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Effects of Web-Based Training on HbA1c, Quality of Life and Depression Levels in Adolescents With Type 1 Diabetes

Primary Purpose

Mental Disorder in Adolescence, Behavioral Symptoms, Problem Behavior

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

The web-based Watson's Human Care Theory oriented training

About this trial

This is an interventional supportive care trial for Mental Disorder in Adolescence focused on measuring Depression, Quality of life, Type 1 diabetes, Web-based training

Eligibility Criteria

11 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Internet access in the home environment,
Having a computer in the home environment and being able to use a person from the child and / or family,
Adolescent diagnosed with T1 DM at least 6 months ago,
Adolescent's ability to understand information, read and write in Turkish, and have no problems preventing him from communicating verbally,
Agreeing to sign the consent form that the family agreed to participate in the study,

Exclusion Criteria:

The patients, whose families did not agree to participate in the research for various reasons,
Internet not access in the home environment,
Adolescent has a chronic disease other than T1 DM,
Adolescent newly diagnosed with T1 DM,

Sites / Locations

Adiyaman University Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experiment adolescent group

Control adolescent group

Arm Description

The web-based Watson's Human Care Theory oriented training and support program are applied to the intervention group.

No intervention is applied to the control group.

Outcomes

Primary Outcome Measures

Children's Depression Inventory (CDI)

CDI was developed by Kovacs in order to determine the severity of depression in children. The inventory was developed by using a language that could be easily understood by children and adolescents in ages from 6 to 17 years. It was adapted into Turkish by Öy (1990).It consists of 27 items. In each item, there are three sentences between which child or adolescent can choose by considering her/his two weeks before the application.Scores ranging from 0-2 are given to the answers given. High scores indicate the level of depression, and the highest score that can be obtained from the scale is 54. The cut-off point of the scale is 19.(Cronbach's alpha = 0.86)

Paediatric Quality of Life Inventory (PedsQL)

The Inventory was developed by Varni et al. (2003). It measures the quality of life both generally and specific to the disease. PedsQL was adapted into Turkish by Ayar and is the only type of quality of life inventory that includes scales both for the child and the parent. The inventory consists of 28 items and is divided into 5 sub-scales; which are diabetes symptoms comprising 11 items, treatment barriers comprising 4 items, treatment adherence comprising 7 items, worry comprising 3 items, and communication comprising 3 items. The high total score obtained from the scale indicates that the health-related quality of life is good. (Cronbach's alpha = 0.95)

Quality Criteria for Consumer Health Information (DISCERN) Website Evaluation Scale

DISCERN instrument; which was developed by Charnock et al. (1997) and adapted into Turkish in our country by Gokdogan and et al. (2003) was used in the research. The guide to the DISCERN quality criteria is used in order to evaluate the quality and reliability of the written materials that present health-related information. The instrument consists of 16 questions in total. The first 8 questions (1-8) in the guide evaluate the reliability of the presented information; the next 7 questions (9-15) evaluate the quality of the information about treatment and care, and the last question (16) evaluates the material in general. Each question is given a score of 1-5 (5: available, 1: unavailable).A total of 15 points indicate that the web page prepared is low in terms of information quality, and 75 points indicate high information quality.

Secondary Outcome Measures

Full Information

NCT ID

NCT04888780

First Posted

May 7, 2021

Last Updated

May 11, 2021

Sponsor

Gaziantep Islam Science and Technology University

Collaborators

Adiyaman University Research Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04888780

Brief Title

Effects of Web-Based Training on HbA1c, Quality of Life and Depression Levels in Adolescents With Type 1 Diabetes

Official Title

Gaziantep Islamic University of Science and Technology

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

January 1, 2017 (Actual)

Primary Completion Date

December 1, 2017 (Actual)

Study Completion Date

May 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Gaziantep Islam Science and Technology University

Collaborators

Adiyaman University Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Objective: This study was conducted to determine the effect of diabetes training on HbA1c, levels of depression and quality of life of Type 1 Diabetes Mellitus adolescents by using the Web-Based Watson Human Care Model. Methods: The study was conducted with 30 adolescents between 11-18 years old who was followed by Child Endocrinology Department and who accepted to participate in the research. A web page was developed by considering Training Guide for Adolescents with Type 1 Diabetes and processes of Watson Human Care Theory. Live video interviews were done with adolescents in the experiment group on 14 sessions and these interviews were recorded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mental Disorder in Adolescence, Behavioral Symptoms, Problem Behavior

Keywords

Depression, Quality of life, Type 1 diabetes, Web-based training

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

The research had an experimental design with pre-test and post-test control groups. The participants were randomly assigned to the experimental and control groups.

Masking

Participant

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experiment adolescent group

Arm Type

Experimental

Arm Description

The web-based Watson's Human Care Theory oriented training and support program are applied to the intervention group.

Arm Title

Control adolescent group

Arm Type

No Intervention

Arm Description

No intervention is applied to the control group.

Intervention Type

Other

Intervention Name(s)

The web-based Watson's Human Care Theory oriented training

Intervention Description

Video calls were held every 15 days via the skype program with complete adherence to the schedule. In these interviews, the clinical picture of diabetes and the psychosocial status of adolescents were discussed. A total of 14 interviews with 15-day intervals were made with each adolescent. All video interviews were carried out by the first researcher and they were all recorded.

Primary Outcome Measure Information:

Title

Children's Depression Inventory (CDI)

Description

Time Frame

5 minutes

Title

Paediatric Quality of Life Inventory (PedsQL)

Description

Time Frame

5 minutes

Title

Quality Criteria for Consumer Health Information (DISCERN) Website Evaluation Scale

Description

Time Frame

2 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

11 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Internet access in the home environment, Having a computer in the home environment and being able to use a person from the child and / or family, Adolescent diagnosed with T1 DM at least 6 months ago, Adolescent's ability to understand information, read and write in Turkish, and have no problems preventing him from communicating verbally, Agreeing to sign the consent form that the family agreed to participate in the study, Exclusion Criteria: The patients, whose families did not agree to participate in the research for various reasons, Internet not access in the home environment, Adolescent has a chronic disease other than T1 DM, Adolescent newly diagnosed with T1 DM,

Facility Information:

Facility Name

Adiyaman University Research Hospital

City

Adıyaman

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

The article containing the results of the study conducted using the data of the participants is at the publishing stage.

Citations:

PubMed Identifier

30073784

Citation

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Results Reference

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Citation

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Citation

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Effects of Web-Based Training on HbA1c, Quality of Life and Depression Levels in Adolescents With Type 1 Diabetes

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