Disease Management in Adolescents With Type 1 Diabetes

NCT ID: NCT06246279

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2024-04-30

Brief 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.

Conditions

type1diabetes; Adolescent Behavior; Self Efficacy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Experimental group

In addition to the institution's routine T1DM training, the "Adjustment to Adolescence and Transition to Type 1 Diabetes Education Program" prepared in line with Meleis's Transition Theory was applied to adolescents online via the Microsoft Teams Program.

Group Type: EXPERIMENTAL

Adaptation to Adolescence and Type 1 Diabetes Management Training Program

Intervention Type: BEHAVIORAL

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.

Control group

The institution's routinely planned diabetes education was given by the pediatric diabetes education nurse.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akdeniz University

OTHER

Sponsor Role: lead

Responsible Party

Ceren Calik

Master of Science, specialist nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ceren Calik

Role: PRINCIPAL_INVESTIGATOR

Akdeniz Univercity

Locations

Akdeniz Univercity

Antalya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

AdolescentswithType1Diabete

Identifier Type: -

Identifier Source: org_study_id