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

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05697484
Collaborator
(none)
76
2
11

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: educational game
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
76 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
The Impact of Arabic Gamified Mobile Application on Diabetes Control in Egyptian Pediatric Patients With Type 1 Diabetes.
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: intervention group

Device: 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: 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.

No Intervention: control group

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 14 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sara Mohammed Esmail Alsadek Sherif, Teaching Assistant at faculty of pharmacy, Cairo university, Cairo University
ClinicalTrials.gov Identifier:
NCT05697484
Other Study ID Numbers:
  • CL(3017)
First Posted:
Jan 26, 2023
Last Update Posted:
Jan 26, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 26, 2023