Disease Management in Adolescents With Type 1 Diabetes

NCT06246279 | Completed DMC

• 1 other identifier: AdolescentswithType1Diabete
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Keywords

Type 1 Diabetes; Transition Theory; Diabetes Management; Pediatric Nurse; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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 was administered three times at beginning, 3rd and 6th months.

Secondary Outcomes (2)

• Diabetes Management Self-Efficacy Scale in Adolescents with Type 1 Diabetes

  This scale was administered three times at beginning, 3rd and 6th months.

• Glycemic Control - Hemoglobin A1C

  This scale was administered three times at beginning, 3rd and 6th months.

Study Arms (2)

Experimental group

EXPERIMENTAL

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.

Behavioral: Adaptation to Adolescence and Type 1 Diabetes Management Training Program

Control group

NO INTERVENTION

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

Interventions

Adaptation to Adolescence and Type 1 Diabetes Management Training Program 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.

Experimental group

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz Univercity

Antalya, 07100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Adolescent Behavior; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Behavior; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ceren Calik

  Akdeniz Univercity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master of Science, specialist nurse

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 7, 2024
• Study Start: April 1, 2022
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)