Clinical trial NCT06535672: The Effect of Kamishibai Diabetes Education on Knowledge, HbA1c, and Quality of Life in Children
Official title: The Effect of Diabetes Education Given to Children Diagnosed With Type 1 Diabetes Mellitus Using the Kamishibai Method on Patients' Knowledge Level, HbA1c Parameter, and Quality of Life: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: DIABETES EDUCATION
Keywords: Type 1 Diabetes Mellitus (Type 1 DM)
Kamishibai method
Hemoglobin A1c (HbA1c)
Pediatric diabetes education
Quality of life in children
Randomized controlled tria
Lead sponsor: Okan University
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Stratified randomized controlled trial
Primary purpose: PREVENTION

Brief summary: Children diagnosed with Type 1 Diabetes Mellitus (T1DM) initially receive intensive education with their families. Studies indicate that over time, this initial education becomes routine, reducing its effectiveness and failing to adequately address developmental stages, thus requiring repetition. Current methods involve long and intensive educational sessions in hospitals using the Childhood Diabetes Education Guide. These extended, non-interactive sessions often lead to a loss of motivation, decreased learning efficiency, and negative attitudes among patients and their families.

This study aims to develop an educational tool utilizing the Kamishibai method specifically for children with T1DM aged 8-12. The Kamishibai method is designed to align with their cognitive and sensory development, promoting effective and engaging learning experiences for diabetic patients. By incorporating interactive and visually stimulating elements, Kamishibai seeks to enhance motivation and retention of diabetes education.

Hypothesis 1: Children diagnosed with Type 1 DM have higher knowledge levels in the group educated with the Kamishibai method compared to those receiving routine education.

Hypothesis 2: The Hemoglobin A1c parameter is lower in the Kamishibai-educated group.

Hypothesis 3: The quality of life is higher in the Kamishibai-educated group.

This study will assess the effectiveness of the Kamishibai method by comparing it to routine educational approaches. The detailed protocol includes technical aspects of the intervention, measurement tools, data collection methods, and statistical analysis plans to ensure a comprehensive evaluation of the method's impact on knowledge levels, HbA1c parameters, and quality of life.

Detailed description: This study is a randomized controlled trial designed to examine the impact of diabetes education using the Kamishibai method on knowledge levels, HbA1c parameters, and quality of life in children diagnosed with T1DM. The study protocol is detailed below.

Data Collection Tools: The Child Information Form, Diabetes Knowledge Level Evaluation Form, PedsQL 3.0 Quality of Life Scale for Children with Type 1 Diabetes (Child Form), Blood Sugar and HbA1c Monitoring Diary, and Kamishibai Education Feedback Form will be used.

Implementation:

The study data will be collected using a stratified random sampling method. Children aged 8-12 years who meet the inclusion criteria will be stratified by their HbA1c values and divided into two groups by block randomization (n=30 intervention, n=30 control). The intervention group will receive Kamishibai diabetes education, while the control group will receive routine diabetes education. Information about the study will be provided to eligible children and parents. Informed consent will be obtained from those agreeing to participate. Data collection forms will be filled out. Each child will have follow-up diabetes nurse appointments 1 week after the education and doctor appointments 10 days later.

Intervention Group (n=30):

Patients in the intervention group will receive Kamishibai diabetes education, completed over 3 days with 3 sessions per day. Post-education data collection forms will be administered, taking approximately 30 minutes to complete. Patients will be informed about follow-up checks and the process for the next 3 months.

Control Group (n=30):

Patients in the control group will receive routine diabetes education over 3 days with 3 sessions per day. The education will use a PowerPoint presentation and a whiteboard according to the Ministry of Health's Childhood Diabetes Education guide. Simple, understandable language will be used for children's comprehension. The education will be interactive, encouraging feedback and questions.

Form and Metabolic Tests Application at the 3rd and 6th Month:

At the 3rd and 6th months post-education, patients attending doctor check-ups will visit the diabetes education unit. HbA1c and data collection forms will be administered 3 and 6 months post-education. Filling out the forms will take approximately 15-20 minutes.

