[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07706803":3,"trial-entities:NCT07706803":85,"trial-summary:NCT07706803":89},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":36,"secondary_outcomes":45,"sex":50,"minimum_age":16,"maximum_age":51,"healthy_volunteers":52,"eligibility_criteria":53,"std_ages":59,"locations":62,"central_contacts":77,"overall_officials":79,"references":83,"see_also_links":84},"NCT07706803","IRB#25-0333","Screening For Social Determinants Of Health In Routine Diabetes Care","NOT_YET_RECRUITING","2028-09","2026-07","2026-07-16","2026-09","University of California, Los Angeles","OTHER",true,"Social determinants of health (SDOH) exert a powerful influence on the everyday management of type 1 diabetes (T1D) and short and long term outcomes of T1D. Experts agree that identifying and addressing negative social determinants of health (SDOH) may help accomplish numerous T1D care goals and promote health equity in treatment. However, fundamental research gaps in achieving these goals remain, including optimal screening and management processes for identification of negative social determinants of health (SDOH) , and how to develop robust partnerships with community-based organizations (CBOs) that address social determinants of health (SDOH) with high potential for sustainability and scalability. This project will generate new knowledge regarding how to implement a social work-led social determinants of health (SDOH) screening and referral program designed to aid families of youth with T1D who face several vulnerabilities, including food insecurity. The team will implement a single arm, pragmatic clinical trial with contemporaneous, non- randomized controls; whereby all families with a child enrolled in the California Children's Services (CCS) program (which provides specialized medical care for low-income families of youth with a qualifying chronic medical condition) will receive access to a novel social work-led social determinants of health (SDOH) screening and referral program.\n\nOutcomes will be compared against youth with T1D who are also seen in our Westwood Pediatric Endocrinology clinic but who are not enrolled in the CCS program and will not receive access to the social determinants of health (SDOH) intervention. The study team has established partnerships with several community-based organizations (CBOs) across Los Angeles County that provide social services, including food-related services, to receive referrals for CCS families who screen positive for having a social need. The study team will assess the feasibility and acceptability of this screening and referral protocol among families, CBOs, and providers (Aim 1) by measuring key implementation outcomes (comprehensive documentation of social determinants of health (SDOH) screening, result, and referral in the patients' medical record) and acceptability outcomes (self-reported satisfaction with the program by families and barriers and facilitators by CBOs and providers). The team will additionally estimate the effect of this intervention (Aim 2) by measuring changes (pre\u002Fpost intervention) in families reported social needs, diabetes-related quality of life, and in the child's glycemic control (measured by HbA1c). Results from this work can provide a roadmap for sustainable and scalable social determinants of health (SDOH) interventions with potential to improve outcomes for youth with T1D in an equity-informed manner.",null,[18],"Type 1 Diabetes",[20,21],"Type 1 diabetes","Pediatric","INTERVENTIONAL","PREVENTION",[25],"NA",{"count":27,"type":28},150,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"BEHAVIORAL","Social Determinants of Health (SDOH) Screening and Referral","This study is proposing a social work-led SDOH screening and intervention program. Social workers will screen patients\u002Ffamilies for SDOH and respond based on the results of the screen. Patients\u002Ffamilies identified as \"low risk\" (i.e., do not screen positive on the SDOH screener) will receive information about 1degree.org and phone follow-up two weeks after visit to see if there are any questions about the platform or any changes to their social circumstances that they wish to discuss with the social work team. Patients\u002Ffamilies identified as \"high risk\" (i.e., screen positive on the SDOH screener) will receive the 1degree.org information sheet as well as receive specific agency referrals to our partner food bank organizations and two week phone follow-up to assess referral success; these patients\u002Ffamilies will subsequently receive follow-up calls every two weeks until