Clinical trial NCT06658743: Designing Team Clinic for Youth with Type 2 Diabetes
Official title: Designing Team Clinic for Youth with Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 2 Diabetes
Keywords: youth onset type 2 diabetes
shared medical appointments
group appointments
pediatric type 2 diabetes
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
First posted: 2024-10-26
Enrollment: 74
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: AYA Advisory Council: Participants will include AYAT2D between the ages of 12 to 18.

Caregiver Advisory Group: Participants will include caregivers of AYAT2D.

The Stakeholder Advisory Board will include the PI, co-I's, study coordinator, group facilitators (including Certified Diabetes Care and Education Specialists \[CDCES\], RD, and behavioral health specialist \[BH: psychologist and social worker\]), clinicians, and clinic administrator.

The Curriculum Reviewers will include CDCESs, nurses, nurse practitioners, dieticians, social workers or physicians in the diabetes clinic.

Brief summary: The goal of this clinical trial is to learn about 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:

* Design four group activities centered around nutrition therapy, peer interactions, exercise and stress management.
* Design the clinical workflow for implementation phase.

Participants will attend quarterly clinic appointments and group activities and take surveys. Researchers will compare this intervention to standard of care.


Eligibility criteria: AYA Advisory Council Inclusion Criteria

* Age 12 to 18 at time of study enrollment
* Receives care for type 2 diabetes
* Willingness to attend all meetings
* English-speaking

Exclusion Criteria • Non-verbal or unable to participate in group activities and discussions

Caregiver Advisory Council Inclusion Criteria

* Age 18 or above
* Caregiver of AYA with type 2 diabetes
* Willingness to attend all meetings
* English- or Spanish-speaking

Exclusion Criteria

* Non-verbal or unable to participate in group activities and discussions

Stakeholder Advisory Board Inclusion Criteria

* Age 18 or above
* On staff at CHLA or UCSF
* Clinical or administrative member of the diabetes clinic
* Willingness to participate in monthly meetings. If unable to attend, willingness to review meeting minutes.

Exclusion Criteria • None

Curriculum Reviewers Inclusion Criteria

* Age 18 or above
* CDCESs, nurses, nurse practitioners, dieticians, social workers or physicians in the diabetes clinic
* Clinical members of the diabetes clinic

Exclusion Criteria

• Member of the Stakeholder Advisory Board

Primary outcomes:
measure: Design four group activities for Team Clinic for youth with type 2 diabetes
timeFrame: Baseline to 5 months
measure: Design Team Clinic for youth with type 2 diabetes workflow
timeFrame: Baseline to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: San Francisco
country: United States
facility: UCSF
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: Lily Chao, MD
role: PRINCIPAL_INVESTIGATOR
References: