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

NCT05697484 | Unknown DMC

• 1 other identifier: CL(3017)
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

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

Conditions

Diabetic Pediatric Patients With Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Behavioral change

  3 months

• Measurement of blood glucose control

  3 months

• Usability and satisfaction

  3 months

Study Arms (2)

intervention group

ACTIVE COMPARATOR

Device: educational game

control group

NO INTERVENTION

Interventions

educational game DEVICE

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: 1. Game will be presented in Arabic language. 2. 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.

intervention group

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant at faculty of pharmacy, Cairo university

Study Record Dates

• First Submitted: January 14, 2023
• First Posted: January 26, 2023
• Study Start: January 1, 2023
• Primary Completion: April 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share