Standard of care
OtherMultidisciplinary team based care every 3 months.
NCT Number: NCT06923046
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.
Interested in participating?
Request Info12 year–18 year
All sexes
Interventional
Not applicable
Children's Hospital Los Angeles, Los Angeles, California, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Patient/AYA Participants
Inclusion criteria
Exclusion criteria
Caregiver/Parents Participants
Inclusion criteria
Exclusion criteria
-Inability or unwillingness of individual to give written informed consent
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.
Time frame: 1 year
Data collected is the number of patient visits to the clinic.
Time frame: 1 year
Patients' glycemic outcomes will be taken every session (Visit 0 (baseline) - Visit 4) over a one-year period
Time frame: 1 year
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
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
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
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: three months
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: 1 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
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
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: baseline
Self-reported demographic history (date of birth, gender, race and/or ethnicity, education, etc) will be collected.
Time frame: baseline
Self-reported sociodemographic history (work status, marital members, household income, etc)
Time frame: At end of study (end of 1 year)
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: 1 year
Survey will assess clinic satisfaction experience after each visit though a likert scale. Likert scale; "Strongly disagree" is 1, "disagree" is 2, "neutral" is 3, "agree" is 4, "strongly agree" is 5.
Time frame: 1 year
Shared decision making tool assess AYA and parent/caregiver's priorities for each medical visit using a mix of multiple choice and open-ended questions.
Time frame: 1 year
Survey will assess clinic satisfaction experience after each visit though a likert scale. Likert scale; "Strongly disagree" is 1, "disagree" is 2, "neutral" is 3, "agree" is 4, "strongly agree" is 5. Also, includes 4 open-ended questions to measures satisfaction for shared medical appointments.
Time frame: 1 year
Clinicians will work with families to discuss goals and plans guided by responding to 5 open-ended questions at each visit. Each member (Clinician, family, and AYA) will respond to these questions.
Time frame: 1 year
Healthcare Utilization Form is a 3-item survey that assess 911 call or emergency room usage for diabetic ketoacidosis, or severe hypoglycemia requiring glucagon.
Time frame: baseline to one year
General health history through review of participants EMR, completed by study coordinator
Time frame: baseline to one year
The adverse events form will track any ED visits related to diabetes, DKA admissions, etc. throughout the study. It will be completed by Study Coordinator
Time frame: baseline to one year
The discontinuation and termination form tracks reason for discontinuation of patient and agreement of continuation of medical records. To be completed by research coordinator.
Contact information is provided by the study sponsor or research team.
Fatima Aguilar
CONTACT
Lily Chao, MD
CONTACT
Children's Hospital Los Angeles
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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