Clinical trial NCT05923632: The Effect Of Model-Based Dıgıtal Game On Metabolıc Control, Self-Effıcıency And Qualıty Of Lıfe In Chıldren Wıth Type 1 Dıabetes
Official title: The Effect Of Model-Based Dıgıtal Game On Metabolıc Control, Self-Effıcıency And Qualıty Of Lıfe In Chıldren Wıth Type 1 Dıabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Pediatric Nursing
Keywords: Self Management
Diabetes
Digital Game
Life Quality
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment Randomized Controlled Trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of Life Scale for Children with Type 1 Diabetes (PedsQL 3.0)
timeFrame: 30 minutes
Secondary outcomes:
measure: Diabetes Management Self-Efficacy Scale in Adolescents with Type 1 Diabetes
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Bolu Abant İzzet Baysal Üniversitesi
city: Zonguldak
country: Turkey
facility: Zonguldak Bülent Ecevit Üniversitesi
Study officials:
affiliation: Zonguldak Bulent Ecevit University
name: Özgür Bahadır, Msc
role: PRINCIPAL_INVESTIGATOR
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