The Effect Of Model-Based Dıgıtal Game On Metabolıc Control, Self-Effıcıency And Qualıty Of Lıfe In Chıldren Wıth Type 1 Dıabetes

Abant Izzet Baysal University

Status: Enrolling

Conditions: Type 1 Diabetes; Children, Only

Treatments: Behavioral: Dijital Game and Health Education

Study type: Interventional

Funder types: Other

Identifiers

NCT05923632

AİBÜ-HEM-BA-01

Details and patient eligibility

About

This study was planned to determine the effect of model-based digital game on metabolic control, self-efficacy and quality of life in children with T1DM.

Full description

This study was planned to determine the effect of model-based digital game on metabolic control, self-efficacy and quality of life in children with T1DM. This study was planned as a randomized controlled trial with a pre-post test parallel group. Participants to be included in the study, In this study, children between the ages of 8-13 who were diagnosed with T1DM and followed up in the Pediatric Endocrinology outpatient clinics and services of two hospitals in two different centers will be selected. During the follow-up days of the children in the outpatient clinic, the diabetes nurse will be contacted to discuss working with the child with T1DM and their families. After the child and their parents are informed about the purpose and application of the study, that the collected data will only be used for scientific research purposes, the children and their families who gave their consent to participate in the study will be asked to sign the volunteering form. Children who agree to participate in the study will be given a password to log in to the created web page. Experimental and control groups will be determined according to the order of login with this password and randomization with https://www.randomizer.org/. Standard diabetes education was given to both groups before the game intervention to be applied to the experimental group; Children entering the site will be asked to fill in the Child with Type 1 Diabetes Descriptive Information Form, the Quality of Life in Children with Type 1 Diabetes Scale and the Diabetes Management Self-Efficacy Scale in Children with Type 1 Diabetes. After informing the children in the experimental group about the game designed based on The Information-Motivation-Behavioral Skills Model(IMB) of diabetes management on the website, it will be ensured that the children actively participate in the game for 9 weeks and their participation status in the background of the game will be followed; At the end of 9 weeks, all stages of the game will be required to be completed. Reminders will be made by contacting the children who have not completed the game in line with the follow-ups in the background, once a week. During this process, the control group; On a weekly basis, slides supported with visuals related to nutrition, exercise and drug use will be presented on the web page in the form of sessions. Children will be provided to watch each session. Whether the children complete the sessions or not will be monitored from the background. Children who do not complete the sessions will be reminded once a week.

All scales will be re-administered to both groups at the 12th week (3 weeks after the training). Scales will also be applied through the website. HbA1c and other blood levels of the parameters to be used in the study will be obtained from the hospital files at the beginning of the study and at the end of the 12th week, as they are routinely requested during the controls. At the end of the study, the control group will also be allowed to log in to the game via the website in terms of ethical compliance.

Enrollment: 58 estimated patients

Sex: All

Ages: 8 to 13 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Being in the 8-13 age range,
• Being diagnosed with T1DM at least 6 months ago,
• Ability to read and write Turkish,
• Ability to communicate verbally,
• To have Internet access,
• Computer, tablet, etc. to have and use technological tools,
• To volunteer to participate in the study

Exclusion criteria

• Having another chronic disease other than T1DM

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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58 participants in 2 patient groups

Pediatric patients with type 1 diabetes

Experimental group

Description:

By providing standard diabetes education before the digital game intervention, the child who enters the game will be asked to fill out the Child with Type 1 Diabetes Descriptive Information Form, the Quality of Life in Children with Type 1 Diabetes Scale, and the Diabetes Management Self-Efficacy Scale in Children with Type 1 Diabetes.After the children in the experimental group are informed about the digital game designed according to the Information-Motivation-Behavioral Skills Model (IIMB) in diabetes management, active participation of the children in the digital game will be ensured for 9 weeks, and participation status will be followed in the background of the game.At the end of 9 weeks, children will be asked to complete all stages of the game.Children who do not complete the game will be contacted once a week in line with the follow-up, and reminders will be made.At the 12th and 15th weeks (3 and 6 weeks after the training), all the scales will be administered again.

Treatment:

Behavioral: Dijital Game and Health Education

Pediatric patients with type 1 diabetes receiving routine care

No Intervention group

Description:

At the beginning of the study, standard diabetes education will be given, and they will be asked to fill out the Children with Type 1 Diabetes Information Form, the Quality of Life Scale for Children with Type 1 Diabetes, and the Diabetes Management Self-Efficacy Scale. All scales will be administered again in the 12th and 15th weeks from the beginning of the study.