Game-Based Education and Treatment Adherence in Type 2 Diabetes

NCT ID: NCT07195188

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-05
• Study Completion Date: 2024-11-30

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).

Detailed Description

Study Type: This is a clinical trial that tests a diabetes education program. Number of Participants: A total of 72 people participated in the study

Group Assignment: Participants were randomly assigned to one of two groups:

Game-Based Education Group Traditional Education Group Study Model: Both groups were given diabetes education simultaneously, but through different methods Blinding: This was an open-label study in which both the researchers and the participants were aware of the type of education they received

Main Goal: To test whether a game-based education program can:

Improve how well people follow their diabetes treatment plan Lower anxiety levels in people recently starting insulin therapy Groups and Interventions

1. Game-Based Education Group (Experimental Group) Intervention: "Let's Learn Diabetes" Board Game

Description:

Participants received diabetes education through an interactive, game-based program.

The program consisted of four weekly sessions, each lasting two hours, over the course of one month

The sessions involved group play to help participants:

Improve their knowledge about diabetes Reduce anxiety related to diabetes care Follow their treatment plan more closely

2. Traditional Education Group (Control Group) Intervention: Standard Diabetes Education via Lecture

Description:

Participants received standard education using lecture-style presentations. The schedule was the same as the game-based group: four weekly sessions, each two hours long.

Study Outcomes

Researchers measured two main outcomes before the study and one month after the last session:

Treatment Adherence How well participants followed their treatment plan. Measured using the Patient Compliance Scale for Type 2 Diabetes Mellitus Treatment (a survey that asks questions about treatment follow-up).

Anxiety Levels How anxious participants felt about their condition and treatment. Measured using the Beck Anxiety Scale (a survey that measures anxiety).

Who Could Join the Study

Participants were eligible if they:

Had a diagnosis of type 2 diabetes. Started insulin treatment within the past three months. Were 18 years or older. Could read and understand Turkish, since the program was in Turkish. Were willing to sign a consent form and take part in all study activities.

Participants were NOT eligible if they:

Had cognitive problems, severe psychiatric disorders, or dementia that would make participation difficult.

Had severe diabetes-related complications, such as diabetic ketoacidosis or advanced kidney failure.

Had completed a structured diabetes education program in the last six months. Had any other condition that researchers believed would make participation unsafe or inappropriate.

Timeline Study Start Date: April 2024 Final Data Collection Date: October 2024

Program Duration per Participant:

4 weeks total - one two-hour session each week. A follow-up check was done one month after the final session.

Location

The study was carried out at:

Uşak Training and Research Hospital, Diabetes Education Unit and Diabetes School, Uşak, Turkey.

Conditions

Type 2 Diabetes; Diabete Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Game-Based Education

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.

Group Type: EXPERIMENTAL

"Let's Learn Diabetes" Game-Based Education

Intervention Type: 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.

Traditional Diabetes Education

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.

Group Type: ACTIVE_COMPARATOR

Traditional Diabetes Education

Intervention Type: 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.

Interventions

"Let's Learn Diabetes" Game-Based Education

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.

Intervention Type: BEHAVIORAL

Traditional Diabetes Education

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Usak State Hospital

OTHER

Sponsor Role: collaborator

Izmir Tinaztepe University

OTHER

Sponsor Role: lead

Responsible Party

gönül düzgün

assistant profesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gönül düzgün, phd

Role: STUDY_DIRECTOR

Izmir Tinaztepe University

Locations

Uşak Eğitim Ve Araştırma Hastanesi

Uşak, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

352-352-10

Identifier Type: -

Identifier Source: org_study_id