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NCT Number: NCT04888780

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

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.

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Key information

Conditions

Mental Disorder in Adolescence Autoimmune Diseases Behavior Behavioral Symptoms Child Behavior Depression Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Problem Behavior

Age range

11 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Adiyaman University Research Hospital

Adıyaman, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

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

Other

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 outcomes

  1. Children's Depression Inventory (CDI)

    Time frame: 5 minutes

    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)

  2. Paediatric Quality of Life Inventory (PedsQL)

    Time frame: 5 minutes

    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)

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

    Time frame: 2 minutes

    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.

Sponsors and collaborators

Lead sponsor

Gaziantep Islam Science and Technology University

Other

Collaborators

  • Adiyaman University Research Hospital

Registry information

Official study title

Gaziantep Islamic University of Science and Technology

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
May 17, 2021
Registry last updated
May 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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