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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Yuen-Shan Ho, PhD
- Número de teléfono: 852 2766 6410
- Correo electrónico: janice.ys.ho@polyu.edu.hk
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: 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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Experimental: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Recruitment rate
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Diabetes management self-efficacy
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Yuen-Shan Ho, PhD, The Hong Kong Polytechnic University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- P0046606
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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