The Effect Of Model-Based Dıgıtal Game On Metabolıc Control, Self-Effıcıency And Qualıty Of Lıfe In Chıldren Wıth Type 1 Dıabetes

Overview

This study was planned to determine the effect of model-based digital game on metabolic control, self-efficacy and quality of life in children with T1DM.

Detailed description

This study was planned to determine the effect of model-based digital game on metabolic control, self-efficacy and quality of life in children with T1DM. This study was planned as a randomized controlled trial with a pre-post test parallel group. Participants to be included in the study, In this study, children between the ages of 8-13 who were diagnosed with T1DM and followed up in the Pediatric Endocrinology outpatient clinics and services of two hospitals in two different centers will be selected. During the follow-up days of the children in the outpatient clinic, the diabetes nurse will be contacted to discuss working with the child with T1DM and their families. After the child and their parents are informed about the purpose and application of the study, that the collected data will only be used for scientific research purposes, the children and their families who gave their consent to participate in the study will be asked to sign the volunteering form. Children who agree to participate in the study will be given a password to log in to the created web page. Experimental and control groups will be determined according to the order of login with this password and randomization with https://www.randomizer.org/. Standard diabetes education was given to both groups before the game intervention to be applied to the experimental group; Children entering the site will be asked to fill in the Child with Type 1 Diabetes Descriptive Information Form, the Quality of Life in Children with Type 1 Diabetes Scale and the Diabetes Management Self-Efficacy Scale in Children with Type 1 Diabetes. After informing the children in the experimental group about the game designed based on The Information-Motivation-Behavioral Skills Model(IMB) of diabetes management on the website, it will be ensured that the children actively participate in the game for 9 weeks and their participation status in the background of the game will be followed; At the end of 9 weeks, all stages of the game will be required to be completed. Reminders will be made by contacting the children who have not completed the game in line with the follow-ups in the background, once a week. During this process, the control group; On a weekly basis, slides supported with visuals related to nutrition, exercise and drug use will be presented on the web page in the form of sessions. Children will be provided to watch each session. Whether the children complete the sessions or not will be monitored from the background. Children who do not complete the sessions will be reminded once a week.

All scales will be re-administered to both groups at the 12th week (3 weeks after the training). Scales will also be applied through the website. HbA1c and other blood levels of the parameters to be used in the study will be obtained from the hospital files at the beginning of the study and at the end of the 12th week, as they are routinely requested during the controls. At the end of the study, the control group will also be allowed to log in to the game via the website in terms of ethical compliance.

Interventions

• Behavioral Dijital Game and Health Education
  After the children in the experimental group are informed about the digital game designed according to The The Information-Motivation-Behavioral Skills Model (IMB) in diabetes management, active participation of the children in the digital game will be ensured for 9 weeks; and participation status will be followed in the background of the game. At the end of 9 weeks, children will be asked to complete all stages of the game. Children who do not complete the game will be contacted once a week in

Primary outcome measures

• Quality of Life Scale for Children with Type 1 Diabetes (PedsQL 3.0) [Time frame: 30 minutes]

Secondary outcome measures (1)

• Diabetes Management Self-Efficacy Scale in Adolescents with Type 1 Diabetes [Time frame: 30 minutes]

Eligibility criteria

Inclusion criteria

• Being in the 8-13 age range,
• Being diagnosed with T1DM at least 6 months ago,
• Ability to read and write Turkish,
• Ability to communicate verbally,
• To have Internet access,
• Computer, tablet, etc. to have and use technological tools,
• To volunteer to participate in the study

Exclusion criteria

• Having another chronic disease other than T1DM

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

Turkey (Türkiye) · 2 centers

• Bolu Abant İzzet Baysal Üniversitesi — Bolu
• Zonguldak Bülent Ecevit Üniversitesi — Zonguldak

Publications

• Varni JW, Burwinkle TM, Jacobs JR, Gottschalk M, Kaufman F, Jones KL. The PedsQL in type 1 and type 2 diabetes: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales and type 1 Diabetes Module. Diabetes Care. 2003 Mar;26(3):631-7. doi: 10.2337/diacare.26.3.631. PMID 12610013
• Nansel TR, Weisberg-Benchell J, Wysocki T, Laffel L, Anderson B; Steering Committee of the Family Management of Diabetes Study. Quality of life in children with Type 1 diabetes: a comparison of general and diabetes-specific measures and support for a unitary diabetes quality-of-life construct. Diabet Med. 2008 Nov;25(11):1316-23. doi: 10.1111/j.1464-5491.2008.02574.x. PMID 19046222
• Christie D, Thompson R, Sawtell M, Allen E, Cairns J, Smith F, Jamieson E, Hargreaves K, Ingold A, Brooks L, Wiggins M, Oliver S, Jones R, Elbourne D, Santos A, Wong IC, O'Neill S, Strange V, Hindmarsh P, Annan F, Viner R. Structured, intensive education maximising engagement, motivation and long-term change for children and young people with diabetes: a cluster randomised controlled trial with in PMID 24690402
• Brown SJ, Lieberman DA, Germeny BA, Fan YC, Wilson DM, Pasta DJ. Educational video game for juvenile diabetes: results of a controlled trial. Med Inform (Lond). 1997 Jan-Mar;22(1):77-89. doi: 10.3109/14639239709089835. PMID 9183781
• Gao J, Wang J, Zhu Y, Yu J. Validation of an information-motivation-behavioral skills model of self-care among Chinese adults with type 2 diabetes. BMC Public Health. 2013 Feb 4;13:100. doi: 10.1186/1471-2458-13-100. PMID 23379324
• Goncalves S, Barros V, Rui Gomes A. Eating-Disordered Behaviour in Adolescents with Type 1 Diabetes. Can J Diabetes. 2016 Apr;40(2):152-7. doi: 10.1016/j.jcjd.2015.09.011. Epub 2016 Feb 10. PMID 26874893
• Goyal S, Nunn CA, Rotondi M, Couperthwaite AB, Reiser S, Simone A, Katzman DK, Cafazzo JA, Palmert MR. A Mobile App for the Self-Management of Type 1 Diabetes Among Adolescents: A Randomized Controlled Trial. JMIR Mhealth Uhealth. 2017 Jun 19;5(6):e82. doi: 10.2196/mhealth.7336. PMID 28630037
• Holtz BE, Murray KM, Hershey DD, Dunneback JK, Cotten SR, Holmstrom AJ, Vyas A, Kaiser MK, Wood MA. Developing a Patient-Centered mHealth App: A Tool for Adolescents With Type 1 Diabetes and Their Parents. JMIR Mhealth Uhealth. 2017 Apr 19;5(4):e53. doi: 10.2196/mhealth.6654. PMID 28428167

Identifiers

NCT: NCT05923632 · AİBÜ-HEM-BA-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