Assessment of an Alternative Model of Follow-up of Children and Adolescents With Type 1 Diabetes
| Tracking Information | |||||
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| First Received Date ICMJE | August 24, 2007 | ||||
| Last Updated Date | October 5, 2011 | ||||
| Start Date ICMJE | August 2005 | ||||
| Primary Completion Date | November 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Medical outcomes: HbA1c, rates of severe hypoglycemia, rates of DKA [ Time Frame: 1 year ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
Medical outcomes: HbA1c, rates of severe hypoglycemia, rates of DKA [ Time Frame: 1 year ] | ||||
| Change History | Complete list of historical versions of study NCT00521105 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Assessment of an Alternative Model of Follow-up of Children and Adolescents With Type 1 Diabetes | ||||
| Official Title ICMJE | Assessment of an Alternative Model Using Telemedicine Follow-up of Children and Adolescents With Type 1 Diabetes | ||||
| Brief Summary | The purpose of the study is to look at the effect of replacing the physician only visit by a transmission of information on the participant's current diabetes management and blood glucose monitoring results followed by a phone contact by the diabetes nurse educator. The study will also measure the effect on diabetes control (HbA1c), satisfaction with care, resource utilisation, and costs to the health care system and to the participant. We hypothesize that replacement of the physician-only visit by a virtual visit will not result in worsening of the medical outcomes and that it will result in a reduction in medical resources utilization and costs for families while increasing the satisfaction with care. |
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| Detailed Description | Improved metabolic control reduces both the onset and progression of diabetes-related complications in adults and adolescents with type 1 diabetes. Frequency of contact with the medical care team has been associated with better control. Both the American Diabetes Association and Canadian Diabetes Association recommend regular quarterly visits. However, the increase in case loads and the limited manpower available forces us to look at alternative models of care. A model of care in which medical visits alternate between a face to face multidisciplinary visits and a virtual visit done via fax or e-mail communication and a phone call may be advantageous to both the patient and the medical care team. For the patient and his family, this model would decrease time away from school and work, travel inconveniences and costs. For the medical care team it may decrease time per patient and therefore increase the number of patients served with the same resources. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
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| Condition ICMJE | Type 1 Diabetes Mellitus | ||||
| Intervention ICMJE | Other: Virtual visit
Participants will alternate between a multidisciplinary visit (MD, RN and RD) and a phone contact with the diabetes nurse educator (the phone contact will replace the physician-only visit). Prior to the phone contact, transmission of information from the participant will be sent through either fax or a web browser. |
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| Study Arm (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 | Completed | ||||
| Enrollment ICMJE | 82 | ||||
| Completion Date | November 2009 | ||||
| Primary Completion Date | November 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 1 Year to 17 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00521105 | ||||
| Other Study ID Numbers ICMJE | AR-2-05-1823-DP | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr. Danièle Pacaud, University of Calgary | ||||
| Study Sponsor ICMJE | University of Calgary | ||||
| Collaborators ICMJE | Canadian Diabetes Association | ||||
| Investigators ICMJE |
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| Information Provided By | University of Calgary | ||||
| Verification Date | October 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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