Game-Based Education and Treatment Adherence in Type 2 Diabetes

NCT07195188 | Completed DMC

• 1 other identifier: 352-352-10
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if an education program can help lower anxiety and improve treatment follow-up in adults with type 2 diabetes. The main questions it aims to answer are: Does attending the education program lower anxiety levels? Does it help people better follow their diabetes treatment plan? Researchers will compare two groups: Education group: Participants who attend the program. Control group: Participants who do not attend the program. Participants will: Be randomly assigned to either the education group or the control group. Attend four weekly sessions, each lasting two hours, over one month (education group only). Complete surveys before and after the program, including the Beck Anxiety Scale (to measure anxiety) and the Patient Compliance Scale for Type 2 Diabetes Mellitus Treatment (to measure treatment follow-up).

Conditions

Type 2 Diabetes; Diabete Mellitus

Keywords

Type 2 Diabetes, Insulin Therapy, Game-Based Education, Treatment Adherence, Anxiety, Randomized Controlled Study, Nursing Education, Patient Education

Outcome Measures

Primary Outcomes (1)

• Treatment Compliance Levels

  For Treatment Compliance: The level of compliance among individuals undergoing diabetes-to-diabetes treatment was determined using the Patient Compliance Scale for Type 2 Diabetes Treatment, a 30-item, five-point Likert-type scale. A low total score indicates high patient compliance. For Anxiety: "Anxiety levels of individuals with diabetes were determined using the Beck Anxiety Scale (BAS), a 21-item, four-point Likert-type self-report scale. Higher scores indicate more severe anxiety.

  Pre-intervention and Post-intervention (After 1 Month of Training)

Study Arms (2)

Game-Based Education

EXPERIMENTAL

Arm Description: Participants in this group will receive diabetes education using the "Let's Learn Diabetes" board game. The program consists of four weekly sessions, each lasting two hours, conducted over one month. The sessions aim to improve diabetes knowledge, reduce anxiety, and increase adherence to insulin therapy.

Behavioral: "Let's Learn Diabetes" Game-Based Education

Traditional Diabetes Education

ACTIVE COMPARATOR

Participants in the control group will receive standard diabetes education through traditional lecture-based presentations. The education schedule matches the experimental group with four weekly sessions, each lasting two hours, over one month.

Behavioral: Traditional Diabetes Education

Interventions

"Let's Learn Diabetes" Game-Based Education BEHAVIORAL

Participants in the experimental group will receive diabetes education using the "Let's Learn Diabetes" board game. The program consists of four weekly sessions, each lasting two hours, over one month. The intervention is designed to improve diabetes knowledge, reduce anxiety, and enhance treatment adherence among patients with Type 2 Diabetes Mellitus on insulin therapy.

Game-Based Education

Traditional Diabetes Education BEHAVIORAL

Participants in the control group will receive standard diabetes education through traditional lecture-based presentations. The education schedule matches the experimental group with four weekly sessions, each lasting two hours, over one month.

Traditional Diabetes Education

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Age at diagnosis of diabetes is recent or less than 1 year.
• Being on insulin therapy for more than three months.
• Mental or psychological comorbidity.
• Not within the target age range, under 40 years or over 65 years.
• Refusing to participate in the research.
• Not attending one or more of the four training sessions during the research process.

Sponsors & Collaborators

• Izmir Tinaztepe University: lead
• Usak State Hospital: collaborator

Study Sites (1)

Uşak Eğitim Ve Araştırma Hastanesi

Uşak, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Treatment Adherence and Compliance; Anxiety Disorders

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Health Behavior; Behavior; Mental Disorders

Study Officials

• Gönül düzgün, phd

  Izmir Tinaztepe University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant profesor

Model Details: two groups

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 26, 2025
• Study Start: April 5, 2024
• Primary Completion: May 3, 2024
• Study Completion: November 30, 2024
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

TU (1)