Randomized Controlled Trial to Evaluate the Effect of 3 Months Use With Interactive Computer Game- "My Diabetic Friend"-Comparing to Conventional Diabetes Education on Metabolic Control, Quality of Life and Diabetes Knowledge in Children With Type 1 Diabetes.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Quality of life
研究概览
简要总结
A randomized controlled study to evaluate the effect of 3 months use with interactive computer game- "My Diabetic Friend"- comparing to conventional diabetes education on metabolic control, quality of life and diabetes knowledge.Patients will be randomized into two groups- one group will be supplied with interactive computer game, "My Diabetic friend", installed on a computer designed for children's educational needs for a period of three months and the other group will be supplied with the same computer without the interactive computer game for three months. Metabolic control, quality of life and diabetes knowledge will be evaluated before and after the use of the computer.
The trial is consisting of two main periods: 3 months of the main study period and an optional extension period consisting of the following 3 months :
The study will include two main periods;
- Period 1 which will last 3 months, in a randomized controlled manner, this period will serve as the main study period to assess the primary and secondary endpoints of the study.
- Period 2: this extension period will not be an integral part of the study, and only patients who are willing will take part at this period, will continue to participate at the optional extension period. During the extension period, patients in the intervention group will be offered to continue the use of the Computer game -"My diabetic friend) for the following 3 months, and patients who participated at the control group during period 1, will be offered to start to use the Computer Game - "My Diabetic Friend" for the following 3 months.
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
- None
入排标准
- 年龄范围
- 7 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes diagnosed at least one year prior to study entry.
- •Age:7-11 years old.
- •Treatment either with CSII or MDI.
- •HbA1c>8.0%
- •Signing an informed consent form.
排除标准
- •Any significant disease or conditions, including psychiatric disorders that in the opinion of the investigator are likely to affect subject compliance or subject's ability to complete the study.
- •Inability to understand/ complete the questionnaires.
研究组 & 干预措施
interactive computer game
Participants will be using the interactive computer game- "My Diabetic Friend", installed on Intel-powered convertible classmate PC.
干预措施: Interactive computer game (Behavioral)
Convertible PC
Participants will be using the convertible classmate PC without the interactive computer game
干预措施: Convertible PC (Behavioral)
结局指标
主要结局
Quality of life
时间窗: After 12 weeks (end of study)
Quality of life questionnaires will be completed
次要结局
- Average glucose levels(After 12 weeks (end of study))
- Metabolic control(After 12 weeks (end of study))
- Average number of blood glucose measurements(After 12 weeks (end of study))
- Measurements within normal range(After 12 weeks (end of study))
- Hypoglycemia events(After 12 weeks (end of study))
- Hyperglycemia events(After 12 weeks (end of study))
- Diabetes knowledge(After 12 weeks)
- Patient's gaming duration(After 12 weeks)
- Compliance to diabetes treatment(After 12 weeks)