Pilot RCT of a Chinese Medicine Diabetes Education Programme
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
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Yuen-Shan Ho, PhD
- 電話番号：852 2766 6410
- メール：janice.ys.ho@polyu.edu.hk
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：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.
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実験的：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.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Recruitment rate
時間枠：From start of recruitment to end of recruitment period
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Proportion of eligible individuals who provide informed consent and are randomised into the study.
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From start of recruitment to end of recruitment period
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Retention rate
時間枠：From randomisation to 2-month follow-up
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Proportion of randomised participants who complete the post-intervention assessment (T1) and the 2-month follow-up assessment (T2).
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From randomisation to 2-month follow-up
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Adherence to the education programme
時間枠：During the 4-week intervention period
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Proportion of participants in the intervention group who attend at least 3 out of the 4 scheduled education sessions.
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During the 4-week intervention period
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Acceptability of the programme
時間枠：At the end of the 4-week education programme
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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.
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At the end of the 4-week education programme
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Diabetes management self-efficacy
時間枠：Baseline, post-intervention (T1), and 2-month follow-up (T2)
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Measured by the Chinese version of the Diabetes Management Self-Efficacy Scale (C-DMSES).
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Baseline, post-intervention (T1), and 2-month follow-up (T2)
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Diabetes self-management behaviours
時間枠：Baseline, post-intervention (T1), and 2-month follow-up (T2)
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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.
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Baseline, post-intervention (T1), and 2-month follow-up (T2)
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Blood glucose level
時間枠：Baseline and 2-month follow-up (T2)
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Fasting blood glucose level, HbA1c
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Baseline and 2-month follow-up (T2)
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Blood lipid levels
時間枠：Baseline and 2-month follow-up (T2)
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Total cholesterol, triglycerides, HDL-C and LDL-C
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Baseline and 2-month follow-up (T2)
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Body mass index (BMI)
時間枠：Baseline, post-intervention (T1), and 2-month follow-up (T2)
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Calculated from measured height and weight.
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Baseline, post-intervention (T1), and 2-month follow-up (T2)
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Blood pressure
時間枠：Baseline, post-intervention (T1), and 2-month follow-up (T2)
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Systolic and diastolic blood pressure.
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Baseline, post-intervention (T1), and 2-month follow-up (T2)
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協力者と研究者
捜査官
- 主任研究者：Yuen-Shan Ho, PhD、The Hong Kong Polytechnic University
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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