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

Sponsor

University of Colorado, Denver (Other)

Overall Status

Completed

CT.gov ID

NCT02547311

Collaborator

The Leona M. and Harry B. Helmsley Charitable Trust (Other)

318

Enrollment

Location

Arms

Actual Duration (Months)

9.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes	Behavioral: Team Clinic	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

318 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Actual Study Start Date :

Oct 1, 2012

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Team Clinic Intervention Middle School and High School Team Clinic Intervention	Behavioral: Team Clinic
No Intervention: Standard Clinical Care - Control Standard Clinical Care - Control

Arm

Intervention/Treatment

Experimental: Team Clinic Intervention

Middle School and High School Team Clinic Intervention

Behavioral: Team Clinic

No Intervention: Standard Clinical Care - Control

Standard Clinical Care - Control

Outcome Measures

Primary Outcome Measures

Glycemic control [30 months]
Hemoglobin A1c
Satisfaction Questionnaire [30 months]
Clinic satisfaction (patient and parent)
Diabetes distress Questionnaire [30 months]
Diabetes distress (patient and parent)
Cost effectiveness [30 months]
Clinical cost effectiveness of intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:

11 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

T1D >1 year duration, 6th-10th grade

Exclusion Criteria:

non-English speaking
severe behavioral, developmental, or psychological diagnosis making group participation difficult

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Denver School of Medicine Barbara Davis Center	Aurora	Colorado	United States	80045

Sponsors and Collaborators

University of Colorado, Denver
The Leona M. and Harry B. Helmsley Charitable Trust

Investigators

Principal Investigator: Jennifer Raymond, MD, MCR, University of Colorado, Denver

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT02547311

Other Study ID Numbers:

12-1281
#2015PG-T1D080

First Posted:

Sep 11, 2015

Last Update Posted:

Jan 18, 2022

Last Verified:

Jan 1, 2022

Additional relevant MeSH terms:

Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Jan 18, 2022