Metabolic Control Adolescents Type 1 Diabetes

The Effect of Education Including Peer Interactive Group Support on Metabolic Control ın Adolescents wıth Type One Diabetes a Randomized Controlled Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: 13-18 Year; Diagnosed at Least 6 Months Ago; HbA1C> 7.5; Being Able to Read and Write
• Intervention / Treatment: Behavioral: training sessions with peer interactive group

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Didem POLAT KÜLCÜ, PhD; Phone Number: 5066018023; Email: didem.kulcu@toros.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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" .
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implementation of trainings containing peer interactive group support to adolescents and application of scales	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 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.	7 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Data	The data obtained from the research were evaluated using appropriate statistical methods. In the analysis of comparative data, parametric or nonparametric tests were used by evaluating the conformity to the normal distribution . As descriptive statistics; numbers and percentages are given. In addition, mean and standard deviation values are given for those with normal distribution, and minimum and maximum values, median and percentiles of 25-75 % for those who do not show normal distribution.	one year

Collaborators and Investigators

• Sponsor: Toros University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 15, 2023
• Primary Completion (Anticipated): July 15, 2023
• Study Completion (Anticipated): July 15, 2023

Study Registration Dates

• First Submitted: October 7, 2022
• First Submitted That Met QC Criteria: March 30, 2023
• First Posted (Actual): April 13, 2023

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: metabolic control; nursing; Type 1 diabetes; adolescence
• Other Study ID Numbers: TorosU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: may be shared upon reasonable request from the author
• IPD Sharing Time Frame: 2024
• IPD Sharing Access Criteria: may be shared upon reasonable request from the author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No