Assessment of an Alternative Model of Follow-up of Children and Adolescents With Type 1 Diabetes
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Assessment of an Alternative Model Using Telemedicine Follow-up of Children and Adolescents With Type 1 Diabetes|
- Medical outcomes: HbA1c, rates of severe hypoglycemia, rates of DKA [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Resource utilization: physicians, nurses, and dietitians, emergency room visits [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Family satisfaction with diabetes care [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Associated costs to the family (time away from school and work, travel, etc) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||August 2005|
|Study Completion Date:||November 2009|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
No Intervention: 1
Participants will be seen every 3-4 months with a physician-only visit alternating with a multidisciplinary visit (MD, RN and RD). This is the current standard of practice.
Participants will be seen every 3-4 months with a phone contact, with the diabetes nurse educator, alternating with a multidisciplinary visit (MD, RN and RD).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00521105
|Endocrine Clinic, Alberta Children's Hospital|
|Calgary, Alberta, Canada, T3B 6A8|
|Principal Investigator:||Danièle Pacaud, MD||University of Calgary|