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

NCT ID: NCT07129915

Last Updated: 2025-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-01

Study Completion Date

2026-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Linguistic Nudging Group

Receives communication training + preference app

Group Type EXPERIMENTAL

Linguistic Nudging Training

Intervention Type BEHAVIORAL

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

Medication Preference App

Intervention Type DEVICE

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

Standard Diabetes Care

Intervention Type OTHER

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

Standard Care Group

Receives routine diabetes management only

Group Type OTHER

Standard Diabetes Care

Intervention Type OTHER

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

Interventions

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Linguistic Nudging Training

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

Intervention Type BEHAVIORAL

Medication Preference App

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

Intervention Type DEVICE

Standard Diabetes Care

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yunxuan Li

OTHER

Sponsor Role lead

Responsible Party

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Yunxuan Li

Principal Investigator and Graduate Student Researcher, School of Medicine, Xiamen University

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Xiang'an Hospital Affiliated to Xiamen University

Xiamen, Fujian, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wei WANG, M.D.

Role: CONTACT

+8613939809540

Yunxuan Li, Master Candidate

Role: CONTACT

+8613939809540

Facility Contacts

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Yunxuan Li, Student

Role: primary

+8613939809540

Role: backup

Other Identifiers

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XAHLL2025049

Identifier Type: -

Identifier Source: org_study_id

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