Think-Find-Solve Activities for Insulin Self-Management in Type 1 Diabetes

Официальное название

The Effect of Think-Find-Solve Activities on Insulin Self-Management in Children With Type 1 Diabetes: A Randomized Controlled Trial

Обзор

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.

Вмешательства

• Другое Insulin 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
• Другое Routine 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.

Первичные конечные точки

• Change in insulin self-management level among children with type 1 diabetes [Срок оценки: Baseline, 1 month after the intervention, and 3 months after the intervention]

Вторичные конечные точки (1)

• Change in parent-reported insulin treatment self-management level of children with type 1 diabetes [Срок оценки: Baseline, 1 month after the intervention, and 3 months after the intervention]

Критерии участия

Критерии включения

• 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

Критерии исключения

The child uses an insulin pump

\-

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• Marmara University — Istanbul

Публикации

• 1. Ogle, G. D., Wang, F., Haynes, A., Gregory, G. A., King, T. W., Deng, K., ... & Maniam, J. (2025). Global type 1 diabetes prevalence, incidence, and mortality estimates 2025: Results from the International diabetes Federation Atlas, and the T1D Index Version 3.0. Diabetes Research and Clinical Practice, 112277. 2. T.C. Sağlık Bakanlığı Halk Sağlığı Genel Müdürlüğü,. 2020. Çocukluk Çağı Diyabeti

Идентификаторы

NCT: NCT07670572 · 30.04.2026/123

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