Clinical trial NCT06985680: Diabetic Patients,Self-Efficacy,Self-Care Behaviors,Artificial Intelligence-Based
Official title: Exploring the Impact of Artificial Intelligence-Based Health Education on Self-Efficacy, Self-Care Behaviors, and Glycemic Control in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Patients,Self-Care,Artificial Intelligence-Based,Self-Efficacy
Type 2 Diabetes Mellitus (T2DM)
Lead sponsor: WeiGong Memorial Hospital
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: The Chinese Version Diabetes Management Self-Efficacy Scale
timeFrame: 6 months.
measure: The Summary of Diabetes Self-Care Activities
timeFrame: 6 months.
measure: blood glucose control
timeFrame: 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Taiwan
country: China
facility: Wei Gong Memorial Hospital
state: Toufen City
Study officials:
affiliation: not related
name: chia-tzu lin
role: PRINCIPAL_INVESTIGATOR
References: