NCT06160063

Brief Summary

In this study, in which education on acute complications of type 1 diabetes is planned with board games based on Bandura's social learning theory, children can indirectly learn common points that they may hear about acute complications of diabetes by watching board games of other group members. In line with this theory, children's knowledge needs regarding acute complications of diabetes can be determined, and interventions can be planned to meet the determined needs of children. Thus, the level of knowledge of diabetes health literacy for acute complications of diabetes can be increased. This study will be carried out in a randomized controlled manner to evaluate the effect of educational play in children on acute complications of diabetes and health literacy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

January 16, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 7, 2023

Completed
Last Updated

December 7, 2023

Status Verified

November 1, 2023

Enrollment Period

1 month

First QC Date

January 15, 2023

Last Update Submit

November 28, 2023

Conditions

Keywords

ChildhoodDiabetesHealth LiteracySocial Learning TheoryBoard Game

Outcome Measures

Primary Outcomes (2)

  • Validity and reliability of the "Health Literacy Scale for Acute Complications of Type 1 Diabetes for Children (8-12 Years)" in Turkish

    The Turkish validity and reliability of the "Health Literacy Scale for Acute Complications of Type 1 Diabetes for Children (8-12 Years)" was carried out. Scale items will be created by the researcher. The scale items will be presented to expert opinion and experts will be asked to evaluate the scale according to the Davis (1992) technique. Items that need to be revised will be reviewed and the final version of the scale will be created. Children who score higher on the scale will indicate a higher level of diabetes health literacy. The scale developed within the scope of the research will be filled in by children with diabetes themselves.

    6 month

  • Evaluation of Literacy Scale for Acute Complications of Diabetesfor Children with Type 1 Diabetes (8-12 years)

    The diabetes health literacy of children with type 1 diabetes aged 8-12 years who participated in our research was evaluated with the "Literacy Scale for Acute Complications of Diabetes for Children with Type 1 Diabetes (8-12 years)" scale. The scale was applied to the participants at the first meeting. Then, diabetes education was given to the participants through games. The scale was re-administered to the participants 1 and 3 months after the training. Participants were advised to play the game at least twice between follow-ups.

    Baseline, 4 weeks ve 12 weeks after randomization

Study Arms (2)

Experimental group

EXPERIMENTAL

It is planned to meet with the experimental group 3 times in total. In the first interview, first of all, "Diabetes Child Diagnosis Form" and "Diabetes Health Literacy Scale for Acute Complications in Children" will be applied. Then the diabetes health literacy board game will be played. For this, groups of 4 will be formed and care will be taken to ensure that children of similar age groups are together while forming groups. In the clinic, they will be asked to play a diabetes health literacy (DISOY) board game in a quiet, bright room, a room with a table and 4 chairs. DISOY board game averages 45-60 minutes. and the first meeting will end here. Each child will be given one game to play with their parents at least twice at home. The second interview will be provided 1 month after the first interview. The third interview will be held in the third month. Data collection forms will be filled out again at each interview.

Behavioral: Education intervention

control

NO INTERVENTION

control group; It is planned to meet with the control group 3 times in total. In the first, second and third interviews, only the data collection forms will be filled by the children. After collecting all the data of the experimental group, a board game will be given to the parents and children in the control group.

Interventions

Board game was created in line with current literature. In each interview, it is expected that the child's negative behaviors will be transformed into positive behaviors.

Experimental group

Eligibility Criteria

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

You may qualify if:

  • Diabetes age is at least one year
  • Regular attendance to the three-month routine outpatient clinics
  • Not having any other disease accompanying diabetes
  • The child is between 8-12 years old

You may not qualify if:

  • Children not coming to the given appointment
  • Children who do not play the diabetes health literacy (DISOY) board game at home

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul İl Sağlık Müdürlüğü

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: randomized control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
llecturer

Study Record Dates

First Submitted

January 15, 2023

First Posted

December 7, 2023

Study Start

January 16, 2023

Primary Completion

March 1, 2023

Study Completion

June 1, 2023

Last Updated

December 7, 2023

Record last verified: 2023-11

Locations