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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).
Full 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
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
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.
Enrollment
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Inclusion and exclusion criteria
nclusion Criteria:
Age at diagnosis of diabetes is at least 1 year.
The maximum duration of insulin treatment initiation is 3 months.
Not having any mental problems.
Between the ages of 40 and 65 years.
Volunteering to participate in the study.
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.
Primary purpose
Allocation
Interventional model
Masking
72 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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