NCT04888780

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 17, 2021

Completed
Last Updated

May 17, 2021

Status Verified

May 1, 2021

Enrollment Period

11 months

First QC Date

May 7, 2021

Last Update Submit

May 11, 2021

Conditions

Mental Disorder in AdolescenceBehavioral SymptomsProblem Behavior

Keywords

DepressionQuality of lifeType 1 diabetesWeb-based training

Outcome Measures

Primary Outcomes (3)

  • 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)

    5 minutes

  • 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)

    5 minutes

  • 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.

    2 minutes

Study Arms (2)

Experiment adolescent group

EXPERIMENTAL

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

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

Control adolescent group

NO INTERVENTION

No intervention is applied to the control group.

Interventions

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

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.

Experiment adolescent group

Eligibility Criteria

Age11 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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,

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adiyaman University Research Hospital

Adıyaman, Turkey (Türkiye)

Location

Related Publications (16)

  • Karahan Okuroglu G, Ecevit Alpar S. Effect of Web-based diabetes training program on diabetes-related knowledge, attitudes, and skills of health professionals: A randomized controlled trial. Jpn J Nurs Sci. 2019 Apr;16(2):184-193. doi: 10.1111/jjns.12228. Epub 2018 Aug 2.

    PMID: 30073784RESULT

  • Jaser SS. Family interaction in pediatric diabetes. Curr Diab Rep. 2011 Dec;11(6):480-5. doi: 10.1007/s11892-011-0222-y.

    PMID: 21853415RESULT

  • Charalampopoulos D, Hesketh KR, Amin R, Paes VM, Viner RM, Stephenson T. Psycho-educational interventions for children and young people with Type 1 Diabetes in the UK: How effective are they? A systematic review and meta-analysis. PLoS One. 2017 Jun 30;12(6):e0179685. doi: 10.1371/journal.pone.0179685. eCollection 2017.

    PMID: 28665946RESULT

  • Muscatello MR, Troili GM, Pandolfo G, Mento C, Gallo G, Lanza G, Pintaudi B, Di Vieste G, Di Benedetto A, Zoccali RA, Bruno A. [Depression, anxiety and anger in patients with type 1 diabetes mellitus.]. Recenti Prog Med. 2017 Feb;108(2):77-82. doi: 10.1701/2636.27098. Italian.

    PMID: 28287201RESULT

  • McGuire HC, Ji L, Kissimova-Skarbek K, Whiting D, Aguirre F, Zhang P, Lin S, Gong C, Zhao W, Lu J, Guo X, Ji Y, Seuring T, Hong T, Chen L, Weng J, Zhou Z. Type 1 diabetes mellitus care and education in China: The 3C study of coverage, cost, and care in Beijing and Shantou. Diabetes Res Clin Pract. 2017 Jul;129:32-42. doi: 10.1016/j.diabres.2017.02.027. Epub 2017 Feb 28.

    PMID: 28500868RESULT

  • Bentzen SM, Knudsen VK, Christiensen T, Ewers B. Relative validity of a web-based food frequency questionnaire for patients with type 1 and type 2 diabetes in Denmark. Nutr Diabetes. 2016 Sep 26;6(9):e232. doi: 10.1038/nutd.2016.40.

    PMID: 27669176RESULT

  • Avdal EU, Kizilci S, Demirel N. The effects of web-based diabetes education on diabetes care results: a randomized control study. Comput Inform Nurs. 2011 Feb;29(2):101-6. doi: 10.1097/NCN.0b013e3181fcbdc6.

    PMID: 21099675RESULT

  • Knox ECL, Quirk H, Glazebrook C, Randell T, Blake H. Impact of technology-based interventions for children and young people with type 1 diabetes on key diabetes self-management behaviours and prerequisites: a systematic review. BMC Endocr Disord. 2019 Jan 10;19(1):7. doi: 10.1186/s12902-018-0331-6.

    PMID: 30630442RESULT

  • Goksen D, Atik Altinok Y, Ozen S, Demir G, Darcan S. Effects of carbohydrate counting method on metabolic control in children with type 1 diabetes mellitus. J Clin Res Pediatr Endocrinol. 2014;6(2):74-8. doi: 10.4274/Jcrpe.1191.

    PMID: 24932599RESULT

  • Bachle C, Lange K, Stahl-Pehe A, Castillo K, Holl RW, Giani G, Rosenbauer J. Associations between HbA1c and depressive symptoms in young adults with early-onset type 1 diabetes. Psychoneuroendocrinology. 2015 May;55:48-58. doi: 10.1016/j.psyneuen.2015.01.026. Epub 2015 Feb 7.

    PMID: 25720348RESULT

  • Mutlu EK, Mutlu C, Taskiran H, Ozgen IT. Association of physical activity level with depression, anxiety, and quality of life in children with type 1 diabetes mellitus. J Pediatr Endocrinol Metab. 2015 Nov 1;28(11-12):1273-8. doi: 10.1515/jpem-2015-0082.

    PMID: 26197465RESULT

  • Samardzic M, Tahirovic H, Popovic N, Popovic-Samardzic M. Health-related quality of life in children and adolescents with type 1 diabetes mellitus from Montenegro: relationship to metabolic control. J Pediatr Endocrinol Metab. 2016 Jun 1;29(6):663-8. doi: 10.1515/jpem-2015-0420.

    PMID: 27054599RESULT

  • Fredette J, Mawn B, Hood K, Fain J. Quality of Life of College Students Living With Type 1 Diabetes: A Qualitative View. West J Nurs Res. 2016 Dec;38(12):1595-1610. doi: 10.1177/0193945916651265. Epub 2016 May 25.

    PMID: 27230752RESULT

  • Demir G, Ozen S, Cetin H, Darcan S, Goksen D. Effect of Education on Impaired Hypoglycemia Awareness and Glycemic Variability in Children and Adolescents with Type 1 Diabetes Mellitus. J Clin Res Pediatr Endocrinol. 2019 May 28;11(2):189-195. doi: 10.4274/jcrpe.galenos.2019.2019.0009. Epub 2019 Jan 31.

    PMID: 30701953RESULT

  • Tektas P, Cam O. The Effects of Nursing Care Based on Watson's Theory of Human Caring on the Mental Health of Pregnant Women After a Pregnancy Loss. Arch Psychiatr Nurs. 2017 Oct;31(5):440-446. doi: 10.1016/j.apnu.2017.07.002. Epub 2017 Jul 11. No abstract available.

    PMID: 28927506RESULT

  • Arslan-Ozkan I, Okumus H, Buldukoglu K. A randomized controlled trial of the effects of nursing care based on Watson's Theory of Human Caring on distress, self-efficacy and adjustment in infertile women. J Adv Nurs. 2014 Aug;70(8):1801-12. doi: 10.1111/jan.12338. Epub 2013 Dec 22.

    PMID: 24372443RESULT

Related Links

MeSH Terms

Conditions

Behavioral SymptomsProblem BehaviorDepressionDiabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

BehaviorChild BehaviorDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 7, 2021

First Posted

May 17, 2021

Study Start

January 1, 2017

Primary Completion

December 1, 2017

Study Completion

May 1, 2018

Last Updated

May 17, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

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

Locations

TU(1)