Activity, Children, Insulin, Parent, Self Management, Type 1 Diabetes
Conditions
Keywords
type 1 diabetes, children, activity, insulin, self management, parent
Brief summary
Children with type 1 diabetes require lifelong insulin therapy. However, improper management of insulin therapy may lead to serious, potentially life-threatening complications. The aim of this study is to examine the effect of an activity book developed for insulin therapy on insulin self-management among children with type 1 diabetes and their parents. The study is designed as a cluster randomized controlled experimental trial at the center level, including pre-test, 1- month, and 3-month follow-up measurements. The study will be initiated after obtaining ethical approval and institutional permissions. The sample will consist of children aged 8-12 years with type 1 diabetes and their parents. The study will be conducted in two different hospitals in Istanbul; using cluster randomization, one hospital will be assigned to the intervention group and the other to the control group. Prior to the main study, a pilot study will be conducted with 15 participants in each group, and the sample size will be calculated using G\*Power based on the pilot data. Data will be collected using the "Descriptive Information Form for Children with Diabetes" and the "Insulin Treatment Self-Management Scale (ITSMS) - Child (8-18 years) and Parent Forms." The "Find-Solve-Learn Insulin Self-Management Activity Book" will be applied to the children in the intervention group. The children will be monitored to complete the activity book at least twice a month for three months, and feedback will be obtained from their families regarding the process. The data collection process will include pre-test, 1-month, and 3-month follow-up measurements. The obtained data will be analyzed using appropriate statistical methods.
Interventions
OTHERInsulin Self-Management Know-Find-Solve Activity Book
The Insulin Self-Management Find-Search-Solve Activity Book was developed based on national and international literature to improve insulin-related self-management skills in children aged 8-12 years with type 1 diabetes. It aims to help children distinguish correct and incorrect insulin practices, take responsibility, make appropriate decisions, and apply their knowledge in daily life. The erasable and reusable book was designed to be safe and child-friendly. It contains 19 activities across 22 pages, including puzzles, word searches, matching, coloring, fill-in-the-blanks, true-false questions, riddles, and identification of insulin injection sites. Six experts evaluated the book, and the overall Content Validity Index calculated using the Davis technique was 0.98. Following pilot testing, the book will be finalized according to participant feedback.
OTHERRoutine education
Parents' contact information will be obtained, and the follow-up process will be maintained. The same data collection tools will be administered at time points parallel to those of the intervention group. After completion of the study, in line with the principle of ethical equity, children in the control group will also be given the "Insulin Self-Management Know-Find-Solve Activity Book" as a gift.
Sponsors
Marmara University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to the nature of the intervention, masking of participants - children and parents - and the researcher delivering the intervention is not feasible. However, to reduce measurement and analysis bias, masking will be maintained during the data analysis process by coding the groups as Group A and Group B. In addition, all statistical analyses will be performed by an independent statistician who will be masked to group allocation.
Intervention model description
This study will be conducted using an experimental, cluster-randomized controlled design at the center level, with measurements at pre-test, post-test (1 month), and 3-month follow-up.
Eligibility
Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* For the child: Diagnosed with Type 1 diabetes Aged between 8 and 12 years Able to read and write Able to understand and speak Turkish Diagnosed with diabetes for at least one year Regularly attending routine three-month outpatient clinic follow-ups Having no other diseases or medical conditions aside from diabetes The child agrees to participate in the study -For the Parent: Being the mother or father of the child with Type 1 diabetes Being the primary caregiver responsible for the child Able to read and write Agrees to participate in the study
Exclusion criteria
The child uses an insulin pump \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in insulin self-management level among children with type 1 diabetes | Baseline, 1 month after the intervention, and 3 months after the intervention | The primary outcome is the change in insulin treatment-related self-management level of children with type 1 diabetes. Higher scores will indicate better insulin self-management. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in parent-reported insulin treatment self-management level of children with type 1 diabetes | Baseline, 1 month after the intervention, and 3 months after the intervention | The secondary outcome is the change in parent-reported insulin treatment self-management level of children with type 1 diabetes. |
Countries
Turkey (Türkiye)
Contacts
CONTACTFatma Toksöz Güneş, MsC, PhD Candidate
Outcome results
None listed