Coordinated Oral Health Promotion (CO-OP) Chicago
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Illinois
-
Blue Island, Illinois, États-Unis, 60406
- CEDA WIC Center Blue Island
-
Chicago, Illinois, États-Unis, 60604
- Chicago Department of Public Health WIC Centers (Greater Lawn Health Center, Friend Family Health Center, Westside Health Partnership)
-
Chicago, Illinois, États-Unis, 60608
- Mile Square Health Center (Main, Englewood, Cicero, South Shore, Back of the Yards)
-
Chicago, Illinois, États-Unis, 60612
- University of Illinois at Chicago Outpatient Care Center
-
Chicago, Illinois, États-Unis, 60617
- Aunt Martha's Southeast Side Community Health Center
-
Chicago, Illinois, États-Unis, 60629
- Vida Pediatrics
-
Chicago, Illinois, États-Unis, 60661
- CEDA WIC Centers (Diversey, Irving Park)
-
Chicago Heights, Illinois, États-Unis, 60411
- Aunt Martha's Pediatric Health & Wellness Center
-
Harvey, Illinois, États-Unis, 60426
- CEDA WIC Center Harvey
-
Maywood, Illinois, États-Unis, 60153
- CEDA WIC Center Maywood
-
Oak Park, Illinois, États-Unis, 60304
- CEDA WIC Oak Park
-
South Holland, Illinois, États-Unis, 60473
- Aunt Martha's South Holland Community Health Center
-
Summit, Illinois, États-Unis, 60501
- CEDA WIC Summit
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
CHWs are non-clinical people who provide education, care coordination, and support to families.
|
|
Aucune intervention: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Parent-reported Tooth Brushing Frequency
Délai: 12-months post-randomization
|
parents will be asked how often the child's teeth are brushed
|
12-months post-randomization
|
|
Child Dental Plaque Score
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2017-1090
- UH3DE025483 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Délai de partage IPD
Critères d'accès au partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .