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Implementation of Team Clinic for Type 2 Diabetes (TCT2)

NCT06923046 · Children's Hospital Los Angeles
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
Implementation of Team Clinic for Type 2 Diabetes (TCT2): A Randomized Standard Care-controlled Two-site 80-subject Clinical Trial of Shared Medical Appointment Model for Adolescents With Type 2 Diabetes
About this study
The goal of this clinical trial is to learn if shared medical appointment is an acceptable way to deliver care to youth with type 2 diabetes. The main question\[s\] it aims to answer are: * Is shared medical appointments an acceptable care delivery model for this population? * Does shared medical appointment improve psychosocial outcomes for this population? Participants will attend quarterly clinic appointments and group activities and take surveys. Researchers will compare this intervention to standard of care.
Eligibility criteria
Patient/AYA Participants Inclusion Criteria: * Receives care for type 2 diabetes at either CHLA or UCSF * English speaking youth * Youth prescribed medication for type 2 diabetes * English or Spanish speaking caregivers * Age 12 to 18 years old at the time of enrollment * Willingness to attend clinic visits and participate in group session (if randomized to Team Clinic), complete surveys Exclusion Criteria: * Participants who are non-verbal or unable to participate in group activities and discussions * Pregnancy * Inability or unwillingness of individual or legal guardian/representative to give written informed assent/consent Caregiver/Parents Participants Inclusion Criteria: * Has a child between the ages of 12 and up to 18 at the time of enrollment who receives care for T2D in the endocrinology clinic at CHLA. The child must provide consent/assent to participate as a youth participant. * Speaks English of Spanish. Over 95% of our T2D population speaks one of those two languages. Our facilitator will be bilingual in English and Spanish. It is not feasible for the facilitator to also speak another language. Having a language interpreter for discussion groups will affect the dynamics and flow of the group session * Willingness to participate in group session (if their child is randomized to Team Clinic) and complete surveys. Exclusion Criteria: -Inability or unwillingness of individual to give written informed consent
Study design
Enrollment target: 160 participants
Allocation: randomized
Masking: none
Age groups: child, adult
Timeline
Starts: 2025-08-14
Estimated completion: 2027-06-30
Last updated: 2025-10-29
Interventions
Other: Standard of CareBehavioral: Shared Medical Appointments
Primary outcomes
  • Average number of clinics attended over 1 year period to be recorded by Study Coordinator (1 year)
  • Change in HbA1c for patients from baseline to end of study (1 year)
  • Clinic Satisfaction (1 year)
Sponsor
Children's Hospital Los Angeles · other
With: University of California, San Francisco, American Diabetes Association
Contacts & investigators
ContactFatima Aguilar · contact · faguilar@chla.usc.edu · 323-361-4606
ContactLily Chao, MD · contact · chao@chla.usc.edu · 323-361-4606
InvestigatorLily Chao, MD · principal_investigator, Children's Hospital Los Angeles
All locations (2)
Children's Hospital Los AngelesRecruiting
Los Angeles, California, United States
University of California, San FranciscoNot Yet Recruiting
San Francisco, California, United States
Implementation of Team Clinic for Type 2 Diabetes (TCT2) · TrialPath