Constructed Intervention by Home and School Diabetes Nurse Visits on Diabetic Control of Children With Type I Diabetes
This study is not yet open for participant recruitment.
Verified June 2011 by Soroka University Medical Center
Sponsor:
Soroka University Medical Center
Collaborator:
Clalit Health Services
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT01382459
First received: June 23, 2011
Last updated: June 24, 2011
Last verified: June 2011
| Tracking Information | |||||||||
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| First Received Date ICMJE | June 23, 2011 | ||||||||
| Last Updated Date | June 24, 2011 | ||||||||
| Start Date ICMJE | July 2011 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT01382459 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Constructed Intervention by Home and School Diabetes Nurse Visits on Diabetic Control of Children With Type I Diabetes | ||||||||
| Official Title ICMJE | The Efficacy of Constructed Intervention by Home and School Visits by Diabetes Nurses on Diabetic Control of Children With Type I Diabetes | ||||||||
| Brief Summary | The investigators assume that an intervention program that includes home visits and trainings of diabetes' nurse and dietitian will lead to an improvement of the patients' metabolic balance, a decrease in complications' rate, a reduction of hospitalizations and an economic streamlining. |
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| Detailed Description | The investigators assume that during the study, subjects from the intervention group will reach a better metabolic balance than the control group. In this group the following changes will occur:
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | type 1 DM children in the age of 4-18, living in Beer Sheva and the area, who are under treatment in the pediatric diabetes unit in Soroka. |
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| Condition ICMJE | Type 1 Diabetes Mellitus | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||
| Completion Date | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: - Children who are not in educational settings and are not hebrew or arabic speakers. |
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| Gender | Both | ||||||||
| Ages | 4 Years to 18 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01382459 | ||||||||
| Other Study ID Numbers ICMJE | sor517111ctil | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Prof. Eli Hershkovitz, Pediatric endocrinology and diabetes unit | ||||||||
| Study Sponsor ICMJE | Soroka University Medical Center | ||||||||
| Collaborators ICMJE | Clalit Health Services | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Soroka University Medical Center | ||||||||
| Verification Date | June 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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