"Perception, Knowledge, and Attitudes of Educational Staff Regarding the Care of Children With Type 1 Diabetes: Evaluation of the Educational Program" (PKA-T1D-EDU)

August 29, 2025 updated by: Nevena Simunic, Sibenik University of Applied Sciences

Type 1 diabetes is a chronic autoimmune disease that requires continuous monitoring and regulation of glycemia. Children with type 1 diabetes face challenges that can disrupt their daily routines in school and kindergarten. This includes the need for self-monitoring, continuous blood sugar measurement, insulin administration, proper nutrition, regular physical activity, and timely interventions in cases of hypoglycemia or hyperglycemia. Therefore, children with diabetes often require support from educational staff, including teachers, preschool educators, and other professional personnel while attending educational institutions.

A safe and supportive (pre)school environment is crucial for maintaining the health and well-being of children with type 1 diabetes. Teachers and preschool educators, as key actors in the daily (pre)school life of the child, play an important role in recognizing disease symptoms and managing emergencies. However, research shows that many teachers lack sufficient knowledge about the symptoms of diabetes and the necessary procedures in emergencies, which can endanger the health and safety of the child, as well as their equal participation in educational activities.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
    • Hrvatska
      • Šibenik, Hrvatska, Croatia, 22000
        • Osnovna škola Tin Ujević, Dječji vrtići Smilje
    • Šibenik
      • Šibenik, Šibenik, Croatia, 22000
        • Osnovna škola Tin Ujević, Dječji vrtići Smilje, Šibenik, Hrvatska 22000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Educational staff employed in primary schools and/or kindergartens within the study area
  • Individuals willing to participate who have provided informed consent
  • Participants available for all planned assessments during the study period.

Exclusion Criteria:

  • Educational staff who have type 1 diabetes themselves, to avoid bias in the assessment of knowledge, perceptions, and attitudes due to personal experience with the disease
  • Educational staff who have close family members (parent, child, spouse, sibling) diagnosed with type 1 diabetes, as personal experiences and additional knowledge gained through family circumstances could affect the objectivity of the results
  • Individuals unable to participate in all phases of the study (e.g., due to planned absence or other reasons)
  • Individuals who are unwilling or unable to provide informed consent
  • This description clearly defines who is eligible and who is excluded from participation, ensuring the representativeness and objectivity of the study sample.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group - Education Program
Participants in the intervention group completed a baseline questionnaire assessing perceptions, knowledge, and attitudes about type 1 diabetes care. They then participated in an educational program specifically designed to improve these aspects. Immediately following the education, participants completed a second questionnaire. A third questionnaire was administered 3 months after the intervention to assess retention of knowledge and changes in attitudes and perceptions.
Behavioral: Education Program
This intervention consists of a structured educational program specifically designed for educational staff in primary schools and kindergartens, focusing on the care of children with type 1 diabetes. The program includes interactive lectures, practical workshops, and case studies covering diabetes management, symptom recognition, emergency procedures, and day-to-day support for children with type 1 diabetes in educational settings. Unlike standard informational sessions or general health education, this intervention is tailored to address the unique challenges and responsibilities faced by school and kindergarten staff. The program is delivered in-person by certified diabetes educators and includes pre- and post-training assessments to measure changes in knowledge, perceptions, and attitudes. Participants are tracked using unique codes to allow for longitudinal comparison of results before, immediately after, and three months following the intervention.
No Intervention: Control Group - No Intervention
Participants in the control group did not receive any educational program or intervention. They completed the same questionnaire as the intervention group at baseline and again 3 months later. This allowed for comparison of changes in perceptions, knowledge, and attitudes about type 1 diabetes care without exposure to the educational intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the perception, knowledge, and attitudes of educational staff regarding the care of children with type 1 diabetes
Time Frame: Before the educational program Immediately after the educational program The entire study is scheduled to be conducted over a period of 10 months

Primary Outcome:

The primary outcome will be assessed by measuring the difference in the total score on a comprehensive, structured questionnaire designed to evaluate the perception, knowledge, and attitudes of educational staff regarding the care of children with type 1 diabetes. The questionnaire is administered before and immediately after participation in the educational program, as well as three months post-intervention. The objective is to quantify the immediate and sustained effects of the intervention on participants' understanding and preparedness to support children with type 1 diabetes in educational settings.

Time Frame:

Assessment will be conducted at three time points: prior to the start of the educational program (baseline) immediately after completion of the program.

Instrument:

The instrument used is a structured questionnaire specifically developed for this study. It is a compilation of seven previously validated instruments
Before the educational program Immediately after the educational program The entire study is scheduled to be conducted over a period of 10 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustainability of Changes in Knowledge, Perception, and Attitudes
Time Frame: Three months after completion of the educational program

This outcome will assess the sustainability of changes in educational staff's knowledge, perceptions, and attitudes regarding the care of children with type 1 diabetes. The difference in total scores on the same structured questionnaire will be measured three months after the educational program, compared to both baseline and immediate post-intervention results. This analysis aims to determine whether the improvements observed immediately after the intervention are maintained over time, indicating lasting impact of the educational program on participants' competencies and attitudes.

Instrument:

The same structured questionnaire developed specifically for this study, which is a compilation of seven previously validated instruments covering all relevant aspects of diabetes care in educational settings. This tool has undergone expert review and pilot testing to ensure its validity and reliability within the target population.
Three months after completion of the educational program

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sibenik University of Applied Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

August 22, 2025

First Submitted That Met QC Criteria

August 22, 2025

First Posted (Estimated)

August 29, 2025

Study Record Updates

Last Update Posted (Estimated)

September 8, 2025

Last Update Submitted That Met QC Criteria

August 29, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SibenikU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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