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

NCT ID: NCT05697484

Last Updated: 2023-01-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-31
• Study Completion Date: 2023-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

intervention group

Group Type: ACTIVE_COMPARATOR

educational game

Intervention Type: 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.

control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

educational game

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 Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Sara Mohammed Esmail Alsadek Sherif

Teaching Assistant at faculty of pharmacy, Cairo university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

CL(3017)

Identifier Type: -

Identifier Source: org_study_id