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

NCT07129915 | Recruiting

• 1 other identifier: XAHLL2025049
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Diabetes Mellitus, Type 2; Physician-Patient Relations; Self-management

Keywords

Linguistic Nudging; Shared Decision Making; Randomized Controlled Trial; Mobile Health Application; Chinese Population

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline

Study Arms (2)

Linguistic Nudging Group

EXPERIMENTAL

Receives communication training + preference app

Behavioral: Linguistic Nudging Training; Device: Medication Preference App; Other: Standard Diabetes Care

Standard Care Group

OTHER

Receives routine diabetes management only

Other: Standard Diabetes Care

Interventions

Linguistic Nudging Training BEHAVIORAL

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

Linguistic Nudging Group

Medication Preference App DEVICE

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

Linguistic Nudging Group

Standard Diabetes Care OTHER

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

Linguistic Nudging Group; Standard Care Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yunxuan Li: lead

Study Sites (1)

Xiang'an Hospital Affiliated to Xiamen University

Xiamen, Fujian, 0592361101, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Wei WANG, M.D.

CONTACT

+8613939809540; wwei19742007@hotmail.com

Yunxuan Li, Master Candidate

CONTACT

+8613939809540; yunxuanli@stu.xmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator and Graduate Student Researcher, School of Medicine, Xiamen University

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 19, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)