DiabetesCAMNCT06317584
Empowerment-based Complementary and Alternative Medicine (ECAM)
A study testing Experimental: Empowerment Application for CAM Health Education and Written Paper for CAM Health Education in people with Diabetes, run by Chang Gung University of Science and Technology at 1 site in Taiwan.
Trial summary
This phase study will use a randomized trial method to evaluate the performance of the ECAM educational app in the promotion of CAM health literacy and communication among 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?
- Experimental: Empowerment Application for CAM Health Education and Written Paper for CAM Health Education
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 May 2024to 3 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Taoyuan City, Guishan District, 333
About this study
Official title: The Establishment of "Empowerment-based Complementary and Alternative Medicine (ECAM) " Educational Program to Improve Complementary and Alternative Medicine(CAM) Health Literacy in Patients With Diabetes: Dilemma Analysis, Integration Into Practice and Outcome Evaluation
This phase study will use a randomized trial method to evaluate the performance of the ECAM educational app in the promotion of CAM health literacy and communication among patients with diabetes.
Read the detailed description
The objectives of this phase study are to (1) implement the ECAM educational app to empower patients with diabetes in their management of diabetes alongside CAM use; (2) examine the impact of the ECAM educational app on patient empowerment, CAM health literacy, risk management of CAM use, CAM communication and diabetes quality of life in patients with diabetes; and (3) collect feedback from both patients and nurses on how to improve the ECAM educational app for dissemination and implementation.
- Conditions
- Diabetes
- Being tested
- Experimental: Empowerment Application for CAM Health Education, Written Paper for CAM Health Education
- Keywords
- Complementary and Alternative Medicine (CAM), 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.
Experimental: Empowerment Application for CAM Health EducationOther
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
Written Paper for CAM Health EducationOther
Using written paper for complementary and alternative therapy education and explaining the risk factors that need to be considered
| Study group | Role | What they receive |
|---|---|---|
| Empowerment Application for CAM Health Education. | Experimental | Using empowerment software applications for complementary and alternative therapy education, explaining the risk factors that need to be considered, and teaching the use of the assistive tool of the empowerment software application Receives: Other: Experimental: Empowerment Application for CAM Health Education |
| Written Paper for CAM Health Education. | Placebo comparator | Using written paper for complementary and alternative therapy education, explaining the risk factors that need to be considered Receives: Other: Written Paper for CAM Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Understanding the benefits-risks of complementary therapies (CTs) use scale Alternative Medicine (CAM) use questionnaire
Measure patients' understanding of benefit-risk management on CAM use，The lower the score, the poorer the understanding.
Measured: Pre-test (baseline), 2, 3 months after intervention
Quality of life questionnaire
assess patients' satisfaction with various aspects of life while managing diabetes.
Measured: Pre-test (baseline), 2, 3 months after intervention
Diabetes Empowerment scale
Measure patients' understanding of benefit-risk management on CAM use, the minimum and maximum values，and higher scores .The minimum is 10，maximum values is 40，The lower the score, the poorer the understanding.
Measured: Pre-test (baseline), 2, 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start17 May 2024
- Primary completion16 Aug 2024
- Study completion3 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomized trail method
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Chang Gung Memorial 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
- NCT06317584
- Sponsor's protocol ID
- NMRPF3M0042
- Acronym
- CAM
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2024
- Last updated
- 1 Apr 2025
- 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.
Publications
Chang HY, Yeh KC, Huang YY, Li JH, Liu FH. Empowering Patients Through Literacy: A Randomized Controlled Trial of an Educational App for Evaluating Complementary Therapies in Diabetes Management. Nurs Open. 2026 Jul;13(7):e70658. doi: 10.1002/nop2.70658.
PubMed 42361247
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Establishment of "Empowerment-based Complementary and Alternative Medicine (ECAM) " Educational Program to Improve Complementary and Alternative Medicine(CAM) Health Literacy in Patients With Diabetes: Dilemma Analysis, Integration Into Practice and Outcome Evaluation
- ClinicalTrials.gov ID
- NCT06317584
- Acronym / sponsor ID
- CAM / NMRPF3M0042
- Conditions
- Diabetes
- Keywords
- Complementary and Alternative Medicine (CAM), Patient Education, Empowerment, Health Literacy, Application, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Chang Gung University of Science and TechnologyUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Chang Gung Memorial Hospital
- Study start
- 17 May 2024 (actual)
- Primary completion
- 16 Aug 2024 (actual)
- Study completion
- 3 Jan 2025 (actual)
- First posted
- 19 Mar 2024 (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.
This phase study will use a randomized trial method to evaluate the performance of the ECAM educational app in the promotion of CAM health literacy and communication among patients with diabetes.
Detailed description
The objectives of this phase study are to (1) implement the ECAM educational app to empower patients with diabetes in their management of diabetes alongside CAM use; (2) examine the impact of the ECAM educational app on patient empowerment, CAM health literacy, risk management of CAM use, CAM communication and diabetes quality of life in patients with diabetes; and (3) collect feedback from both patients and nurses on how to improve the ECAM educational app 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
- Randomized trail method
| Arm | Type | Receives |
|---|---|---|
| Empowerment Application for CAM Health Education. | Experimental | Other: Experimental: Empowerment Application for CAM Health EducationUsing empowerment software applications for complementary and alternative therapy education, explaining the risk factors that need to be considered, and teaching the use of the assistive tool of the empowerment software application |
| Written Paper for CAM Health Education. | Placebo comparator | Other: Written Paper for CAM Health EducationUsing written paper for complementary and alternative therapy education, explaining the risk factors that need to be considered |
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 |
|---|---|---|
| Experimental: 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 | Other | Empowerment Application for CAM Health Education. |
| Written Paper for CAM Health EducationUsing written paper for complementary and alternative therapy education and explaining the risk factors that need to be considered | Other | Written Paper for CAM Health Education. |
Primary outcome
Understanding the benefits-risks of complementary therapies (CTs) use scale Alternative Medicine (CAM) use questionnaire
Time frame: Pre-test (baseline), 2, 3 months after intervention
Measure patients' understanding of benefit-risk management on CAM use，The lower the score, the poorer the understanding.
Quality of life questionnaire
Time frame: Pre-test (baseline), 2, 3 months after intervention
assess patients' satisfaction with various aspects of life while managing diabetes.
Diabetes Empowerment scale
Time frame: Pre-test (baseline), 2, 3 months after intervention
Measure patients' understanding of benefit-risk management on CAM use, the minimum and maximum values，and higher scores .The minimum is 10，maximum values is 40，The lower the score, the poorer the understanding.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Derived from this study: PubMed 42361247Chang HY, Yeh KC, Huang YY, Li JH, Liu FH. Empowering Patients Through Literacy: A Randomized Controlled Trial of an Educational App for Evaluating Complementary Therapies in Diabetes Management. Nurs Open. 2026 Jul;13(7):e70658. doi: 10.1002/nop2.70658.
- 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 Experimental: Empowerment Application for CAM Health Education and Written Paper 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: finished, as of the sponsor's last update on 1 Apr 2025. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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-risks of complementary therapies (CTs) use scale Alternative Medicine (CAM) use questionnaire (time frame: Pre-test (baseline), 2, 3 months after intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06317584, which also lists 1 linked publication.
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 1 Apr 2025; AzTrials last refreshed its copy on 3 Nov 2026.