Diabetic Patients,Self-Efficacy,Self-Care Behaviors,Artificial Intelligence-Based

NCT ID: NCT06985680

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2025-02-18

Brief Summary

This study employed an experimental research design using a randomized controlled trial methodology. Group allocation was performed randomly by generating serial numbers through a computer. Participants were then randomly assigned to either the experimental or control group by placing the serial numbers into opaque envelopes and selecting envelopes in random order as patients arrived for appointments.

The experimental group received conventional face-to-face education in addition to participating in the "Diabetes Smart Assistant" Line@ diabetes education robot program. Education was delivered individually in a one-on-one manner. Researchers spent 15 minutes instructing participants on the operation and usage of the Line@ diabetes education robot program, followed by educational content delivery. Educational sessions lasted for 30 minutes on the day of enrollment, and 15 minutes each at the 3rd and 6th months of enrollment, totaling three one-on-one educational sessions. Additionally, participants received telephone consultations for follow-up during the enrollment period. Telephone education sessions were conducted in the first week of enrollment, the second month, and the fourth month, each lasting 10 minutes, totaling three sessions.

The control group received routine education and had follow-up visits every three months for one-on-one education. Data collection for both groups occurred at the time of enrollment, and at the 3rd and 6th months of enrollment.

Conditions

Diabetic Patients,Self-Care,Artificial Intelligence-Based,Self-Efficacy; Type 2 Diabetes Mellitus (T2DM)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

LINE@ Diabetes Health Education Chatbot

The research involves the application of the "Diabetes Smart Helper" LINE@ Diabetes Health Education Chatbot for intervention measures. This application includes AI automatic message responses and provides push notifications of diabetes-related medical and healthcare knowledge to ensure that the public receives accurate medical information (Chinese Diabetes Health Education Association, 2021).

Group Type: OTHER

LINE@ Diabetes Health Education Chatbot

Intervention Type: BEHAVIORAL

Upon opening the LINE application, the research subjects need to enter "Diabetes Smart Helper" in the LINE@ Diabetes Health Education Chatbot. Once added to the program, the LINE interface will directly display six small windows for diabetes symptoms/complications, diet, medication, exercise, mental health, and others, facilitating self-selection by users.

Interventions

LINE@ Diabetes Health Education Chatbot

Upon opening the LINE application, the research subjects need to enter "Diabetes Smart Helper" in the LINE@ Diabetes Health Education Chatbot. Once added to the program, the LINE interface will directly display six small windows for diabetes symptoms/complications, diet, medication, exercise, mental health, and others, facilitating self-selection by users.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Diagnosed with type 2 diabetes by a physician and enrolled as a patient in the Diabetes Collaborative Care Network.

2. Aged 18 years or older.

3. Owns a smartphone and agrees to join the "Diabetes Smart Helper" LINE@ Diabetes Health Education Chatbot application.

4. HbA1c level greater than 7.0% (as referenced in Changsieng et al., 2023; Selçuk-Tosun & Zincir, 2019).

Exclusion Criteria

1. Patients undergoing hemodialysis or peritoneal dialysis.

2. Patients diagnosed with mental illness.

3. Illiterate patients.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chia-Tzu Line

OTHER

Sponsor Role: lead

Responsible Party

Chia-Tzu Line

head nurse

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

chia-tzu lin

Role: PRINCIPAL_INVESTIGATOR

not related

Locations

Wei Gong Memorial Hospital

Taiwan, Toufen City, China

Countries

China

Other Identifiers

WeiGongMemorial

Identifier Type: -

Identifier Source: org_study_id