[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587027":3},{"organization":4,"outcomesModule":7,"designInfo":79,"detailedDescription":82,"studyPopulation":82,"armGroups":86,"interventions":99,"overallOfficials":108,"centralContacts":112,"locations":120,"responsibleParty":147,"collaborators":150,"id":154,"slug":82,"hasResults":155,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":82,"eligibilityCriteria":159,"healthyVolunteers":155,"sex":160,"minAge":161,"maxAge":162,"enrollmentInfo":163,"targetDuration":82,"studyType":166,"phases":167,"briefSummary":169,"conditions":170,"keywords":82,"overallStatus":122,"whyStopped":82,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":181},{"fullName":5,"class":6},"Children's Hospital Los Angeles","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":39},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"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.","1 year",{"measure":14,"description":15,"timeFrame":12},"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",{"measure":17,"description":18,"timeFrame":12},"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.",[20,23,26,29,33,36],{"measure":21,"description":22,"timeFrame":12},"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.",{"measure":24,"description":25,"timeFrame":12},"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",{"measure":27,"description":28,"timeFrame":12},"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.",{"measure":30,"description":31,"timeFrame":32},"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).","three months",{"measure":34,"description":35,"timeFrame":12},"Beliefs about Medicines for patients and parent\u002Fcaregiver 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.",{"measure":37,"description":38,"timeFrame":12},"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.",[40,43,47,50,54,57,60,63,66,69,73,76],{"measure":41,"description":42,"timeFrame":12},"Patient experience for patient and parent\u002Fcaregiver","The Consumer Assessment of Healthcare Providers \\& Systems survey (CAHPS)assesses patient-clinician communication, experiences of discrimination based on race\u002Fethnicity, 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.",{"measure":44,"description":45,"timeFrame":46},"Demographic for Patients and Parents\u002FCaregivers","Self-reported demographic history (date of birth, gender, race and\u002For ethnicity, education, etc) will be collected.","baseline",{"measure":48,"description":49,"timeFrame":46},"Sociodemographic History for Parents\u002FCaregivers","Self-reported sociodemographic history (work status, marital members, household income, etc)",{"measure":51,"description":52,"timeFrame":53},"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.","At end of study (end of 1 year)",{"measure":55,"description":56,"timeFrame":12},"Parent\u002FCaregiver Clinic Satisfaction Survey","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.",{"measure":58,"description":59,"timeFrame":12},"Shared Decision Making for Team Clinic Patients and Parents\u002FCaregivers over one year","Shared decision making tool assess AYA and parent\u002Fcaregiver's priorities for each medical visit using a mix of multiple choice and open-ended questions.",{"measure":61,"description":62,"timeFrame":12},"Research Team Appointment Satisfaction Survey","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.",{"measure":64,"description":65,"timeFrame":12},"Clinician Goals\u002FPlans for Clinicians","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.",{"measure":67,"description":68,"timeFrame":12},"Healthcare Utilization Form","Healthcare Utilization Form is a 3-item survey that assess 911 call or emergency room usage for diabetic ketoacidosis, or severe hypoglycemia requiring glucagon.",{"measure":70,"description":71,"timeFrame":72},"Medication Review","General health history through review of participants EMR, completed by study coordinator","baseline to one year",{"measure":74,"description":75,"timeFrame":72},"Adverse Events Form","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",{"measure":77,"description":78,"timeFrame":72},"Discontinuation and Termination Form","The discontinuation and termination form tracks reason for discontinuation of patient and agreement of continuation of medical records. To be completed by research