The Effect of Think-Find-Solve Activities on Insulin Self-Management in Children With Type 1 Diabetes: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in insulin self-management level among children with type 1 diabetes
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •The child uses an insulin pump
研究组 & 干预措施
Experimental Group
After the pre-test, children in the intervention group will receive the intervention using the "Insulin Self-Management Know-Find-Solve Activity Book," in addition to the standard education provided by diabetes nurses in accordance with the Ministry of Health Diabetes Educator Guide. The researcher will explain how to use the activity book, and the book will be given to the children to complete at home. Parents' contact information will be obtained, and children will be asked to complete the activities in the book at least twice a month for 3 months. Throughout the process, families will be contacted to monitor the implementation of the activities and to obtain feedback on the completed sections. Questions from children and parents regarding the activities will be answered by the researcher. Follow-up measurements will be conducted at the end of the 1st and 3rd months after the intervention.
干预措施: Insulin Self-Management Know-Find-Solve Activity Book (Other)
结局指标
主要结局
Change in insulin self-management level among children with type 1 diabetes
时间窗: 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.
次要结局
- 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)