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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE
Enrollment
113
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.
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
Cheng Gung Memorial Hospital
Linkou District, Taoyuan City,, Taiwan
Understanding the benefits and risks of complementary therapies (CTs) use scale
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.
Time frame: Pre-test (baseline),4,8,12 weeks after intervention
Patient empowerment
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.
Time frame: Pre-test (baseline),4,8,12 weeks after intervention
System Usability Scale (SUS)
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.
Time frame: Pre-test (baseline) and 12 weeks after intervention
Quality of life
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.
Time frame: Pre-test (baseline) and 12 weeks after intervention
Patient-HCP Communication
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.
Time frame: Pre-test (baseline) and 12 weeks after intervention
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