Implementation of Team Clinic for Type 2 Diabetes (TCT2)

Children's Hospital Los Angeles

Status: Enrolling

Conditions: Type 2 Diabetes

Treatments: Other: Standard of Care; Behavioral: Shared Medical Appointments

Study type: Interventional

Funder types: Other

Identifiers

NCT06923046

CHLA-25-00070

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups, including a placebo group

Standard Care

Placebo Comparator group

Description:

Multidisciplinary team based care every 3 months.

Treatment:

Other: Standard of Care

Shared Medical Appointment

Active Comparator group

Description:

Participants will attend 4 quarterly appointments. In addition to time with their clinician, they will also have group activities that address relevant topics.

Treatment:

Behavioral: Shared Medical Appointments