the referral is complete or the patient\u002Ffamily discloses that their identified food insecurity is resolved.",[35],"SDOH Screening and Intervention Program",[37,41],{"measure":38,"description":39,"timeFrame":40},"Documentation of SDOH screening","The primary feasibility outcomes include documentation of SDOH screening (performed vs not), result (positive vs negative), and referrals (made vs not, completed vs not) in the medical record. The study will quantify the prevalence of each of these individually, as well as collectively to identify the extent to which documentation was comprehensive (i.e., screening and result, plus referral when appropriate, all documented).","Baseline visit, final follow-up (6 months post-baseline)",{"measure":42,"description":43,"timeFrame":44},"Family-reported satisfaction with screening (acceptability)","A 3-item measure of patient satisfaction with care, rated on a 10-point Likert scale, will be assessed in an immediate post-visit survey, and the in-depth Consumer Assessment of Healthcare Providers and Systems (CAHPS) will be used in the pre\u002Fpost surveys.","All three survey time points (pre, immediate post, 6-month post)",[46],{"measure":47,"description":48,"timeFrame":49},"Change in Hemoglobin A1c","For our secondary clinical outcome of change in HbA1c, a continuous variable, we will compare the change in HbA1c, as documented in the clinical record, from baseline to that of 6 months post-intervention.","baseline and 6 months follow-up","ALL","21 Years",false,{"inclusion":54,"exclusion":56,"raw_text":58},[55],"1\\) patients who are 0-21 years old, diagnosed with T1D, and receive T1D care from the UCLA Pediatric Diabetes program at the Westwood clinic, and\u002For 2) parents\u002Flegal guardians of a child with T1D and whose child is 21 years old or under and receives T1D care from the UCLA Pediatric Diabetes program at the Westwood clinic.",[57],"1\\) patients who are over 21 years old and diagnosed with Type 2 Diabetes or prediabetes, and 2) parents\u002Flegal guardians of a child with type 2 diabetes or prediabetes and whose child is over 21 years old.","Inclusion Criteria:\n\n* 1\\) patients who are 0-21 years old, diagnosed with T1D, and receive T1D care from the UCLA Pediatric Diabetes program at the Westwood clinic, and\u002For 2) parents\u002Flegal guardians of a child with T1D and whose child is 21 years old or under and receives T1D care from the UCLA Pediatric Diabetes program at the Westwood clinic.\n\nExclusion Criteria:\n\n* 1\\) patients who are over 21 years old and diagnosed with Type 2 Diabetes or prediabetes, and 2) parents\u002Flegal guardians of a child with type 2 diabetes or prediabetes and whose child is over 21 years old.",[60,61],"CHILD","ADULT",[63],{"facility":12,"city":64,"state":65,"zip":66,"country":67,"contacts":68,"geoPoint":74},"Los Angeles","California","90095","United States",[69],{"name":70,"role":71,"phone":72,"email":73},"Lauren Wisk, PhD","CONTACT","310-267-5308","lwisk@mednet.ucla.edu",{"lat":75,"lon":76},34.05223,-118.24368,[78],{"name":70,"role":71,"phone":72,"email":73},[80],{"name":70,"affiliation":81,"role":82},"Lauren Wisk","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":86,"biomarkers":88},[87],"Type 1 Diabetes Mellitus",[],{"nct_id":4,"found":14,"summary":90,"prompt_version":100},{"design":91,"status":92,"heading":93,"summary":94,"follow_up":95,"word_count":96,"commitments":97,"compensation":98,"drugs_mentioned":99},"This is an interventional study, meaning it tests a specific approach. It plans to include 150 participants.","completed","Screening for Social Determinants of Health in Type 1 Diabetes Care","This study is looking at how to best screen for and address social determinants of health (SDOH) in children and young adults with Type 1 Diabetes (T1D). SDOH are factors like your living situation, access to healthy food, or financial stability that can affect your health. The study will test a program where social workers screen patients and families for SDOH and then provide support based on the results. We want to see if this screening is documented well and if families are satisfied with the process. You may be able to join if you are 21 years old or younger with T1D, or a parent\u002Fguardian of such a child, and receive care at the UCLA Pediatric Diabetes program in Westwood. The study plans to enroll 150 participants, but its current recruitment status is unclear.","Participants will be followed for 6 months after their baseline visit to assess documentation of screening and family satisfaction.",135,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]