Effect of Nudge-Based Shared Decision Making on Self-Management Among Patients With Type 2 Diabetes: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Change in Glycated Hemoglobin (HbA1c) Level
研究概览
简要总结
This study aims to test whether a communication strategy called "linguistic nudging" can help doctors and patients with type 2 diabetes make better treatment decisions together, and whether this improves patients' ability to manage their condition.
What will happen in the study? - 250 adults with type 2 diabetes from Xiang'an Hospital (Xiamen) will be randomly assigned to one of two groups:
Intervention group:Doctors will receive special training in "linguistic nudging" techniques to encourage shared decision-making. Patients will use a mobile app to record medication preferences, and doctors will adjust advice based on these preferences.
Control group:Patients will receive standard diabetes care without these additional strategies.
- All participants will be followed for 6 months.
What is the study aiming to find out?
The main goal is to see if patients in the intervention group:
Better follow medication plans Improve blood sugar monitoring Have better blood sugar control Feel more satisfied with doctor-patient communication
Why is this important? Good self-management is key to controlling diabetes, but many patients struggle with it. Effective communication during shared decision-making may empower patients to manage their condition day-to-day with greater confidence.
Patient safety and rights:
Participation is completely voluntary All personal information will be kept strictly confidential Medical support will be provided if any health problems occur during the study Participants may withdraw at any time
This research has been approved by the Ethics Committee of Xiang'an Hospital (Approval date: October 2025).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Confirmed diagnosis of type 2 diabetes
- •Age ≥ 18 years
- •Normal cognitive function (assessed by Mini-Cog score ≥ 3)
- •Basic smartphone operation ability (can independently use WeChat)
- •Willing to participate and sign informed consent
排除标准
- •Severe acute complications (e.g., ketoacidosis, hyperosmolar coma)
- •Documented cognitive impairment (dementia, Alzheimer's, etc.)
- •Currently participating in other clinical trials
- •Life expectancy < 6 months
- •Pregnancy or lactation
研究组 & 干预措施
Linguistic Nudging Group
Receives communication training + preference app
干预措施: Linguistic Nudging Training (Behavioral)
Linguistic Nudging Group
Receives communication training + preference app
干预措施: Medication Preference App (Device)
Linguistic Nudging Group
Receives communication training + preference app
干预措施: Standard Diabetes Care (Other)
Standard Care Group
Receives routine diabetes management only
干预措施: Standard Diabetes Care (Other)
结局指标
主要结局
Change in Glycated Hemoglobin (HbA1c) Level
时间窗: Baseline and Month 6
Absolute change in HbA1c (%) from baseline to 6 months, measured by high-performance liquid chromatography (HPLC). Reflects average blood glucose control over 3 months.
Diabetes Self-Management Capacity Scale Score
时间窗: Baseline, Month 3, Month 6
Composite score (0-100) based on validated 20-item scale assessing medication adherence, dietary control, physical activity, and blood glucose monitoring. Higher scores indicate better self-management capacity.
Shared Decision Making Questionnaire (SDM-Q-9) Score
时间窗: Baseline
Patient-reported evaluation of shared decision quality using 9-item Likert scale (0-45). Assesses physician-patient collaboration in treatment choices. Higher scores indicate better shared decision-making.
次要结局
未报告次要终点
研究者
Yunxuan Li
Principal Investigator and Graduate Student Researcher, School of Medicine, Xiamen University
Xiamen University