Gung University of Science and Technology

研究点 (1)

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