Disease Management in Adolescents With Type 1 Diabetes

February 6, 2024 updated by: Ceren Calik, Akdeniz University

The Effect of the Education Program Prepared in Line With Transition Theory on Adaptation to Adolescence and Disease Management in Adolescents With Type 1 Diabetes: Randomized Controlled Study

Adolescence period; It is a transition period of rapid growth, development and maturation in biochemical, physical, social and spiritual terms, which lasts from the beginning of puberty to young adulthood. Adolescence is a predictable developmental transition period for the individual. They also encounter unpredictable situations (such as childhood illnesses). One of these conditions is Type 1 Diabetes Mellitus, which is the most common metabolic endocrine system disease in adolescents. Type 1 diabetes is an important health/disease transition in the life of a child and adolescent. Therefore, this study aimed to determine the effect of the "Adaptation to Adolescence and Type 1 Diabetes Management Training Programme", prepared in line with Meleis's Transition Theory, on the adolescent's developmental transition adaptation, self-efficacy for diabetes management and glycemic control.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

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 Contact

Study Locations

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Having been diagnosed with type 1 diabetes in the last 6 months
  • HbA1c level >7.5

Exclusion Criteria:

  • presence of a diagnosis of intellectual disability, autism spectrum disorder and psychotic disorder

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
In addition to the routine diabetes training of the institution, the "Adaptation to Adolescence and Type 1 Diabetes Management Training Program" prepared in line with Meleis's Transition Theory will be administered online to adolescents via Microsoft Teams Program in groups of 10 people, for a total of 10 sessions in 2 months.
Behavioral: Adaptation to Adolescence and Type 1 Diabetes Management Training Program
The content of the Training Program was created by researchers based on Transition Theory, in line with high-level research results and international guides. Then, the necessary arrangements were made by taking the opinions of 10 experts (child health and disease nursing faculty member, child and adolescent mental health specialist, child endocrinologist, child development specialist, nutrition and dietetics specialist, sports training specialist). The content was finalized in line with the comments received.
No Intervention: Control group
The routinely planned diabetes education of the institution will be given by the training nurse.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reynolds Adjustment Screening Inventory for Adolescents
Time Frame: This scale will be applied three times at beginning, 3rd and 6th months.
Reynolds Adjustment Screening Inventory has four subscales. These; emotional distress (10 items), antisocial behavior (8 items), positive self (6 items related to self-confidence and socialization) and anger control problems (8 items). The Cronbach alpha value of the scale is stated as 0.91. The lowest score of the scale is 32 and the highest score is 165.
This scale will be applied three times at beginning, 3rd and 6th months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetes Management Self-Efficacy Scale in Adolescents with Type 1 Diabetes
Time Frame: This scale will be applied three times at beginning, 3rd and 6th months.
The scale is used to determine the educational needs of adolescents or to evaluate the effectiveness of diabetes education programs. The scale consists of 26 items ranging from 1 (completely agree) to 5 (strongly disagree). The lowest total score that can be obtained from the scale is 26 and the highest is 130. A higher score indicates less self-efficacy. The Cronbach's alpha coefficient of the scale was found to be 0.85.
This scale will be applied three times at beginning, 3rd and 6th months.
Glycemic Control - Hemoglobin A1C
Time Frame: This scale will be applied three times at beginning, 3rd and 6th months.
Glycemic control was assessed by HbA1C level. In Type 1 Diabetes, Hb A1C level is one of the basic control parameters checked in the clinic in adolescents. It is repeated routinely every 3 months when the child comes to the outpatient clinic for control for Type 1 Diabetes.
This scale will be applied three times at beginning, 3rd and 6th months.

Collaborators and Investigators

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

Sponsor

Akdeniz University

Investigators

  • Principal Investigator: Ceren Calik, Akdeniz Univercity

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)

December 1, 2022

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

January 30, 2024

First Submitted That Met QC Criteria

January 30, 2024

First Posted (Actual)

February 7, 2024

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AdolescentswithType1Diabete

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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