Development and Pilot Implementation of a Shared Decision-Making Intervention for Type 2 Diabetes Using the Ottawa Framework
23 de agosto de 2026 atualizado por: Chen Lili, Anhui Medical University
Construction and Preliminary Application of a Shared Decision-Making Intervention Program for Patients With Type 2 Diabetes Based on the Ottawa Decision Support Framework
The goal of this clinical trial is to evaluate the effectiveness of a shared decision-making (SDM) intervention program based on the Ottawa Decision Support Framework in adult patients with type 2 diabetes (aged ≥18 years, without severe complications). The main questions it aims to answer are:
- Does the intervention improve patients' decisional self-efficacy compared to usual care?
- Does the intervention enhance patients' actual participation in treatment decision-making?
- Does the intervention reduce diabetes-related distress?
- Does the intervention improve diabetes self-management behaviors? Researchers will compare the intervention group (receiving the SDM intervention plus usual care) with the control group (receiving usual care only) to see if the intervention leads to significantly better outcomes in decision self-efficacy, decision participation, diabetes distress, and self-management.
Participants will:
- Receive a Question Prompt List (QPL) handbook and be guided by a nurse to mark their most concerning questions.
- Attend face-to-face educational sessions covering disease basics, medication comparisons, lifestyle adjustments, and complication prevention.
- Engage in shared decision-making discussions with physicians, nurses, and family members to co-develop a personalized treatment plan.
- Complete follow-up assessments at 4 weeks and 6 weeks after discharge via telephone or outpatient visit, including questionnaires on decision participation, self-efficacy, satisfaction, diabetes distress, and self-management behaviors.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
70
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Lili Chen
- Número de telefone: +86 13045512663
- E-mail: chen20180524@163.com
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion criteria:
- Diagnosed with type 2 diabetes mellitus according to the diagnostic criteria established by the Chinese Diabetes Society.
- Aged 18 years or older.
- Conscious, able to communicate normally, and capable of reading and completing questionnaires independently or with assistance.
- Informed consent obtained and voluntary participation.
Exclusion criteria:
- Complicated with severe acute or chronic complications of diabetes (e.g., diabetic ketoacidosis, severe diabetic nephropathy, proliferative retinopathy, etc.).
- Complicated with severe heart, liver, kidney, or other organ dysfunction, or malignant tumors.
- With cognitive impairment, mental disorders, or communication disorders.
- Currently participating in other interventional clinical studies.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Sem intervenção: Grupo de controle
|
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Outro: Grupo de intervenção
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This intervention is a shared decision-making (SDM) program for adults with type 2 diabetes, guided by the Ottawa Decision Support Framework.
It consists of three phases: (1) Assess decision needs - build trust, introduce SDM, distribute a Question Prompt List (QPL) handbook, and let patients mark their top concerns; also collect baseline data using validated scales.
(2) Provide decision support - doctors explain current status and treatment options; nurses give education on diet, exercise, medication, and complications; then together with family, patients make a personalized treatment plan.
(3) Evaluate outcomes - before discharge, confirm skills and address remaining doubts; follow up at weeks 4 and 6 via phone/clinic to reassess decision self-efficacy, participation, diabetes distress, self-management, and glycemic control.
The control group receives usual care only.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Actual participation in treatment decision-making
Prazo: From enrollment to the end of treatment at 6 weeks
|
Measured by the Control Preferences Scale (CPS) , originally developed by Lauri et al. and translated into Chinese by Ma Lili (2004).
The scale consists of two parts: attitude toward participation in treatment decision-making and actual participation in treatment decision-making.
This study uses the part measuring actual participation.
The Chinese version has a content validity index of 0.890 and a Cronbach's α coefficient of 0.851 for the actual participation subscale.
The 12 items reflect the shared decision-making process: items 1, 6, 7, 8, 9 assess weighing pros and cons; item 5 assesses providing information; items 2, 3, 4 assess expressing preferences; items 10, 11, 12 assess final decision-making.
Scoring details follow the standard CPS protocol.
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From enrollment to the end of treatment at 6 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Diabetes-related distress
Prazo: From enrollment to the end of treatment at 6 weeks.
|
Diabetes-related distress measured by the Chinese version of the Diabetes Distress Scale (DDS), translated and revised by Yang Qing et al. (2010).
The scale contains 17 items across 4 dimensions: emotional burden (5 items: 1,3,8,11,14), physician-related distress (4 items: 2,4,9,15), regimen-related distress (5 items: 5,6,10,12,16), and interpersonal distress (3 items: 7,13,17).
Each item uses a 6-point Likert scale (1=no problem, 6=very serious problem).
Scoring criteria: mean dimension/item score <2 = no distress, 2-3 = moderate distress, >3 = severe distress.
Cronbach's α=0.9515.
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From enrollment to the end of treatment at 6 weeks.
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Diabetes self-management behaviors
Prazo: From enrollment to the end of treatment at 6 weeks.
|
Diabetes self-management behaviors measured by the Summary of Diabetes Self-Care Activities (SDSCA) scale developed by Toobert et al., Chinese version translated by Sun Shengnan et al.
The scale contains 13 items across 6 dimensions: general diet (4 items), exercise (2 items), blood glucose monitoring (2 items), foot care (2 items), medication adherence (2 items), and smoking status (1 item).
Total score is the sum of all dimension scores, with higher scores indicating better self-management behaviors.
Cronbach's α for each dimension ranges from 0.62 to 0.92.
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From enrollment to the end of treatment at 6 weeks.
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Glycemic control
Prazo: From enrollment to the end of treatment at 6 weeks.
|
Glycemic control assessed by two complementary indicators: (1) Fasting blood glucose (FBG, mmol/L) - venous blood samples collected after an 8-hour overnight fast, analyzed using the glucose oxidase method, reflecting short-term glycemic status; (2) Glycosylated hemoglobin (HbA1c, %) - venous blood samples analyzed by high-performance liquid chromatography (HPLC), reflecting average blood glucose levels over the preceding 2-3 months.
Lower values of both indicators indicate better glycemic control.
According to Chinese Diabetes Society guidelines, target FBG is 4.4-7.0
mmol/L and target HbA1c is <7.0% for most non-pregnant adults with type 2 diabetes.
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From enrollment to the end of treatment at 6 weeks.
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Satisfaction with decision-making
Prazo: From enrollment to the end of treatment at 6 weeks.
|
Decision-making satisfaction measured by the Satisfaction with Decision (SWD) scale adapted by Xu Xiaolin (2010).
The scale contains 4 dimensions: information, communication and negotiation, decision-making, satisfaction and confidence.
It demonstrates good reliability and validity, with a Cronbach's α coefficient of 0.899.
Higher scores indicate greater satisfaction with medical decision-making participation.
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From enrollment to the end of treatment at 6 weeks.
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
27 de agosto de 2026
Conclusão Primária (Estimado)
20 de setembro de 2026
Conclusão do estudo (Estimado)
31 de outubro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
20 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
23 de agosto de 2026
Primeira postagem (Real)
25 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
25 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
23 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 81250921
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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