Clinical trial NCT06923046: Implementation of Team Clinic for Type 2 Diabetes (TCT2)
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: American Diabetes Association
First posted: 2025-04-11
Enrollment: 160
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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

Primary outcomes:
measure: Average number of clinics attended over 1 year period to be recorded by Study Coordinator
timeFrame: 1 year
measure: Change in HbA1c for patients from baseline to end of study
timeFrame: 1 year
measure: Clinic Satisfaction
timeFrame: 1 year
Secondary outcomes:
measure: Depression score
timeFrame: 1 year
measure: Mean time-in-range from blinded 14-day continuous glucose monitoring (CGM) for Patients between baseline and 1 year
timeFrame: 1 year
measure: Diabetes distress for patients over 1 year period
timeFrame: 1 year
measure: Change in dietary intake for patients before and after delivery of the dietary intervention
timeFrame: three months
measure: Beliefs about Medicines for patients and parent/caregiver over one year
timeFrame: 1 year
measure: Quality of life for patients
timeFrame: 1 year
Other outcomes:
measure: Patient experience for patient and parent/caregiver
timeFrame: 1 year
measure: Demographic for Patients and Parents/Caregivers
timeFrame: baseline
measure: Sociodemographic History for Parents/Caregivers
timeFrame: baseline
measure: Implementation Outcome Measures for Research Staff
timeFrame: At end of study (end of 1 year)
measure: Parent/Caregiver Clinic Satisfaction Survey
timeFrame: 1 year
measure: Shared Decision Making for Team Clinic Patients and Parents/Caregivers over one year
timeFrame: 1 year
measure: Research Team Appointment Satisfaction Survey
timeFrame: 1 year
measure: Clinician Goals/Plans for Clinicians
timeFrame: 1 year
measure: Healthcare Utilization Form
timeFrame: 1 year
measure: Medication Review
timeFrame: baseline to one year
measure: Adverse Events Form
timeFrame: baseline to one year
measure: Discontinuation and Termination Form
timeFrame: baseline to one year
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: Lily Chao, MD
role: PRINCIPAL_INVESTIGATOR
References: