Development and Pilot Implementation of a Shared Decision-Making Intervention for Type 2 Diabetes Using the Ottawa Framework
2026年8月23日 更新者：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.
研究概览
研究类型
介入性
注册 (估计的)
70
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Lili Chen
- 电话号码：+86 13045512663
- 邮箱：chen20180524@163.com
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：控制组
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其他：干预组
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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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Actual participation in treatment decision-making
大体时间：From enrollment to the end of treatment at 6 weeks
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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
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Diabetes-related distress
大体时间：From enrollment to the end of treatment at 6 weeks.
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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
大体时间：From enrollment to the end of treatment at 6 weeks.
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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
大体时间：From enrollment to the end of treatment at 6 weeks.
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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
大体时间：From enrollment to the end of treatment at 6 weeks.
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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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月27日
初级完成 (估计的)
2026年9月20日
研究完成 (估计的)
2026年10月31日
研究注册日期
首次提交
2026年8月20日
首先提交符合 QC 标准的
2026年8月23日
首次发布 (实际的)
2026年8月25日
研究记录更新
最后更新发布 (实际的)
2026年8月25日
上次提交的符合 QC 标准的更新
2026年8月23日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.