Assessment of an Alternative Model of Follow-up of Children and Adolescents With Type 1 Diabetes

NCT ID: NCT00521105

Last Updated: 2011-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2009-11-30

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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

2

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).

Group Type: EXPERIMENTAL

Virtual visit

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Diabetes Association

OTHER

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Dr. Danièle Pacaud

Pediatric Endocrinologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Danièle Pacaud, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

Endocrine Clinic, Alberta Children's Hospital

Calgary, Alberta, Canada

Countries

Canada

Other Identifiers

AR-2-05-1823-DP

Identifier Type: -

Identifier Source: org_study_id