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

Primary Purpose

Type 1 Diabetes, Pediatric Nursing

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dijital Game and Health Education
Sponsored by
Abant Izzet Baysal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 1 Diabetes focused on measuring Self Management, Diabetes, Digital Game, Life Quality

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Being in the 8-18 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Pediatric patients with type 1 diabetes

    Pediatric patients with type 1 diabetes receiving routine care

    Arm Description

    By providing standard diabetes education before the digital game intervention the child who enters the game 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 the children in the experimental group are informed about the digital game designed according to the The Roy Adaptation Model(RAM) and 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 the followup and reminders will be made.At the 12th week(3 weeks after the training) all the scales will be administered again.

    At the beginning of the study, standard diabetes education will be given and they will be asked to fill in 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 week from the beginning of the study.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Diabetes Management Self-Efficacy Scale in Adolescents with Type 1 Diabetes
    It is a scale developed by Moens(1998). In the scale prepared according to the fivepoint Likert system, 1= yes definitely, 2= maybe yes, 3=maybe yes, maybe no, 4=maybe no, 5 = of course no. The perceived self-efficacy score is calculated by dividing the total number of items, and there is a negative correlation between the increase in the total score and the level of self-efficacy. Medical treatment and nutrition (1-2-4-5-7-9-10-11-14-18-22-26); adjustment of nutrition and insulin dose (6-8-12-13-17-19-21-25); being able to tell about diabetes (23-24); it consists of four sub-dimensions, being honest with oneself and others(3-15-16-20). The total explanatory variance rate of the four-factor scale is 47.1%. The reliability coefficient of the original scale; It is 0.8.The Turkish validity and reliability study was done by Öztürk, Ayar and Bektas(2016). The total Cronbach's alpha coefficient of the Turkish scale is 0.85, and its sub-dimensions are 0.80, 0.75, 0.70 and 0.70, respectively.

    Full Information

    First Posted
    May 5, 2023
    Last Updated
    June 27, 2023
    Sponsor
    Abant Izzet Baysal University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05923632
    Brief Title
    The Effect Of Model-Based Dıgıtal Game On Metabolıc Control, Self-Effıcıency And Qualıty Of Lıfe In Chıldren Wıth Type 1 Dıabetes
    Official Title
    The Effect Of Model-Based Dıgıtal Game On Metabolıc Control, Self-Effıcıency And Qualıty Of Lıfe In Chıldren Wıth Type 1 Dıabetes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2023 (Anticipated)
    Primary Completion Date
    April 1, 2024 (Anticipated)
    Study Completion Date
    December 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Abant Izzet Baysal University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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 8-18 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 Roy Adaptation Model(RAM) and 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 1 Diabetes, Pediatric Nursing
    Keywords
    Self Management, Diabetes, Digital Game, Life Quality

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Parallel Assignment Randomized Controlled Trial
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Pediatric patients with type 1 diabetes
    Arm Type
    Experimental
    Arm Description
    By providing standard diabetes education before the digital game intervention the child who enters the game 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 the children in the experimental group are informed about the digital game designed according to the The Roy Adaptation Model(RAM) and 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 the followup and reminders will be made.At the 12th week(3 weeks after the training) all the scales will be administered again.
    Arm Title
    Pediatric patients with type 1 diabetes receiving routine care
    Arm Type
    No Intervention
    Arm Description
    At the beginning of the study, standard diabetes education will be given and they will be asked to fill in 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 week from the beginning of the study.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Dijital Game and Health Education
    Intervention Description
    After the children in the experimental group are informed about the digital game designed according to The Roy Adaptation Model (RAM) and 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.
    Primary Outcome Measure Information:
    Title
    Quality of Life Scale for Children with Type 1 Diabetes (PedsQL 3.0)
    Description
    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.
    Time Frame
    30 minutes
    Secondary Outcome Measure Information:
    Title
    Diabetes Management Self-Efficacy Scale in Adolescents with Type 1 Diabetes
    Description
    It is a scale developed by Moens(1998). In the scale prepared according to the fivepoint Likert system, 1= yes definitely, 2= maybe yes, 3=maybe yes, maybe no, 4=maybe no, 5 = of course no. The perceived self-efficacy score is calculated by dividing the total number of items, and there is a negative correlation between the increase in the total score and the level of self-efficacy. Medical treatment and nutrition (1-2-4-5-7-9-10-11-14-18-22-26); adjustment of nutrition and insulin dose (6-8-12-13-17-19-21-25); being able to tell about diabetes (23-24); it consists of four sub-dimensions, being honest with oneself and others(3-15-16-20). The total explanatory variance rate of the four-factor scale is 47.1%. The reliability coefficient of the original scale; It is 0.8.The Turkish validity and reliability study was done by Öztürk, Ayar and Bektas(2016). The total Cronbach's alpha coefficient of the Turkish scale is 0.85, and its sub-dimensions are 0.80, 0.75, 0.70 and 0.70, respectively.
    Time Frame
    30 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Being in the 8-18 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bedriye AK, DR
    Phone
    05327633151
    Email
    bedriye_ak@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Özgür BAHADIR, Lecturer
    Phone
    05063589308
    Email
    ozgursinanbahadir@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Özgür Bahadır, Msc
    Organizational Affiliation
    Zonguldak Bulent Ecevit University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    We wıll prepare the study as a thesıs. Then we wıll turn ıt ınto a publıcatıon ın an ınternatıonal magazıne.
    IPD Sharing Time Frame
    Data wıll be collected for 3 month
    IPD Sharing Access Criteria
    Can be contacted through YOK-thesıs center
    Citations:
    PubMed Identifier
    12610013
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    19046222
    Citation
    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.
    Results Reference
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    PubMed Identifier
    24690402
    Citation
    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.
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    background
    PubMed Identifier
    9183781
    Citation
    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.
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    PubMed Identifier
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    Citation
    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.
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    PubMed Identifier
    26874893
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    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.
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    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.
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    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.
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    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.
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    Links:
    URL
    https://hdl.handle.net/20.500.12436/1629
    Description
    Psychometric evaluation of the pediatric quality of life inventory™ 3.0 diabetes module for Turkish children with type I diabetes mellitus

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

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