Pilot RCT of a Chinese Medicine Diabetes Education Programme
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Hong Kong Polytechnic University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Chinese Medicine Diabetes Education Programme
BehavioralA 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Usual CareNo intervention 0 interventions
Group B: Chinese Medicine Diabetes Education ProgrammeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment rate
Proportion of eligible individuals who provide informed consent and are randomised into the study.
Time frame
From start of recruitment to end of recruitment period2
Retention rate
Proportion of randomised participants who complete the post-intervention assessment (T1) and the 2-month follow-up assessment (T2).
Time frame
From randomisation to 2-month follow-up3
Adherence to the education programme
Proportion of participants in the intervention group who attend at least 3 out of the 4 scheduled education sessions.
Time frame
During the 4-week intervention period4
Acceptability of the 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.
Time frame
At the end of the 4-week education programmeSecondary outcomes
1
Diabetes management self-efficacy
Measured by the Chinese version of the Diabetes Management Self-Efficacy Scale (C-DMSES).
Time frame
Baseline, post-intervention (T1), and 2-month follow-up (T2)2
Diabetes self-management behaviours
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.
Time frame
Baseline, post-intervention (T1), and 2-month follow-up (T2)3
Blood glucose level
Fasting blood glucose level, HbA1c
Time frame
Baseline and 2-month follow-up (T2)4
Blood lipid levels
Total cholesterol, triglycerides, HDL-C and LDL-C
Time frame
Baseline and 2-month follow-up (T2)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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