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Coordinated Oral Health Promotion (CO-OP) Chicago

13 ottobre 2022 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

420

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 6 mesi a 3 anni (Bambino)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: Community Health Worker (CHW) services
CHWs are non-clinical people who provide education, care coordination, and support to families.
Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Parent-reported Tooth Brushing Frequency
Lasso di tempo: 12-months post-randomization
parents will be asked how often the child's teeth are brushed
12-months post-randomization
Child Dental Plaque Score
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Illinois at Chicago

Collaboratori

National Institute of Dental and Craniofacial Research (NIDCR)

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

20 gennaio 2018

Completamento primario (Effettivo)

20 agosto 2020

Completamento dello studio (Effettivo)

20 agosto 2020

Date di iscrizione allo studio

Primo inviato

22 dicembre 2017

Primo inviato che soddisfa i criteri di controllo qualità

10 gennaio 2018

Primo Inserito (Effettivo)

12 gennaio 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 ottobre 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 ottobre 2022

Ultimo verificato

1 ottobre 2022

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2017-1090
  • UH3DE025483 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Periodo di condivisione IPD

These details are not fully developed.

Criteri di accesso alla condivisione IPD

These details are not fully developed.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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