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

15 juli 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

150

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • California
      • Los Angeles, California, Verenigde Staten, 90095
        • University of California, Los Angeles
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: Behandeling zoals gebruikelijk
Experimenteel: SDOH Screening and Intervention Program
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Documentation of SDOH screening
Tijdsspanne: 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)
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Hemoglobin A1c
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of California, Los Angeles

Onderzoekers

  • Hoofdonderzoeker: Lauren Wisk, PhD, Lauren Wisk

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

1 september 2028

Studie voltooiing (Geschat)

1 september 2028

Studieregistratiedata

Eerst ingediend

15 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

15 juli 2026

Eerst geplaatst (Werkelijk)

16 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

16 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

15 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • IRB#25-0333

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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