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

Behavioral Symptoms Clinical Trial

Official title:

Gaziantep Islamic University of Science and Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04888780
• Other study ID #: GaziantepIslamicUST
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: May 1, 2018

Study information

• Verified date: May 2021
• Source: Gaziantep Islamic University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 1, 2018
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

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,

Related Conditions & MeSH terms

• Behavioral Symptoms
• Mental Disorder in Adolescence
• Mental Disorders
• Problem Behavior

Intervention

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

Locations

Country	Name	City	State
Turkey	Adiyaman University Research Hospital	Adiyaman

Sponsors (2)

Lead Sponsor	Collaborator
Gaziantep Islamic University of Science and Technology	Adiyaman University Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (16)

Arslan-Özkan 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/ja — View Citation

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. — View Citation

Bächle 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. — View Citation

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. — View Citation

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 — View Citation

Demir G, Özen S, Çetin H, Darcan S, Göksen 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 — View Citation

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. Epub 2016 May 25. — View Citation

Göksen 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. — View Citation

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

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. — View Citation

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 — View Citation

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 Be — View Citation

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: 10.170 — View Citation

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. — View Citation

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: — View Citation

Tektas P, Çam 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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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

External Links

•   B.N.Ö. Uran, S. Ozer, Y. Yildirim, An example of Watson's theory of human caring model: case of heart failure. Turk J Card Nur. 6(11) (2015) 183-198. https://doi.org/10.5543/khd.2015.017.
•   C. Öztürk, D. Ayar, The importance of quality of life in children with type 1 diabetes mellitus, E-Journal of Dokuz Eylul University Nursing Faculty. 6(2) (2013) 99-101.
•   E. Duras, D. Bezen, O. Özkaya, H. Dursun, Evaluation of the quality of life patients followed up with diagnosis of type 1 diabetes mellitus, The Journal of Current Pediatrics. 16(2) (2018) 72-85.
•   J. Watson, Intentionality and caring-healing consciousness: a practice of transpersonal nursing. Holistic Nursing Prac. 16(4) (2002) 12-19.
•   K. Öner, H. Arslantas, Depression, internet addiction and related factors in adolescents of high school students, 6 th World Nursing and Healthcare Conference, August 15-16, 2016. London, United Kingdom..
•   N. Yalcin Atar, T. Atabek Asti, Validity and reliability of Turkish version of the caring nurse-patient interaction scale, Florence Nightingale Journal of Nursing. 20(2) (2012) 129-139.
•   S. Altundag, The effect of social support and education at adaptation to disease in children with type 1 diabetes mellitus, Pamukkale Medical Journal. 11(2) (2017) 137-144. https://doi.org/10. 5505/ptd.2017.90958.
•   S.A. Fitzgerald, V.E.M. Zavala, K.Y.R. Blanco, A.P. Cupertino, M.V. Geana, E.F. Ellerbeck, Acceptability and feasibility of web-based diabetes instruction for Latinos with limited education and computer experience, JHDRP. 9(3) (2016) 94-102.
•   Z. Karakus Er, Z. Özer, H. Boncuk, The effect of web based patient education on symptom management and quality of life of patients with diagnosed lung cancer. 1st International Health Sciences and Life Congress. 02-05 May, 2018. Burdur, Turkey