Coordinated Oral Health Promotion (CO-OP) Chicago
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
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Illinois
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Blue Island、Illinois、アメリカ、60406
- CEDA WIC Center Blue Island
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Chicago、Illinois、アメリカ、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、アメリカ、60608
- Mile Square Health Center (Main, Englewood, Cicero, South Shore, Back of the Yards)
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Chicago、Illinois、アメリカ、60612
- University of Illinois at Chicago Outpatient Care Center
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Chicago、Illinois、アメリカ、60617
- Aunt Martha's Southeast Side Community Health Center
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Chicago、Illinois、アメリカ、60629
- Vida Pediatrics
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Chicago、Illinois、アメリカ、60661
- CEDA WIC Centers (Diversey, Irving Park)
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Chicago Heights、Illinois、アメリカ、60411
- Aunt Martha's Pediatric Health & Wellness Center
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Harvey、Illinois、アメリカ、60426
- CEDA WIC Center Harvey
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Maywood、Illinois、アメリカ、60153
- CEDA WIC Center Maywood
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Oak Park、Illinois、アメリカ、60304
- CEDA WIC Oak Park
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South Holland、Illinois、アメリカ、60473
- Aunt Martha's South Holland Community Health Center
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Summit、Illinois、アメリカ、60501
- CEDA WIC Summit
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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介入なし：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Parent-reported Tooth Brushing Frequency
時間枠：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
時間枠：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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協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。