coordinator.",{"allocation":80,"interventionModel":81,"interventionModelDescription":82,"primaryPurpose":83,"observationalModel":82,"timePerspective":82,"maskingInfo":84},"RANDOMIZED","PARALLEL",null,"HEALTH_SERVICES_RESEARCH",{"masking":85,"maskingDescription":82,"whoMasked":82},"NONE",[87,93],{"label":88,"type":89,"description":90,"interventionNames":91},"Standard Care","PLACEBO_COMPARATOR","Multidisciplinary team based care every 3 months.",[92],"Other: Standard of Care",{"label":94,"type":95,"description":96,"interventionNames":97},"Shared Medical Appointment","ACTIVE_COMPARATOR","Participants will attend 4 quarterly appointments. In addition to time with their clinician, they will also have group activities that address relevant topics.",[98],"Behavioral: Shared Medical Appointments",[100,103],{"type":6,"name":101,"description":90,"armGroupLabels":102,"otherNames":82},"Standard of Care",[88],{"type":104,"name":105,"description":106,"armGroupLabels":107,"otherNames":82},"BEHAVIORAL","Shared Medical Appointments","Participants will attend 4 quarterly appointments. In additionto time with their clinician, they will also have groupactivities that address relevant topics.",[94],[109],{"name":110,"affiliation":5,"role":111},"Lily Chao, MD","PRINCIPAL_INVESTIGATOR",[113,118],{"name":114,"role":115,"phone":116,"phoneExt":82,"email":117},"Fatima Aguilar","CONTACT","323-361-4606","faguilar@chla.usc.edu",{"name":110,"role":115,"phone":116,"phoneExt":82,"email":119},"chao@chla.usc.edu",[121,137],{"facility":5,"status":122,"city":123,"state":124,"zip":125,"country":126,"countryCode":127,"cosmosGeoPoint":128,"geoPoint":133,"contacts":134},"RECRUITING","Los Angeles","California","91316","United States","US",{"type":129,"coordinates":130},"Point",[131,132],-118.24368,34.05223,{"lat":132,"lon":131},[135],{"name":136,"role":111,"phone":82,"phoneExt":82,"email":82},"Lily Chao, MD, MS",{"facility":138,"status":139,"city":140,"state":124,"zip":141,"country":126,"countryCode":127,"cosmosGeoPoint":142,"geoPoint":146,"contacts":82},"University of California, San Francisco","NOT_YET_RECRUITING","San Francisco","94143-0434",{"type":129,"coordinates":143},[144,145],-122.41942,37.77493,{"lat":145,"lon":144},{"type":111,"investigatorFullName":148,"investigatorTitle":149,"investigatorAffiliation":5,"oldNameTitle":82,"oldOrganization":82},"lily chao","Principal Investigator",[151,152],{"name":138,"class":6},{"name":153,"class":6},"American Diabetes Association","100587027",false,"NCT06923046","Implementation of Team Clinic for Type 2 Diabetes (TCT2)","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","Patient\u002FAYA Participants\n\nInclusion Criteria:\n\n* Receives care for type 2 diabetes at either CHLA or UCSF\n* English speaking youth\n* Youth prescribed medication for type 2 diabetes\n* English or Spanish speaking caregivers\n* Age 12 to 18 years old at the time of enrollment\n* Willingness to attend clinic visits and participate in group session (if randomized to Team Clinic), complete surveys\n\nExclusion Criteria:\n\n* Participants who are non-verbal or unable to participate in group activities and discussions\n* Pregnancy\n* Inability or unwillingness of individual or legal guardian\u002Frepresentative to give written informed assent\u002Fconsent\n\nCaregiver\u002FParents Participants\n\nInclusion Criteria:\n\n* 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\u002Fassent to participate as a youth participant.\n* 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\n* Willingness to participate in group session (if their child is randomized to Team Clinic) and complete surveys.\n\nExclusion Criteria:\n\n-Inability or unwillingness of individual to give written informed consent","ALL","12 Years","18 Years",{"count":164,"type":165},160,"ESTIMATED","INTERVENTIONAL",[168],"NA","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.\n\nThe main question\\[s\\] it aims to answer are:\n\n* Is shared medical appointments an acceptable care delivery model for this population?\n* Does shared medical appointment improve psychosocial outcomes for this population?\n\nParticipants will attend quarterly clinic appointments and group activities and take surveys. Researchers will compare this intervention to standard of care.",[171],"Type 2 Diabetes","2025-10-27",{"date":174,"type":175},"2025-10-29","ACTUAL",{"date":177,"type":175},"2025-08-14",{"date":179,"type":165},"2027-06-30",{"name":5,"class":6},2]