Population and Sample of the Study:

The study population consists of children aged 8-12 years (N=101) followed at Istanbul Zeynep Kâmil Women and Children's Diseases Training and Research Hospital between January 1, 2024, and April 29, 2024. The sample includes patients diagnosed with Type 1 Diabetes who meet the inclusion criteria from the population.

Inclusion Criteria for the Sample:

Children aged 8-12 years Being followed up for at least 1 year with a diagnosis of Type 1 diabetes Being followed as outpatients Using insulin Able to understand and speak Turkish

Exclusion Criteria for the Sample:

Presence of another chronic disease that could affect glycemic control apart from Type 1 diabetes Using an insulin pump Having vision and/or hearing problems Having mental and/or neurological issues Having a diagnosis of a psychiatric disorder

Exclusion Criteria from the Sample:

The child and/or family not wishing to continue the study The child not participating in the entire education program Diagnosis of a different disease affecting glycemic control during the study The child's treatment continuing in another institution Not attending the regular 3-month check-ups Dependent Variables: Patients' diabetes knowledge score, HbA1c values, and Quality of Life Scale score in children with Type 1 Diabetes.

Independent Variables: Diabetes education using the Kamishibai method, routine diabetes education.

Sample Size: Determined using G. POWER 3.1.9.7 (Heinrich-Heine-Universität Düsseldorf, Germany). Values from a study by Alzawahreh and Öztürk (2024) on adolescents diagnosed with T1DM were used for HbA1c scores. With a 5% alpha error (α=0.05), 10% beta error (β=0.10), and 0.80 power (d=0.804), a total of 60 participants (30 in the intervention group, 30 in the control group) were determined. Considering potential losses, the sample size was increased by 10%. The study is planned with 66 children (33 in the intervention group, 33 in the control group).

Data Collection: Written permission was obtained from the Ethics Committee of Zeynep Kamil Women and Children's Diseases Training and Research Hospital and research permission from the Istanbul Governorship Provincial Health Directorate. After explanations to families of eligible children, verbal and written informed consent will be obtained from participants' families. Personal information will be kept confidential, and their privacy will be respected during the study. Data will be collected between July 2024 and July 2025.

Data Analysis: The data will be analyzed using SPSS 26.0 (Statistical Package for Social Science). Arithmetic mean (Mean), standard deviation (SD), minimum and maximum values will be used for continuous variables. Frequency and percentage calculations will be used for categorical variables. Cronbach's alpha coefficient will determine the internal consistency of the scale items. The Kolmogorov-Smirnov test will assess normal data distribution. Non-parametric tests will be used if data do not show normal distribution. "Chi-square" and "Fisher exact" tests will compare groups with categorical data. The "Mann Whitney U" test will compare numerical data between groups and examine differences between scale averages. The "Friedman test" will examine numerical variable differences at different times within a group. "Spearman correlation" analysis will examine the relationship between scales. In all tests, p \< 0.05 will be considered statistically significant.

Eligibility criteria: Inclusion Criteria:

* The child is 8-12 years old.
* Diagnosed with Type 1 Diabetes Mellitus (T1DM) for at least 1 year.
* Followed up on an outpatient basis.
* The child is using insulin.
* The child can understand and speak Turkish.

Exclusion Criteria:

* Presence of another chronic disease other than T1DM that may affect glycemic control.
* Using an insulin pump.
* Having vision and/or hearing problems.
* Having a mental and/or neurological problem.
* Having a diagnosis of a psychiatric disease.

Primary outcomes:
measure: Quality of Life Assessed by the PedsQL 3.0 Child Form
timeFrame: At baseline, three months later, six months later (15 minutes ago)
measure: HbA1c Value Assessed by Blood Test Results
timeFrame: At baseline, three months later, six months later (15 minutes ago)
measure: Diabetes Knowledge Level Assessed by the Diabetes Knowledge Level Evaluation Form
timeFrame: At baseline (5 minutes ago)
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Work
state: Üsküdar
Study officials:
affiliation: Sakarya University of Applied Sciences Faculty of Health Sciences
name: Gülzade Uysal, Assoc.Dr.
role: PRINCIPAL_INVESTIGATOR
References: