The Effect of the Use of Computer Game- "My Diabetic Friend" in Children With Type 1 Diabetes
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Type 1 Diabetes |
Behavioral: Interactive computer game Behavioral: Convertible PC |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | 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. |
- Quality of life [ Time Frame: After 12 weeks (end of study) ] [ Designated as safety issue: No ]Quality of life questionnaires will be completed
- Metabolic control [ Time Frame: After 12 weeks (end of study) ] [ Designated as safety issue: No ]HbA1c will be measured
- Diabetes knowledge [ Time Frame: After 12 weeks ] [ Designated as safety issue: No ]Diabetes knowledge questionnaires will be completed
- Patient's gaming duration [ Time Frame: After 12 weeks ] [ Designated as safety issue: No ]The frequency and the duration of use of the interactive computer game by each participant will be monitored by the study team
- Compliance to diabetes treatment [ Time Frame: After 12 weeks ] [ Designated as safety issue: No ]Patient's parents will undergo clinical interview about patient's diabetes adherence
- Average glucose levels [ Time Frame: After 12 weeks (end of study) ] [ Designated as safety issue: No ]
- Average number of blood glucose measurements [ Time Frame: After 12 weeks (end of study) ] [ Designated as safety issue: No ]
- Measurements within normal range [ Time Frame: After 12 weeks (end of study) ] [ Designated as safety issue: No ]
- Hypoglycemia events [ Time Frame: After 12 weeks (end of study) ] [ Designated as safety issue: No ]
- Hyperglycemia events [ Time Frame: After 12 weeks (end of study) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: interactive computer game
Participants will be using the interactive computer game- "My Diabetic Friend", installed on Intel-powered convertible classmate PC.
|
Behavioral: Interactive computer game
Participants will use the interactive computer game installed on a convertible PC
|
|
Active Comparator: Convertible PC
Participants will be using the convertible classmate PC without the interactive computer game
|
Behavioral: Convertible PC
Participants will be using the convertible PC without the interactive computer game
|
Eligibility| Ages Eligible for Study: | 7 Years to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Rabin Medical Center |
| ClinicalTrials.gov Identifier: | NCT01600664 History of Changes |
| Other Study ID Numbers: | rmc006814ctil |
| Study First Received: | May 16, 2012 |
| Last Updated: | January 2, 2013 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Rabin Medical Center:
|
Type 1 diabetes "My Diabetic friend" interactive computer game |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013