Shared Medical Appointments to Improve Outcomes in Adolescents With Type 1 Diabetes
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Team Clinic
Sponsored by
About this trial
This is an interventional health services research trial for Type 1 Diabetes
Eligibility Criteria
Inclusion Criteria:
- T1D >1 year duration, 6th-10th grade
Exclusion Criteria:
- non-English speaking
- severe behavioral, developmental, or psychological diagnosis making group participation difficult
Sites / Locations
- University of Colorado Denver School of Medicine Barbara Davis Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Team Clinic Intervention
Standard Clinical Care - Control
Arm Description
Middle School and High School Team Clinic Intervention
Standard Clinical Care - Control
Outcomes
Primary Outcome Measures
Glycemic control
Hemoglobin A1c
Satisfaction Questionnaire
Clinic satisfaction (patient and parent)
Diabetes distress Questionnaire
Diabetes distress (patient and parent)
Cost effectiveness
Clinical cost effectiveness of intervention
Secondary Outcome Measures
Full Information
NCT ID
NCT02547311
First Posted
September 9, 2015
Last Updated
January 3, 2022
Sponsor
University of Colorado, Denver
Collaborators
The Leona M. and Harry B. Helmsley Charitable Trust
1. Study Identification
Unique Protocol Identification Number
NCT02547311
Brief Title
Shared Medical Appointments to Improve Outcomes in Adolescents With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
October 2012 (Actual)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
The Leona M. and Harry B. Helmsley Charitable Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Adolescents and emerging adults with type 1 diabetes (T1D) experience significant struggles with their diabetes management resulting in worsening diabetes health and increased complications. This population's declining well-being occurs during a time when they should be at their healthiest and enjoying multiple exciting life transitions. Their worsening diabetes management is complicated by the fact they are also learning how to become more independent from their family in preparation for eventually leaving home. Furthermore, the number of people under 20 years of age diagnosed with T1D has increased dramatically over the past 10 years giving rise to increased concern about providing care to this population.
The Team Clinic Intervention is an innovative clinical care approach to address the medical and developmental needs of adolescents with T1D and their families. A group medical appointment format will be used for routine diabetes clinic visits in middle school and high school adolescents with T1D. Parents of these patients will be participating in their own group during these clinic visits. The Team Clinic model incorporates developmentally tailored peer support and novel learning tools, (e.g. games, physical activity, and/or interaction through Internet resources, e.g. blogs, forums) into the shared medical appointment design.
The goal of Team Clinic Intervention is to improve medical and psychological outcomes in adolescents with T1D and their parents. The study will investigate, in a randomized controlled trial, the efficacy of a novel clinical care model that addresses the unique developmental strengths and weaknesses of the T1D adolescent population. The Team Clinic format streamlines clinical care delivery to this often-challenging patient population without placing additional burden on youth, families, or clinics because the intervention will be completed during routine diabetes care visits. Moreover, the Team Clinic approach maximizes the benefits of peer support by delivering care in a group format to address the sense of isolation that teens and families coping with chronic illness often feel.
If successful, the Team Clinic Intervention will not only positively impact adolescents with T1D and their families, but it could be used as a model of care for other adolescents with chronic medical conditions struggling to remain involved and invested in their medical care. Team Clinics may be one approach to successfully engaging adolescents in their diabetes care prior to their transition away from home, which will help them remain invested and active in their medical care through adolescence and young adulthood.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
318 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Team Clinic Intervention
Arm Type
Experimental
Arm Description
Middle School and High School Team Clinic Intervention
Arm Title
Standard Clinical Care - Control
Arm Type
No Intervention
Arm Description
Standard Clinical Care - Control
Intervention Type
Behavioral
Intervention Name(s)
Team Clinic
Primary Outcome Measure Information:
Title
Glycemic control
Description
Hemoglobin A1c
Time Frame
30 months
Title
Satisfaction Questionnaire
Description
Clinic satisfaction (patient and parent)
Time Frame
30 months
Title
Diabetes distress Questionnaire
Description
Diabetes distress (patient and parent)
Time Frame
30 months
Title
Cost effectiveness
Description
Clinical cost effectiveness of intervention
Time Frame
30 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
T1D >1 year duration, 6th-10th grade
Exclusion Criteria:
non-English speaking
severe behavioral, developmental, or psychological diagnosis making group participation difficult
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Raymond, MD, MCR
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver School of Medicine Barbara Davis Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Shared Medical Appointments to Improve Outcomes in Adolescents With Type 1 Diabetes
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