Nudge-Based Shared Decision Making and Self-Management in Type 2 Diabetes: A Randomized Trial

Yunxuan Li250 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

250

Conditions

Interventions

Linguistic Nudging TrainingBEHAVIORAL

Physicians receive 4-hour communication training to optimize shared decision-making using behavioral nudging techniques

Medication Preference AppDEVICE

Patients use WeChat-based mini-program to record daily medication preferences and concerns

Standard Diabetes CareOTHER

Routine follow-up visits, HbA1c monitoring, and basic health education per hospital protocol

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Outcomes

Primary Outcomes

Change in Glycated Hemoglobin (HbA1c) Level

Absolute change in HbA1c (%) from baseline to 6 months, measured by high-performance liquid chromatography (HPLC). Reflects average blood glucose control over 3 months.

Time frame: Baseline and Month 6

Diabetes Self-Management Capacity Scale Score

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.

Time frame: Baseline, Month 3, Month 6

Shared Decision Making Questionnaire (SDM-Q-9) Score

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.

Time frame: Baseline