## Protocol Section
### Identification Module
**NCT ID:** NCT06246279

**Brief Title:** Disease Management in Adolescents With Type 1 Diabetes

**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

#### Organization Study ID Info
**ID:** AdolescentswithType1Diabete
#### Organization
**Class:** OTHER
**Full Name:** Akdeniz University
### Status Module
#### Completion Date
**Date:** 2024-06-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-02-08

**Type:** ACTUAL

**Last Update Submit Date:** 2024-02-06

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-12-01

**Type:** ACTUAL

**Status Verified Date:** 2024-02

#### Study First Post Date
**Date:** 2024-02-07
**Type:** ACTUAL
**Study First Submit Date:** 2024-01-30
**Study First Submit QC Date:** 2024-01-30
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Akdeniz University

#### Responsible Party

**Investigator Affiliation:** Akdeniz University

**Investigator Full Name:** Ceren Calik

**Investigator Title:** Master of Science, specialist nurse

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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 Module

**Conditions:**

- type1diabetes

- Adolescent Behavior

- Self Efficacy

**Keywords:**

- Type 1 Diabetes

- Transition Theory

- Diabetes Management

- Pediatric Nurse

- Randomized Controlled Trial

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

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

**Label:** Experimental group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The routinely planned diabetes education of the institution will be given by the training nurse.

**Label:** Control group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Experimental group

**Description:** 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.

**Name:** Adaptation to Adolescence and Type 1 Diabetes Management Training Program

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Reynolds Adjustment Screening Inventory for Adolescents

**Time Frame:** This scale will be applied three times at beginning, 3rd and 6th months.

#### Secondary Outcomes

**Description:** 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.

**Measure:** 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.

**Description:** 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.

**Measure:** Glycemic Control - Hemoglobin A1C

**Time Frame:** This scale will be applied three times at beginning, 3rd and 6th months.

### Eligibility Module

**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

**Maximum Age:** 18 Years

**Minimum Age:** 12 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** cerencalik@yahoo.com.tr

**Name:** Ceren Calik

**Phone:** +90 507 606 0057

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Antalya

**Contacts:**

***Contact 1:***

- **Email:** cerencalik@yahoo.com.tr

- **Name:** Ceren Calik

- **Phone:** +90 507 606 0057

- **Role:** CONTACT

**Country:** Turkey

**Facility:** Akdeniz Univercity

**Status:** RECRUITING

**Zip:** 07100

#### Overall Officials

**Official 1:**

**Affiliation:** Akdeniz Univercity

**Name:** Ceren Calik

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes

- ID: M7117

- Name: Diabetes Mellitus, Type 1

- Relevance: HIGH

- As Found: Type 1 Diabetes

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000003922

- Term: Diabetes Mellitus, Type 1

### Misc Info Module

- Version Holder: 2024-05-24
