Assessment of an Alternative Model of Follow-up of Children and Adolescents With Type 1 Diabetes
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Virtual visit
Sponsored by
About this trial
This is an interventional health services research trial for Type 1 Diabetes Mellitus focused on measuring Type 1 Diabetes, Telemedicine, Children
Eligibility Criteria
Inclusion Criteria:
- Children: 17 years of age or less
- Diagnosis of Type 1 Diabetes for at least 12 months
- Currently being followed at the Alberta Children's Hospital Diabetes Clinic.
Exclusion Criteria:
- Compromised metabolic control (HbA1c > 10%)
- Uncontrolled hypo or hyperthyroidism
- Uncontrolled celiac disease
- Language or psychosocial barrier preventing the family from completing the study
- Diabetes duration of less than 1 year
- Participation in other clinical trials with specified clinic visits.
Sites / Locations
- Endocrine Clinic, Alberta Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
1
2
Arm Description
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).
Outcomes
Primary Outcome Measures
Medical outcomes: HbA1c, rates of severe hypoglycemia, rates of DKA
Secondary Outcome Measures
Resource utilization: physicians, nurses, and dietitians, emergency room visits
Family satisfaction with diabetes care
Associated costs to the family (time away from school and work, travel, etc)
Full Information
NCT ID
NCT00521105
First Posted
August 24, 2007
Last Updated
October 5, 2011
Sponsor
University of Calgary
Collaborators
Canadian Diabetes Association
1. Study Identification
Unique Protocol Identification Number
NCT00521105
Brief Title
Assessment of an Alternative Model of Follow-up of Children and Adolescents With Type 1 Diabetes
Official Title
Assessment of an Alternative Model Using Telemedicine Follow-up of Children and Adolescents With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
Canadian Diabetes Association
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Type 1 Diabetes, Telemedicine, Children
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Description
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.
Arm Title
2
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Virtual visit
Intervention Description
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.
Primary Outcome Measure Information:
Title
Medical outcomes: HbA1c, rates of severe hypoglycemia, rates of DKA
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Resource utilization: physicians, nurses, and dietitians, emergency room visits
Time Frame
1 year
Title
Family satisfaction with diabetes care
Time Frame
1 year
Title
Associated costs to the family (time away from school and work, travel, etc)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children: 17 years of age or less
Diagnosis of Type 1 Diabetes for at least 12 months
Currently being followed at the Alberta Children's Hospital Diabetes Clinic.
Exclusion Criteria:
Compromised metabolic control (HbA1c > 10%)
Uncontrolled hypo or hyperthyroidism
Uncontrolled celiac disease
Language or psychosocial barrier preventing the family from completing the study
Diabetes duration of less than 1 year
Participation in other clinical trials with specified clinic visits.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danièle Pacaud, MD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Endocrine Clinic, Alberta Children's Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Assessment of an Alternative Model of Follow-up of Children and Adolescents With Type 1 Diabetes
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