Schneider Medical Center
Petah Tikva, Israel
NCT Number: NCT01600664
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;
1. 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. 2. 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.
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Notify Me7 year–11 year
All sexes
Interventional
Not applicable
Petah Tikva, Israel
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will use the interactive computer game installed on a convertible PC
Participants will be using the convertible PC without the interactive computer game
Time frame: After 12 weeks (end of study)
Quality of life questionnaires will be completed
Time frame: After 12 weeks (end of study)
HbA1c will be measured
Time frame: After 12 weeks
Diabetes knowledge questionnaires will be completed
Time frame: After 12 weeks
The frequency and the duration of use of the interactive computer game by each participant will be monitored by the study team
Time frame: After 12 weeks
Patient's parents will undergo clinical interview about patient's diabetes adherence
Time frame: After 12 weeks (end of study)
Time frame: After 12 weeks (end of study)
Time frame: After 12 weeks (end of study)
Time frame: After 12 weeks (end of study)
Time frame: After 12 weeks (end of study)
Rabin Medical Center
Other
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.
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