Development and Pilot Test of a Chinese Medicine Diabetes Education Program 中醫糖尿病個人管理教育方案建構及初步試驗
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Recruitment rate
研究概览
简要总结
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:
- Is the Chinese medicine diabetes education programme feasible to deliver in a community setting (recruitment, retention and adherence)?
- Is the programme acceptable to participants?
- 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:
- Be randomly assigned to either a 4-week Chinese medicine diabetes education programme (four group sessions, total 4-6 hours) or usual care
- Complete assessments at baseline, after the programme, and at 2-month follow-up.
- Attend a focus group interview at the end of the study (selected participants)
Outcome assessors will be blinded to group allocation.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Usual Care
Participants will continue their usual medical care and any existing diabetes education or support. No additional structured Chinese medicine diabetes education programme will be provided during the study. After the final follow-up, they will be offered the same education programme.
Chinese Medicine Diabetes Education Programme
Participants will receive a 4-week Chinese medicine diabetes education programme consisting of four weekly group sessions (total 4-6 hours). Content includes Chinese medicine concepts of diabetes, body constitution, diet, emotional regulation, acupressure, skin and foot care, and physical activity.
干预措施: Chinese Medicine Diabetes Education Programme (Behavioral)
结局指标
主要结局
Recruitment rate
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Diabetes management self-efficacy(Baseline, post-intervention (T1), and 2-month follow-up (T2))
- Diabetes self-management behaviours(Baseline, post-intervention (T1), and 2-month follow-up (T2))
- Blood glucose level(Baseline and 2-month follow-up (T2))
- Blood lipid levels(Baseline and 2-month follow-up (T2))
- Body mass index (BMI)(Baseline, post-intervention (T1), and 2-month follow-up (T2))
- Blood pressure(Baseline, post-intervention (T1), and 2-month follow-up (T2))
研究者
HO Janice Yuen-Shan
Associate Professor
The Hong Kong Polytechnic University