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Screening For Social Determinants Of Health In Routine Diabetes Care (SDOH)

15 juli 2026 uppdaterad av: Lauren Wisk, PhD, University of California, Los Angeles

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

150

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Förenta staterna
    • California
      • Los Angeles, California, Förenta staterna, 90095
        • University of California, Los Angeles
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: Behandling som vanligt
Experimentell: SDOH Screening and Intervention Program
Beteende: 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 social work team. Patients/families 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/families will subsequently receive follow-up calls every two weeks until the referral is complete or the patient/family discloses that their identified food insecurity is resolved.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Documentation of SDOH screening
Tidsram: Baseline visit, final follow-up (6 months post-baseline)
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)
Family-reported satisfaction with screening (acceptability)
Tidsram: All three survey time points (pre, immediate post, 6-month post)
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/post surveys.
All three survey time points (pre, immediate post, 6-month post)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Hemoglobin A1c
Tidsram: baseline and 6 months follow-up
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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of California, Los Angeles

Utredare

  • Huvudutredare: Lauren Wisk, PhD, Lauren Wisk

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 september 2026

Primärt slutförande (Beräknad)

1 september 2028

Avslutad studie (Beräknad)

1 september 2028

Studieregistreringsdatum

Först inskickad

15 juni 2026

Först inskickad som uppfyllde QC-kriterierna

15 juli 2026

Första postat (Faktisk)

16 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

16 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

15 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • IRB#25-0333

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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