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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07129915
Enrollment
250
Registered
2025-08-19
Start date
2025-11-01
Completion date
2026-06-30
Last updated
2025-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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).

Interventions

BEHAVIORALLinguistic Nudging Training

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

DEVICEMedication Preference App

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

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

Sponsors

Yunxuan Li
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Glycated Hemoglobin (HbA1c) LevelBaseline and Month 6Absolute 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 ScoreBaseline, Month 3, Month 6Composite 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) ScoreBaselinePatient-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.

Countries

China

Contacts

Primary ContactWei WANG, M.D.
wwei19742007@hotmail.com+8613939809540
Backup ContactYunxuan Li, Master Candidate
yunxuanli@stu.xmu.edu.cn+8613939809540

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026