NCT05697484尚未招募不适用
The Impact of Arabic Gamified Mobile Application on Diabetes Control in Egyptian Pediatric Patients With Type 1 Diabetes.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 76
- 主要终点
- diabetes control
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 7 Years 至 14 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
intervention group
Active Comparator
干预措施: educational game (Device)
control group
No Intervention
结局指标
主要结局
diabetes control
时间窗: 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
次要结局
- Usability and satisfaction(3 months)
- Measurement of blood glucose control(3 months)
- Behavioral change(3 months)
研究者
Sara Mohammed Esmail Alsadek Sherif
Teaching Assistant at faculty of pharmacy, Cairo university
Cairo University
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