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Not yet recruiting NCT07706803

Screening For Social Determinants Of Health In Routine Diabetes Care

No phase Interventional Type 1 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Social Determinants of Health (SDOH) Screening and Referral.
Who it may be relevant to
Registry conditions: Type 1 Diabetes. Basic parameters: up to 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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. Outcomes 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/post 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.

Interventions

  • 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/families for SDOH and respond based on the results of the screen. Patients/families 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 so

Primary outcome measures

  • Documentation of SDOH screening [Time frame: Baseline visit, final follow-up (6 months post-baseline)]
  • Family-reported satisfaction with screening (acceptability) [Time frame: All three survey time points (pre, immediate post, 6-month post)]
Secondary outcome measures (1)
  • Change in Hemoglobin A1c [Time frame: baseline and 6 months follow-up]

Eligibility criteria

Inclusion criteria

  • 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/or 2) parents/legal 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.

Exclusion criteria

  • 1\) patients who are over 21 years old and diagnosed with Type 2 Diabetes or prediabetes, and 2) parents/legal guardians of a child with type 2 diabetes or prediabetes and whose child is over 21 years old.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • University of California, Los Angeles — Los Angeles

Identifiers

NCT: NCT07706803 · IRB#25-0333

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