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

Not Applicable

Not yet recruiting

• Conditions: Diabetic Pediatric Patients With Type 1 Diabetes
• Interventions: Device: educational game

• Registration Number: NCT05697484
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-01
• Study Start: 2023-01
• Study First Submitted: 2023-01-14
• Study First Submitted QC: 2023-01-14
• Last Update Submitted: 2023-01-14
• Study First Posted: 2023-01-26
• Last Update Posted: 2023-01-26
• Primary Completion: 2023-04
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

1. Pediatric patients age from 7 to 14 years old to be able to deal with and understand the game.
2. Children previously diagnosed with type1 DM.
3. Arabic speaker.
4. Smart phone (android) access at home, either the mobile of the child or his/her parents.

Exclusion Criteria

1. 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
2. Diabetic pediatric patients at goal with HbA1c < 7.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	educational game	-

Primary Outcome Measures

Name	Time	Method
diabetes control	3 months	diabetes control that will be assessed by measuring the HbA1c level at baseline and at the end of the study in both groups

Secondary Outcome Measures

Name	Time	Method
Measurement of blood glucose control	3 months	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.
Usability and satisfaction	3 months	Usability and satisfaction of the patients will be assessed using a 10-item Arabic System Usability Scale (A-SUS) for mobile applications.
Behavioral change	3 months	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.