Metabolic Control Adolescents Type 1 Diabetes

NCT ID: NCT05811078

Last Updated: 2025-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-15

Study Completion Date

2023-07-15

Brief Summary

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Purpose of the research; The aim of this study is to examine the effect of education including peer-interactive group support to be given to adolescents diagnosed with Type 1 diabetes with poor glycemic control in the 13-18 age group on metabolic control of adolescents.

Detailed Description

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The lack of a certificate program specific to pediatric diabetes nursing of the Ministry of Health in our country and the insufficient number of diabetes education nurses show that the pediatric population is not adequately trained to provide diabetes management. Along with these obstacles, the lack of use of an evidence-based standard education program reveals the need for effective intervention programs that include approaches specific to adolescents, who are a particularly risky group. Peer interaction can be used as an effective approach to increase adolescents' adherence to treatment. Thus, adolescents who isolate themselves are given the opportunity to cope with the disease and to share with other children. It has been determined that there is no study in the literature that includes peer-interactive group support on adolescents with a diagnosis of Type 1 diabetes who have poor glycemic control but have repeated hospitalizations. This situation shows that there is a need for a study to evaluate the effect of educational intervention including peer-interactive group support on repeated hospitalizations in adolescents with Type 1 diabetes.

Conditions

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13-18 Year Diagnosed at Least 6 Months Ago HbA1C> 7.5 Being Able to Read and Write

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

randomized controlling trail
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
Adolescents who met the inclusion criteria of the study were listed and their names were written to someone who was not involved in the study. The adolescents included in the list formed by this person who was excluded from the study were randomly assigned to the experimental and control groups according to the block randomization method in order to eliminate the selection bias and to ensure the balance in the number of individuals between the groups. From here, all possible possibilities were created and the blocks were arranged so that there were 4 individuals (2 experiments, 2 controls) in each block. Each block was given a number and the assignment was made using the https://www.randomizer.org/ address.

Study Groups

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Enterprise Group

The contents of the research were created according to the Roy Adaptation model. Each session lasted an average of 2 hours.

Peer interactive group support sessions were administered to the adolescents in the intervention group, one week apart. There were 7 sessions in total. The sitting arrangement of the training room is designed to allow children to interact with each other . The sessions lasted an average of 90 minutes as two 45-minute sessions. Between sessions, breaks that lasted for about 15 minutes were given and refreshments prepared for individuals with Type 1 diabetes were served during the breaks. During the break, the adolescents were given the opportunity to interact with each other by chatting. Fun exercise and kitchen workshop activities were also organized as interaction sessions in the initiative group.

Group Type EXPERIMENTAL

training sessions with peer interactive group

Intervention Type BEHAVIORAL

Data were collected with data collection forms consisting of " Diabetes Adolescent Diagnosis Form", "Diabetes Information Evaluation Form", "Diabetes Management Self-Efficacy Scale in Adolescents with Type 1 Diabetes" and "Child's Attitude towards Own Disease Scale" .

Control Group

Adolescents and their families were informed in the diabetes education room in the pediatric endocrine service of the hospital where the study was conducted, and their written consent was obtained. Within the scope of the pre-test, "Diabetes Adolescent Diagnosis Form", "Diabetes Information Evaluation Form", "Diabetes Management Self-Efficacy Scale in Adolescents with Type 1 Diabetes" and "Child's Attitude towards Own Disease Scale" were applied. Then, individual diabetes education was given by the diabetes education nurse as a hospital routine. Three months after the training, the adolescents were called by phone to the hospital for control, HbA1c follow-up was taken and post-test applications were made.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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training sessions with peer interactive group

Data were collected with data collection forms consisting of " Diabetes Adolescent Diagnosis Form", "Diabetes Information Evaluation Form", "Diabetes Management Self-Efficacy Scale in Adolescents with Type 1 Diabetes" and "Child's Attitude towards Own Disease Scale" .

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* be between 13-18 years old
* Diagnosed at least 6 months ago
* HbA1C level \> 7.5
* Having repeated hospitalizations at least twice
* Living in Mersin city center
* Being able to communicate in Turkish
* Being able to read and write

Exclusion Criteria

* \- Using an insulin pump
* Having a chronic disease other than diabetes,
* Diseases that affect cognitive functions, hearing and vision impairments
Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Toros University

OTHER

Sponsor Role lead

Responsible Party

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Didem Polat Kulcu

principle ınvestigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Toros Üniversty

Mersin, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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TorosU

Identifier Type: -

Identifier Source: org_study_id

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