Think-Find-Solve Activities for Insulin Self-Management in Type 1 Diabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-12
SponsorMarmara University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Insulin Self-Management Know-Find-Solve Activity Book
Other interventionThe Insulin Self-Management Find-Search-Solve Activity Book was developed by the researchers in line with national and international literature to improve insulin treatment-related self-management skills in children aged 8-12 years with type 1 diabetes. The book aims to support children in distinguishing correct and incorrect practices related to insulin therapy, developing a sense of responsibility, improving decision-making skills, and transferring what they have learned into daily life. It consists of erasable and reusable pages and was designed to be safe and suitable for children's use. The book includes 19 activities and 22 pages, such as puzzles, word searches, matching, coloring, fill-in-the-blanks, true-false questions, riddles, and identifying insulin injection sites. Expert opinions were obtained from six specialists, and the total Content Validity Index calculated using the Davis technique was 0.98. After the pilot implementation, the book will be finalized based on feedbac
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Experimental GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in insulin self-management level among children with type 1 diabetes
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.
Time frame
Baseline, 1 month after the intervention, and 3 months after the interventionSecondary outcomes
1
Change in parent-reported insulin treatment self-management level of children with type 1 diabetes
The secondary outcome is the change in parent-reported insulin treatment self-management level of children with type 1 diabetes.
Time frame
Baseline, 1 month after the intervention, and 3 months after the interventionOther outcomes
1
Validity of the Insulin Self-Management Find-Search-Solve Activity Book
The validity of the Insulin Self-Management Know-Find-Solve Activity Book will be evaluated as a pre-specified methodological outcome. Content validity will be assessed based on expert opinions using the Davis technique and the Content Validity Index. Face validity will be evaluated through pilot implementation with children with type 1 diabetes who meet the inclusion criteria. Feedback from children will be used to assess the clarity, comprehensibility, and suitability of the activity book.
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov
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