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

NCT02547311 | Completed

• 2 other identifiers: 12-1281#2015PG-T1D080
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (4)

• Glycemic control

  Hemoglobin A1c

  30 months

• Satisfaction Questionnaire

  Clinic satisfaction (patient and parent)

  30 months

• Diabetes distress Questionnaire

  Diabetes distress (patient and parent)

  30 months

• Cost effectiveness

  Clinical cost effectiveness of intervention

  30 months

Study Arms (2)

Team Clinic Intervention

EXPERIMENTAL

Middle School and High School Team Clinic Intervention

Behavioral: Team Clinic

Standard Clinical Care - Control

NO INTERVENTION

Standard Clinical Care - Control

Interventions

Team Clinic BEHAVIORAL

Team Clinic Intervention

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• The Leona M. and Harry B. Helmsley Charitable Trust: collaborator

Study Sites (1)

University of Colorado Denver School of Medicine Barbara Davis Center

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jennifer Raymond, MD, MCR

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2015
• First Posted: September 11, 2015
• Study Start: October 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: January 18, 2022

Record last verified: 2022-01

Locations

US (1)