Disease Management in Adolescents With Type 1 Diabetes

Adolescent Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06246279
• Other study ID #: AdolescentswithType1Diabete
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: Akdeniz University
• Contact: Ceren Calik
• Phone: +90 507 606 0057
• Email: cerencalik[@]yahoo.com.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Behavior
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Self Efficacy
• type1diabetes

Intervention

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.

Locations

Country	Name	City	State
Turkey	Akdeniz Univercity	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reynolds Adjustment Screening Inventory for Adolescents	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	Diabetes Management Self-Efficacy Scale in Adolescents with Type 1 Diabetes	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.
Secondary	Glycemic Control - Hemoglobin A1C	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.