The Effect of the Use of Computer Game- "My Diabetic Friend" in Children With Type 1 Diabetes
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.
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2012
CompletedFirst Posted
Study publicly available on registry
May 17, 2012
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedMay 6, 2014
May 1, 2014
1.2 years
May 16, 2012
May 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of life
Quality of life questionnaires will be completed
After 12 weeks (end of study)
Secondary Outcomes (9)
Metabolic control
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
Average glucose levels
After 12 weeks (end of study)
- +4 more secondary outcomes
Study Arms (2)
interactive computer game
EXPERIMENTALParticipants will be using the interactive computer game- "My Diabetic Friend", installed on Intel-powered convertible classmate PC.
Convertible PC
ACTIVE COMPARATORParticipants will be using the convertible classmate PC without the interactive computer game
Interventions
Participants will use the interactive computer game installed on a convertible PC
Participants will be using the convertible PC without the interactive computer game
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rabin Medical Centerlead
- Intel Corporationcollaborator
Study Sites (1)
Schneider Medical Center
Petah Tikva, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Moshe Phillip, Prof
Rabin Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2012
First Posted
May 17, 2012
Study Start
June 1, 2012
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
May 6, 2014
Record last verified: 2014-05