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Clinical Trials/NCT06246279
NCT06246279
Completed
Not Applicable

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

Akdeniz University1 site in 1 country58 target enrollmentStarted: April 1, 2022Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
58
Locations
1
Primary Endpoint
Reynolds Adjustment Screening Inventory for Adolescents

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
12 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Reynolds Adjustment Screening Inventory for Adolescents

Time Frame: This scale was administered 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.

Secondary Outcomes

  • Glycemic Control - Hemoglobin A1C(This scale was administered three times at beginning, 3rd and 6th months.)
  • Diabetes Management Self-Efficacy Scale in Adolescents with Type 1 Diabetes(This scale was administered three times at beginning, 3rd and 6th months.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ceren Calik

Master of Science, specialist nurse

Akdeniz University

Study Sites (1)

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