Coordinated Oral Health Promotion (CO-OP) Chicago
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Illinois
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Blue Island, Illinois, 미국, 60406
- CEDA WIC Center Blue Island
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Chicago, Illinois, 미국, 60604
- Chicago Department of Public Health WIC Centers (Greater Lawn Health Center, Friend Family Health Center, Westside Health Partnership)
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Chicago, Illinois, 미국, 60608
- Mile Square Health Center (Main, Englewood, Cicero, South Shore, Back of the Yards)
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Chicago, Illinois, 미국, 60612
- University of Illinois at Chicago Outpatient Care Center
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Chicago, Illinois, 미국, 60617
- Aunt Martha's Southeast Side Community Health Center
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Chicago, Illinois, 미국, 60629
- Vida Pediatrics
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Chicago, Illinois, 미국, 60661
- CEDA WIC Centers (Diversey, Irving Park)
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Chicago Heights, Illinois, 미국, 60411
- Aunt Martha's Pediatric Health & Wellness Center
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Harvey, Illinois, 미국, 60426
- CEDA WIC Center Harvey
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Maywood, Illinois, 미국, 60153
- CEDA WIC Center Maywood
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Oak Park, Illinois, 미국, 60304
- CEDA WIC Oak Park
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South Holland, Illinois, 미국, 60473
- Aunt Martha's South Holland Community Health Center
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Summit, Illinois, 미국, 60501
- CEDA WIC Summit
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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CHWs are non-clinical people who provide education, care coordination, and support to families.
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간섭 없음: 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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Parent-reported Tooth Brushing Frequency
기간: 12-months post-randomization
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parents will be asked how often the child's teeth are brushed
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12-months post-randomization
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Child Dental Plaque Score
기간: 12-months post-randomization
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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.
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12-months post-randomization
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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Community Health Worker (CHW) services에 대한 임상 시험
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Charles Drew University of Medicine and ScienceNational Library of Medicine (NLM); Los Angeles County Department of Public Health모병
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Wake Forest University Health SciencesNational Cancer Institute (NCI); National Institute on Minority Health and Health Disparities...초대로 등록
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University of California, San DiegoSan Ysidro Health Center완전한
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Abdul Latif Jameel Poverty Action LabMacArthur Foundation; Planned Parenthood Federation Nigeria완전한
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University of Wisconsin, MadisonNational Institute on Aging (NIA)완전한
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)모병조혈 및 림프 세포 신생물 | 진행성 악성 고형 신생물미국