Implementation of Team Clinic for Type 2 Diabetes (TCT2)
ConditionType 2 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorChildren's Hospital Los Angeles
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Standard of Care
Other interventionMultidisciplinary team based care every 3 months.
Shared Medical Appointments
BehavioralParticipants will attend 4 quarterly appointments. In additionto time with their clinician, they will also have groupactivities that address relevant topics.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Standard CarePlacebo comparator 1 intervention
Group B: Shared Medical AppointmentActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Average 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 year2
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 year3
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 yearSecondary outcomes
1
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 year2
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 year3
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 year4
Change in dietary intake for patients before and after delivery of the dietary intervention
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 monthsOther outcomes
1
Patient experience for patient and parent/caregiver
The Consumer Assessment of Healthcare Providers \& Systems survey (CAHPS)assesses patient-clinician communication, experiences of discrimination based on race/ethnicity, insurance, and experiences leading to trust or distrust. Patient experience will be compared between control and intervention groups, both at baseline and at one year.
Time frame
1 year2
Demographic for Patients and Parents/Caregivers
Self-reported demographic history (date of birth, gender, race and/or ethnicity, education, etc) will be collected.
Time frame
baseline3
Sociodemographic History for Parents/Caregivers
Self-reported sociodemographic history (work status, marital members, household income, etc)
Time frame
baseline4
Implementation Outcome Measures for Research Staff
Implementation Outcome measure is used in behavioral health care as a psycho metric quality and will be used to assess how effectively clinic is being implemented.
Time frame
At end of study (end of 1 year)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital Los Angeles
Lead sponsor
University of California, San Francisco
Collaborator
American Diabetes Association
Collaborator
Source ClinicalTrials.gov