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NCT07758413
Pilot RCT of a Chinese Medicine Diabetes Education Programme
Conditions: Diabetes (DM), Medicine, Chinese Traditional
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: The Hong Kong Polytechnic University
Summary
The goal of this clinical trial is to learn if a Chinese medicine diabetes education programme is feasible and acceptable, and to explore its preliminary effects on self-management, for adults with type 2 diabetes in Hong Kong. The main questions it aims to answer are:
1. Is the Chinese medicine diabetes education programme feasible to deliver in a community setting (recruitment, retention and adherence)?
2. Is the programme acceptable to participants?
3. Does the programme show early signals of improving diabetes management self-efficacy and related outcomes?
Researchers will compare the Chinese medicine education programme to usual care to see if the programme is feasible, acceptable and shows preliminary benefits.
Participants will:
1. Be randomly assigned to either a 4-week Chinese medicine diabetes education programme (four group sessions, total 4-6 hours) or usual care
2. Complete assessments at baseline, after the programme, and at 2-month follow-up.
3. Attend a focus group interview at the end of the study (selected participants)
Outcome assessors will be blinded to group allocation.
Eligibility Criteria
Inclusion Criteria:
* Adults aged 18 years or above
* Diagnosed with type 2 diabetes mellitus
* Able to understand and communicate in Cantonese, and able to read Chinese
* Willing and able to provide written informed consent
* Able to attend the education sessions at the designated venues
Exclusion Criteria:
* Severe cognitive impairment that would prevent meaningful participation in group education
* Acute or unstable medical conditions, or serious chronic illnesses currently under active treatment (e.g., ongoing cancer treatment), that may preclude safe participation in group activities
* Currently participating in another structured diabetes education research programme
* Pregnancy
Source: ClinicalTrials.gov (NCT07758413). StuddyBuddy aggregates publicly available trial information.