DiabetesAI-CIMCareNCT07835061
AI-CIMCare Chatbot" to Enhance Complementary and Integrative Medicine (CIM)
A study testing AI-CIMCare Chatbot and Empowerment Application for CAM Health Education in people with Diabetes, run by Chang Gung University of Science and Technology at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Diabetes
- What is being tested?
- AI-CIMCare Chatbot and Empowerment Application for CAM Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Aug 2026to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participants will be excluded by an assistant researcher if they serious physical condition and hard of hearing and seeing.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Cheng Gung Memorial Hospital
Linkou District, Taoyuan City,, Guishan District 333
About this study
Official title: Impact Evaluation of the "AI-CIMCare Chatbot" to Enhance Complementary and Integrative Medicine (CIM) Health Literacy and Diabetes Management
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.
Read the detailed description
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.
- Conditions
- Diabetes
- Being tested
- AI-CIMCare Chatbot, Empowerment Application for CAM Health Education
- Keywords
- Complementary and Integrative Medicine (CIM), Patient Education, Empowerment, Health Literacy, Application, Diabetes
- Medical subject headings
- Diabetes Mellitus, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-CIMCare ChatbotBehavioural
Also called Empowerment Application for CAM
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.
Empowerment Application for CAM Health EducationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention 1 | Experimental | AI-CIMCare Chatbot plus Empowerment Application for CAM Health Education Receives: Behavioral: AI-CIMCare Chatbot; Behavioral: Empowerment Application for CAM Health Education |
| Intervention 2 | Active comparator | Empowerment Application for CAM Health Education Receives: Behavioral: Empowerment Application for CAM Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-test (baseline),4,8,12 weeks after intervention
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-test (baseline) and 12 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start5 Aug 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 113 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan, Chang Gung Memorial Hospital, Taoyuan General Hospital
- Responsible party
- Principal investigator, Hsiao-Yun Chang, Chang Gung University of Science and Technology
- Investigators
- Chang Hsiao Yun, PhD, Study chair, Chang Gung University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835061
- Sponsor's protocol ID
- NMRPF3Q0072
- Other IDs
- NMRPF3Q0072
- Acronym
- AI-CIMCare
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Evaluation of the "AI-CIMCare Chatbot" to Enhance Complementary and Integrative Medicine (CIM) Health Literacy and Diabetes Management
- ClinicalTrials.gov ID
- NCT07835061
- Acronym / sponsor ID
- AI-CIMCare / NMRPF3Q0072
- Conditions
- Diabetes
- Keywords
- Complementary and Integrative Medicine (CIM), Patient Education, Empowerment, Health Literacy, Application, Diabetes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 113 participants (estimated)
- Lead sponsor
- Chang Gung University of Science and TechnologyUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan, Chang Gung Memorial Hospital, Taoyuan General Hospital
- Study start
- 5 Aug 2026 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental study
| Arm | Type | Receives |
|---|---|---|
| Intervention 1 | Experimental | Behavioral: AI-CIMCare Chatbot, Behavioral: Empowerment Application for CAM Health EducationAI-CIMCare Chatbot plus Empowerment Application for CAM Health Education |
| Intervention 2 | Active comparator | Behavioral: Empowerment Application for CAM Health EducationEmpowerment Application for CAM Health Education |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Participants will be excluded by an assistant researcher if they serious physical condition and hard of hearing and seeing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-CIMCare ChatbotAlso: Empowerment Application for CAMThe 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. | Behavioural | Intervention 1 |
| Empowerment Application for CAM Health EducationUsing 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 | Behavioural | Intervention 1, Intervention 2 |
Primary outcome
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.
4 secondary outcomes
Patient empowerment
Time frame: Pre-test (baseline),4,8,12 weeks after intervention
System Usability Scale (SUS)
Time frame: Pre-test (baseline) and 12 weeks after intervention
Quality of life
Time frame: Pre-test (baseline) and 12 weeks after intervention
Patient-HCP Communication
Time frame: Pre-test (baseline) and 12 weeks after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chang Hsiao Yun, PhD study chair
Chang Gung University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-CIMCare Chatbot and Empowerment Application for CAM Health Education in people with Diabetes, run by Chang Gung University of Science and Technology at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Understanding the benefits and risks of complementary therapies (CTs) use scale (time frame: Pre-test (baseline),4,8,12 weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.