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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
160
Multidisciplinary team based care every 3 months.
Participants will attend 4 quarterly appointments. In additionto time with their clinician, they will also have groupactivities that address relevant topics.
Children's Hospital Los Angeles
Los Angeles, California, United States
RECRUITINGUniversity of California, San Francisco
San Francisco, California, United States
NOT_YET_RECRUITINGAverage number of clinics attended over 1 year period to be recorded by Study Coordinator
Data collected is the number of patient visits to the clinic.
Time frame: 1 year
Change in HbA1c for patients from baseline to end of study
Patients' glycemic outcomes will be taken every session (Visit 0 (baseline) - Visit 4) over a one-year period
Time frame: 1 year
Clinic Satisfaction
Patient participants will complete satisfaction survey at the end of each visit using a 5-point Likert scale; "Strongly disagree" is 1, "disagree" is 2, "neutral" is 3, "agree" is 4, "strongly agree" is 5.
Time frame: 1 year
Depression score
The patient health questionnaire-8 is a measure of depression severity that will be administered at baseline and again at the end of the study.
Time frame: 1 year
Mean time-in-range from blinded 14-day continuous glucose monitoring (CGM) for Patients between baseline and 1 year
A blinded CGM device will be applied to patients at enrollment and at the final study visit to capture glycemic control
Time frame: 1 year
Diabetes distress for patients over 1 year period
The Diabetes Distress Scale 2 is a 2 question prescreen that will be used to prescreen emotional burden. A score of 3 or higher on the DDS-2 will lead to the use of the 17-item survey.
Time frame: 1 year
Change in dietary intake for patients before and after delivery of the dietary intervention
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The Dietary Screen Questionnaire (DSQ) will be administered to track changes in food habits before and after delivery of the intervention (session 2).
Time frame: three months
Beliefs about Medicines for patients and parent/caregiver over one year
Beliefs about Medicines Questionnaire (BMQ) is used to any change in patients beliefs and concerns about medications. It has been validated as a proxy for medication adherence.
Time frame: 1 year
Quality of life for patients
The Pediatric Quality of Life Inventory 3.2 (PedsQL 3.2) will be administered to assess changes in diabetes symptoms and management.
Time frame: 1 year