ChildhoodNCT06160063
Diabetes Acute Complications and Health Literacy in Children
A study testing Education intervention in people with Childhood and Diabetes, run by University of Yalova at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Childhood, Diabetes, Health Literacy
- What is being tested?
- Education intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Jan 2023to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Children not coming to the given appointment
- Children who do not play the diabetes health literacy (DISOY) board game at home
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Educational Play on Diabetes Acute Complications and Health Literacy in Children: A Randomized Controlled Study
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.
Read the detailed description
This study was conducted to determine the Turkish validity and reliability of the "Health Literacy Scale for Acute Complications of Type 1 Diabetes for Children (8-12 Years)" and to provide a diabetes health literacy box game to 8-12 school age children diagnosed with Type 1 diabetes. It will be carried out in two stages in order to evaluate the effect of educational games on acute complications of diabetes and health literacy in children.
In the first stage of the research, a general screening methodological method will be carried out to determine the current situation by quantitative analysis of the data obtained with the "Health Literacy Scale for Acute Complications of Type 1 Diabetes for Children (8-12 years)".
In the second stage; Randomly determined intervention and control groups will be applied to the intervention and control groups in a quasi-experimental type at the pre-test and the 1st and 3rd months after the training.
- Conditions
- Childhood, Diabetes, Health Literacy
- Being tested
- Education intervention
- Keywords
- Childhood, Diabetes, Health Literacy, Social Learning Theory, Board Game
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 4 weeks ve 12 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start16 Jan 2023
- Primary completion1 Mar 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomized control
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Yalova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Yeşil, University of Yalova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160063
- Sponsor's protocol ID
- 2023
- Status last verified
- Nov 2023
- First submitted
- 15 Jan 2023
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Educational Play on Diabetes Acute Complications and Health Literacy in Children: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06160063
- Acronym / sponsor ID
- 2023
- Conditions
- Childhood, Diabetes, Health Literacy
- Keywords
- Childhood, Diabetes, Health Literacy, Social Learning Theory, Board Game
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of YalovaUniversity, hospital or other
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 7 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study was conducted to determine the Turkish validity and reliability of the "Health Literacy Scale for Acute Complications of Type 1 Diabetes for Children (8-12 Years)" and to provide a diabetes health literacy box game to 8-12 school age children diagnosed with Type 1 diabetes. It will be carried out in two stages in order to evaluate the effect of educational games on acute complications of diabetes and health literacy in children.
In the first stage of the research, a general screening methodological method will be carried out to determine the current situation by quantitative analysis of the data obtained with the "Health Literacy Scale for Acute Complications of Type 1 Diabetes for Children (8-12 years)".
In the second stage; Randomly determined intervention and control groups will be applied to the intervention and control groups in a quasi-experimental type at the pre-test and the 1st and 3rd months after the training.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized control
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Education interventionIt 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. |
| 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. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Children not coming to the given appointment
- Children who do not play the diabetes health literacy (DISOY) board game at home
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education interventionBoard 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. | Behavioural | Experimental group |
Primary outcome
Validity and reliability of the "Health Literacy Scale for Acute Complications of Type 1 Diabetes for Children (8-12 Years)" in Turkish
Time frame: 6 month
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.
Evaluation of Literacy Scale for Acute Complications of Diabetesfor Children with Type 1 Diabetes (8-12 years)
Time frame: Baseline, 4 weeks ve 12 weeks after randomization
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education intervention in people with Childhood and Diabetes, run by University of Yalova at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity and reliability of the "Health Literacy Scale for Acute Complications of Type 1 Diabetes for Children (8-12 Years)" in Turkish (time frame: 6 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.