Shared Medical Appointments to Improve Outcomes in Adolescents With Type 1 Diabetes

Sponsors

Lead Sponsor: University of Colorado Denver School of Medicine Barbara Davis Center

Collaborator: The Leona M. and Harry B. Helmsley Charitable Trust

Source University of Colorado Denver School of Medicine Barbara Davis Center
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.

Overall Status Unknown status
Start Date July 2015
Completion Date April 2018
Primary Completion Date April 2018
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Glycemic control 30 months
Satisfaction Questionnaire 30 months
Diabetes distress Questionnaire 30 months
Cost effectiveness 30 months
Enrollment 320
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Team Clinic

Arm Group Label: Team Clinic Intervention

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

Gender: All

Minimum Age: 11 Years

Maximum Age: 17 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Jennifer Raymond, MD, MCR Principal Investigator University of Colorado, Denver
Overall Contact

Last Name: Jennifer Raymond, MD, MCR

Phone: 3037246769

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: University of Colorado Denver School of Medicine Barbara Davis Center Jackie Shea 303-724-7861 [email protected]
Location Countries

United States

Verification Date

September 2015

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Colorado Denver School of Medicine Barbara Davis Center

Investigator Full Name: Jennifer Raymond

Investigator Title: MD, MCR, Assistant Professor, Pediatric Endocrinology

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Team Clinic Intervention

Type: Experimental

Description: Middle School and High School Team Clinic Intervention

Label: Standard Clinical Care - Control

Type: No Intervention

Description: Standard Clinical Care - Control

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Health Services Research

Masking: None (Open Label)

Source: ClinicalTrials.gov