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Coordinated Oral Health Promotion (CO-OP) Chicago

13. oktober 2022 opdateret af: Molly A. Martin, University of Illinois at Chicago
This study assesses the impact of oral health promotion delivered by community health workers in medical clinics, Women, Infants and Children (WIC) centers, and family homes. Investigators will assess oral health behaviors in children aged 0 to 3.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Dental caries is the most common chronic disease of childhood; an estimated 28% of children nationally aged 5 years and below have untreated dental disease. Pediatric dental caries are associated with pain, more severe infections, malnutrition, speech difficulties, poor school performance, cosmetic problems, and an overall lower quality of life. Similar to other chronic diseases, oral health disparities are seen with higher caries prevalence and worse outcomes in children from low income urban families and in children of African American and Latino ethnicity. These disparities have been demonstrated locally in Chicago. Many interventions have been implemented to attempt to reverse these disparities. Some involve public policy (fluorinated water), some are educational campaigns targeting individuals, while others focus on providing increased education and services through primary healthcare providers. Many of these programs have demonstrated efficacy but the disparities in oral health persist. The investigators propose this is because the interventions to date do not target the family as a whole and also have not targeted multiple levels simultaneously.

COordinated Oral health Promotion (CO-OP) Chicago brings together a team of clinical pediatricians and dentists, health researchers, and policy experts to rigorously test the ability of multiple oral health promotion interventions, both alone and in combination, to improve child and family oral health. The primary intervention is family-focused education and support from community health workers (CHWs). CO-OP Chicago will test the impact of a family-focused CHW intervention for oral health promotion when applied in clinical, community, and home settings. The primary study objective is to evaluate the efficacy of a one-year oral health CHW intervention, compared to usual care, to improve self-reported brushing frequency and observed plaque score in low income urban children under the age of 3 years old. The study's exploratory aim is to determine if the oral health CHW intervention impact on child tooth brushing behaviors varies when the CHWs are based out of a medical clinic compared to a community WIC center.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

420

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Illinois
      • Blue Island, Illinois, Forenede Stater, 60406
        • CEDA WIC Center Blue Island
      • Chicago, Illinois, Forenede Stater, 60604
        • Chicago Department of Public Health WIC Centers (Greater Lawn Health Center, Friend Family Health Center, Westside Health Partnership)
      • Chicago, Illinois, Forenede Stater, 60608
        • Mile Square Health Center (Main, Englewood, Cicero, South Shore, Back of the Yards)
      • Chicago, Illinois, Forenede Stater, 60612
        • University of Illinois at Chicago Outpatient Care Center
      • Chicago, Illinois, Forenede Stater, 60617
        • Aunt Martha's Southeast Side Community Health Center
      • Chicago, Illinois, Forenede Stater, 60629
        • Vida Pediatrics
      • Chicago, Illinois, Forenede Stater, 60661
        • CEDA WIC Centers (Diversey, Irving Park)
      • Chicago Heights, Illinois, Forenede Stater, 60411
        • Aunt Martha's Pediatric Health & Wellness Center
      • Harvey, Illinois, Forenede Stater, 60426
        • CEDA WIC Center Harvey
      • Maywood, Illinois, Forenede Stater, 60153
        • CEDA WIC Center Maywood
      • Oak Park, Illinois, Forenede Stater, 60304
        • CEDA WIC Oak Park
      • South Holland, Illinois, Forenede Stater, 60473
        • Aunt Martha's South Holland Community Health Center
      • Summit, Illinois, Forenede Stater, 60501
        • CEDA WIC Summit

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

6 måneder til 3 år (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

Caregiver:

  • Provide a signed and dated informed consent form
  • Age 18 or older
  • Be the primary caregiver of a child age 6-36 months old. The primary caregiver is defined for this study as the person (or one of the people) who is consistently responsible for the child's daily routines and who is a legal guardian.
  • If a child lives in multiple households, the caregiver must live with the child at least 5 days of the week.
  • The child must be an active patient/client in the clinic/center where recruited.
  • Speak English or Spanish
  • Willing to comply with all study procedures and be available for the duration of the study

Child:

  • Age 6-36 months old
  • An active patient/client in the clinic/center where recruited
  • A minimum of two fully erupted central maxillary incisors

Exclusion Criteria:

  • Child with medical condition that limits his or her ability to conduct the study activities (such as severe developmental or cognitive delay, ventilator or oxygen dependence, oral aversion, severe facial deformities)
  • Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study
  • Anything that would place the research or intervention staff at increased risk

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: CHW Arm
The intervention is community health worker (CHW) services. CHWs trained in oral health will be assigned to half of the sites. Participants in these sites will be offered four in-person visits and follow-up phone calls over 12-months. These visits can occur at the location of the family's preference (recruitment site, home, or mutually-agreed upon other location). A core curriculum of oral health topics will be covered during visits, with an emphasis on developing and sustaining healthy oral health management routines for the entire family.
Adfærdsmæssigt: Community Health Worker (CHW) services
CHWs are non-clinical people who provide education, care coordination, and support to families.
Ingen indgriben: Wait-list Control Arm
This arm will receive usual care. After completion of the final data collection at one year, participants and sites allotted to this arm will be offered CHW services.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Parent-reported Tooth Brushing Frequency
Tidsramme: 12-months post-randomization
parents will be asked how often the child's teeth are brushed
12-months post-randomization
Child Dental Plaque Score
Tidsramme: 12-months post-randomization
Disclosing solution is applied to child's teeth, images are taken, and plaque score is determined using the Oral health Index - Maxillary Incisor Score (OHI-MIS). The buccal surfaces of teeth #D, E, F, and G were scored from 0-3, with 3 being the worst (plaque on more than 2/3 of tooth surface) and 0 being the best (no plaque present). The four individual tooth scores (or less if child did not have four teeth) were then added and divided by the number of teeth for a final average score ranging from 0-3.
12-months post-randomization

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Illinois at Chicago

Samarbejdspartnere

National Institute of Dental and Craniofacial Research (NIDCR)

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. januar 2018

Primær færdiggørelse (Faktiske)

20. august 2020

Studieafslutning (Faktiske)

20. august 2020

Datoer for studieregistrering

Først indsendt

22. december 2017

Først indsendt, der opfyldte QC-kriterier

10. januar 2018

Først opslået (Faktiske)

12. januar 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. oktober 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. oktober 2022

Sidst verificeret

1. oktober 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2017-1090
  • UH3DE025483 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Three years after the end of the CO-OP Chicago research activity, data will be publicly released. Data will be maintained by the study team, in partnership with the community clinical partner. Registration will be required to access or download data files. Registered users will receive technical assistance with questions or problems from the Methodology Research Core (MRC) at the University of Illinois at Chicago's Institute for Health Research and Policy or from the UCSF Coordinating Center. A data sharing agreement will be required that will describe the conditions and restrictions of their use; limited data access will be made available only to users who successfully complete a rigorous approval process by both the investigators and the community partners. Data sets will be encrypted for transfer to approved investigators.

IPD-delingstidsramme

These details are not fully developed.

IPD-delingsadgangskriterier

These details are not fully developed.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Caries hos børn

Kliniske forsøg med Community Health Worker (CHW) services

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