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NCT Number: NCT07129915

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

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).

Recruiting

Interested in participating?

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Physician-Patient Relations Self-management

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Linguistic Nudging Training

Behavioral

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

Medication Preference App

Device

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

Standard Diabetes Care

Other

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

Primary outcomes

  1. Change in Glycated Hemoglobin (HbA1c) Level

    Time frame: 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.

  2. Diabetes Self-Management Capacity Scale Score

    Time frame: 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.

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Wei WANG, M.D.

CONTACT

[email protected]

+8613939809540

Yunxuan Li, Master Candidate

CONTACT

[email protected]

+8613939809540

Sponsors and collaborators

Lead sponsor

Yunxuan Li

Other

Registry information

Official study title

Effect of Nudge-Based Shared Decision Making on Self-Management Among Patients With Type 2 Diabetes: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 19, 2025
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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