Diabetes (DM), Medicine, Chinese Traditional
Conditions
Keywords
Diabetes Mellitus, patient education, self-management, medicine, chinese traditional
Brief 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.
Detailed description
This pilot randomised controlled trial evaluates the feasibility, acceptability and preliminary effects of a Chinese medicine diabetes education programme for adults with type 2 diabetes in Hong Kong. While Western-medicine-based diabetes education is well established locally, systematic and interactive Chinese medicine education remains limited. The programme integrates Chinese medicine concepts (body constitution, pattern differentiation, dietary therapy, emotional regulation, acupressure and lifestyle advice) with modern self-management principles. Content was refined through literature review, patient input and Delphi consensus. Forty adults with type 2 diabetes will be randomly allocated (1:1) to either a 4-week group education programme (four sessions, total 4-6 hours) or usual care. The control group will be offered the programme after final follow-up. Participants and facilitators are not blinded due to the nature of the educational intervention; outcome assessors will remain blinded to group allocation. Primary aims are to assess feasibility (recruitment, retention, adherence) and acceptability. Exploratory outcomes, measured at baseline, post-intervention and 2-month follow-up, include diabetes management self-efficacy (Chinese version of the Diabetes Management Self-Efficacy Scale, C-DMSES; Wu et al., 2008), self-management behaviours, blood glucose, lipids, BMI and blood pressure. Focus group interviews will gather qualitative feedback.
Interventions
BEHAVIORALChinese Medicine Diabetes Education Programme
A structured 4-week group education programme (four sessions, total contact time 4-6 hours) that integrates Chinese medicine concepts (body constitution, pattern differentiation, dietary therapy, emotional regulation, acupressure, and lifestyle advice) with modern diabetes self-management education.
Sponsors
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | From start of recruitment to end of recruitment period | Proportion of eligible individuals who provide informed consent and are randomised into the study. |
| Retention rate | From randomisation to 2-month follow-up | Proportion of randomised participants who complete the post-intervention assessment (T1) and the 2-month follow-up assessment (T2). |
| Adherence to the education programme | During the 4-week intervention period | Proportion of participants in the intervention group who attend at least 3 out of the 4 scheduled education sessions. |
| Acceptability of the programme | At the end of the 4-week education programme | Participant-reported acceptability and satisfaction with the Chinese medicine diabetes education programme, assessed by a structured questionnaire at the end of the programme. Additional qualitative feedback will be collected through focus group interviews at 2-month follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes management self-efficacy | Baseline, post-intervention (T1), and 2-month follow-up (T2) | Measured by the Chinese version of the Diabetes Management Self-Efficacy Scale (C-DMSES). |
| Diabetes self-management behaviours | Baseline, post-intervention (T1), and 2-month follow-up (T2) | Self-reported diabetes self-management behaviours, assessed using a participant logbook recording the frequency of exercise, acupressure, blood glucose monitoring and other self-care activities. |
| Blood glucose level | Baseline and 2-month follow-up (T2) | Fasting blood glucose level, HbA1c |
| Blood lipid levels | Baseline and 2-month follow-up (T2) | Total cholesterol, triglycerides, HDL-C and LDL-C |
| Body mass index (BMI) | Baseline, post-intervention (T1), and 2-month follow-up (T2) | Calculated from measured height and weight. |
| Blood pressure | Baseline, post-intervention (T1), and 2-month follow-up (T2) | Systolic and diastolic blood pressure. |
Contacts
CONTACTYuen-Shan Ho, PhD
PRINCIPAL_INVESTIGATORYuen-Shan Ho, PhD
The Hong Kong Polytechnic University
Outcome results
None listed