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

NCT05923632 | Recruiting DMC

• 1 other identifier: AİBÜ-HEM-BA-01
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Type 1 Diabetes; Children, Only

Keywords

Type 1 Diabetes; Children; Digital Game; Metabolic Control; Self-efficacy; Life Quality

Outcome Measures

Primary Outcomes (1)

• Quality of Life Scale for Children with Type 1 Diabetes (PedsQL 3.0)

  The scale was developed by Varni et al in 2003. It consists of five sub-dimensions: diabetes symptoms, treatment barriers, adherence to treatment, anxiety, and communication. The scale was prepared in a five-point Likert type, and the child form of the scale was designed for 5-7 age groups, 8-12 age groups and 13-18 age groups. A high total score from the scale indicates a high health-related quality of life. The internal consistency coefficient of the original form of the scale was 0.71(Varni et al,2003). The Turkish validity and reliability study of the 8-12 age form of the scale was performed by Ayar(2012), and the Turkish validity and reliability study of the 13-18 age form was performed by Çövener Özçelik et al(2015). In the study, the Cronbach's alpha values of the scales were 0.83 for 8-12 years old, 0.90 for 13-18 years old. In the studies of Ayar and Öztürk(2016); The internal consistency coefficient of the quality of life scale in children with diabetes was found to be 0.80.

  30 minutes

Secondary Outcomes (1)

• Diabetes Management Self-Efficacy Scale in Adolescents with Type 1 Diabetes

  30 minutes

Study Arms (2)

Pediatric patients with type 1 diabetes

EXPERIMENTAL

By providing standard diabetes education before the digital game intervention, the child who enters the game will be asked to fill out 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 the children in the experimental group are informed about the digital game designed according to the Information-Motivation-Behavioral Skills Model (IIMB) 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 line with the follow-up, and reminders will be made.At the 12th and 15th weeks (3 and 6 weeks after the training), all the scales will be administered again.

Behavioral: Dijital Game and Health Education

Pediatric patients with type 1 diabetes receiving routine care

NO INTERVENTION

At the beginning of the study, standard diabetes education will be given, and they will be asked to fill out the Children with Type 1 Diabetes Information Form, the Quality of Life Scale for Children with Type 1 Diabetes, and the Diabetes Management Self-Efficacy Scale. All scales will be administered again in the 12th and 15th weeks from the beginning of the study.

Interventions

Dijital Game and Health Education BEHAVIORAL

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 line with their background follow-up and reminders will be made.

Pediatric patients with type 1 diabetes

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Having another chronic disease other than T1DM

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (2)

Bolu Abant İzzet Baysal Üniversitesi

Bolu, Turkey (Türkiye)

RECRUITING

Zonguldak Bülent Ecevit Üniversitesi

Zonguldak, 67600, Turkey (Türkiye)

RECRUITING

Related Publications (11)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 integral process and economic evaluation - the CASCADE study. Health Technol Assess. 2014 Mar;18(20):1-202. doi: 10.3310/hta18200.

  PMID: 24690402 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Johnson D, Deterding S, Kuhn KA, Staneva A, Stoyanov S, Hides L. Gamification for health and wellbeing: A systematic review of the literature. Internet Interv. 2016 Nov 2;6:89-106. doi: 10.1016/j.invent.2016.10.002. eCollection 2016 Nov.

  PMID: 30135818 BACKGROUND

• Martos-Cabrera MB, Membrive-Jimenez MJ, Suleiman-Martos N, Mota-Romero E, Canadas-De la Fuente GA, Gomez-Urquiza JL, Albendin-Garcia L. Games and Health Education for Diabetes Control: A Systematic Review with Meta-Analysis. Healthcare (Basel). 2020 Oct 14;8(4):399. doi: 10.3390/healthcare8040399.

  PMID: 33066372 BACKGROUND

• Nelson LA, Wallston KA, Kripalani S, LeStourgeon LM, Williamson SE, Mayberry LS. Assessing barriers to diabetes medication adherence using the Information-Motivation-Behavioral skills model. Diabetes Res Clin Pract. 2018 Aug;142:374-384. doi: 10.1016/j.diabres.2018.05.046. Epub 2018 Jun 4.

  PMID: 29879495 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Bedriye AK, Associate Prof.Dr.

  Bolu Abant İzzet Baysal University

  STUDY DIRECTOR

• Özgür Bahadır, Lecturer

  Zonguldak Bulent Ecevit University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bedriye AK, Associate Prof.Dr.

CONTACT

+905327633151; bedriye_ak@yahoo.com

Özgür BAHADIR, Lecturer

CONTACT

+905063589308; ozgursinanbahadir@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Who will be assigned to the experimental or control group will be determined by using the "https://www.randomizer.org/" site. Blinding will be done at the beginning of the research when assigning groups and in the statistics and reporting part. At the end of the study, measures will be taken to prevent bias in the measurement in the coding of the data and the evaluation of the statistician. The statistician will not be informed whether the groups are experiments or controls. To avoid bias in the evaluation of data; It is thought that the statistical analyzes of the coded data in the prepared database will be done by a statistics and operations expert independent of the researcher. Data entries will be entered with "A" and "B" codes without specifying the experimental or control group, and the analysis of the data will be done by coding as "A" and "B" groups. After the statistical analysis, the coding of the experimental and control groups will be explained.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assosiciate Prof. Dr.

Model Details: Parallel Assignment Randomized Controlled Trial

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: June 28, 2023
• Study Start: November 20, 2024
• Primary Completion: October 20, 2025
• Study Completion: December 30, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data wıll be collected for 4 month
• Access Criteria: Can be contacted through YOK-thesıs center

Locations

TU (2)