Metabolic Control Adolescents Type 1 Diabetes

Sponsor

Toros University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05811078

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
13-18 Year Diagnosed at Least 6 Months Ago HbA1C> 7.5 Being Able to Read and Write	Behavioral: training sessions with peer interactive group	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

randomized controlling trailrandomized controlling trail

Masking:

Single (Participant)

Masking Description:

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.

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Apr 15, 2023

Anticipated Primary Completion Date :

Jul 15, 2023

Anticipated Study Completion Date :

Jul 15, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Implementation of trainings containing peer interactive group support to adolescents and application of scales [7 weeks]
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.

Secondary Outcome Measures

Evaluation of Data [one year]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Toros University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Didem Polat Kulcu, principle ınvestigator, Toros University

ClinicalTrials.gov Identifier:

NCT05811078

Other Study ID Numbers:

TorosU

First Posted:

Apr 13, 2023

Last Update Posted:

Apr 13, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Didem Polat Kulcu, principle ınvestigator, Toros University

Study Results

No Results Posted as of Apr 13, 2023