NCT05649553

Brief Summary

This research will be conducted to evaluate the effect of digital game and video animation-based diabetes education on the quality of life of children with Type 1 Diabetes. HbA1c, diabetes knowledge and Quality of Life Scale in Children with Diabetes (PedsQL 3.0) score will be taken into consideration when evaluating the quality of life of children with type 1 diabetes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 14, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

November 13, 2024

Status Verified

November 1, 2024

Enrollment Period

8 months

First QC Date

December 6, 2022

Last Update Submit

November 11, 2024

Conditions

Keywords

diabetes educationdigital gamevideo animation

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c

    Measuring the changes in HbA1c levels of children with type 1 diabetes before training and at the 3rd and 6th months after training.

    Baseline, 3. and 6. months

Secondary Outcomes (1)

  • Changes in quality of life

    Baseline, 3. and 6. months

Study Arms (2)

Intervention Group

EXPERIMENTAL

Experimental: Intervention Group Application of the Introductory Information Form and the "Quality of Life Scale in Children with Diabetes Mellitus (PedsQL 3.0 Diabetes Scale)" test Giving digital game and video animation-based diabetes education to the children in the experimental group, in addition to the education given by the diabetes nurse, Applying the first post-training follow-up test to children in the experimental and control groups 3 months after the training. Applying the post-training-2nd follow-up test to the children in the experimental and control groups 6 months after the training.

Behavioral: digital game and video animation based diabetes education

Control Group

NO INTERVENTION

The control group received routine nursing care in the endocrine policlinic.

Interventions

While creating the digital game and video animation, an agreement was made with a software company and this company was responsible for the software and repair of the game. Digital games and video animations cover the basic educational topics of Type 1 diabetes. Expert opinions were received from experts in the field of Child Health and Disease Nursing to ensure the suitability of the content of the educational material. The name of the game site and how to use it were explained to the children in the intervention group by the researcher. In addition, children in the intervention group were given usernames and passwords to log in to the site. Game Sections; What is Diabetes? Medical Nutrition Treatment in Diabetes, Insulin Treatment and Application, Exercise and Physical Activity in Diabetes, Complications of Type 1 Diabetes Mellitus, Diabetes Management at School.

Also known as: digital game, video animation
Intervention Group

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children's willingness to participate in the research (written consent of their parents, verbal consent was obtained from the children),
  • Being between the ages of 8-12,
  • Having been diagnosed with Type 1 Diabetes Mellitus at least 1 year ago
  • To have regular follow-ups,
  • No communication disability (speech, hearing, vision problems)
  • It means having a device (computer) with internet connection at home and being able to use it.

You may not qualify if:

  • Having any chronic disease together with diabetes,
  • Using an insulin pump

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Sebahat ALTUNDAĞ, AssocProfDr.

    Pamukkale University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single blinding was provided that included inclusion criteria and agreement to participate in the study.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study is a parallel group randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Principal Investigator

Study Record Dates

First Submitted

December 6, 2022

First Posted

December 14, 2022

Study Start

September 15, 2022

Primary Completion

May 15, 2023

Study Completion

September 15, 2023

Last Updated

November 13, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations