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NCT07670572
Think-Find-Solve Activities for Insulin Self-Management in Type 1 Diabetes
Conditions: Type 1 Diabetes, Children, Activity, Insulin, Self Management, Parent
Sex: All
Ages: 8 Years – 12 Years
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: Marmara University
Location: S.B. Marmara University Pendik Training and Research Hospital Prof. Asaf Ataseven Additional Service Building Istanbul
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.
Eligibility Criteria
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
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Source: ClinicalTrials.gov (NCT07670572). StuddyBuddy aggregates publicly available trial information.