The Impact of Arabic Gamified Mobile Application on Diabetes Control in Egyptian Pediatric Patients With Type 1 Diabetes.

Study Overview
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Brief Summary
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This is a prospective randomized parallel two group pharmacist-led interventional study. The study will involve introduction of the mobile game to pediatric diabetic patients to improve their blood glucose level. The outcomes to be measured are diabetes control and behavioral change in pediatric patients with type1 diabetes mellitus

Official Title
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The Impact of Arabic Gamified Mobile Application on Diabetes Control in Egyptian Pediatric Patients With Type 1 Diabetes.

Conditions
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Diabetic Pediatric Patients With Type 1 Diabetes

Intervention / Treatment
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* Device: educational game


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric patients age from 7 to 14 years old to be able to deal with and understand the game. Children previously diagnosed with type1 DM. Arabic speaker. Smart phone (android) access at home, either the mobile of the child or his/her parents. Exclusion Criteria: Severe cognitive or psychiatric conditions that prevent a patient from understanding the game. any disorder that significantly impairs the cognitive function of an individual to the point where normal functioning in society is impossible without treatment ,examples: dementia- developmental disorders-motor skills disorders- amnesia- substance induced cognitive impairment)25 Diabetic pediatric patients at goal with HbA1c < 7.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intervention group<br> | Device: educational game<br>* Control group will be provided with usual care. Intervention group will be provided in addition to the usual care, an access to the mobile game after a simple training for game usage. Both groups will be followed for a period of 3 months. The mobile game is planned to have the following design: Game will be presented in Arabic language. The game will consist of four levels. a. At the beginning of each level there will be an educational video that the patient must watch in order to be allowed to start the level.<br>|
| No Intervention: control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diabetes control | diabetes control that will be assessed by measuring the HbA1c level at baseline and at the end of the study in both groups | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioral change | The disease care activities of pediatric diabetic patients will be measured at baseline and at the end of the study after 3 months using The Arabic Summary of Diabetes Self-Care Activities measure. | 3 months | 
| Measurement of blood glucose control | the random blood glucose level of pediatric patients will be measured by themselves or by their parents on daily basis using glucometer and the reading will be recorded until next visit. | 3 months | 
| Usability and satisfaction | Usability and satisfaction of the patients will be assessed using a 10-item Arabic System Usability Scale (A-SUS) for mobile applications. | 3 months |