- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03862443
BEhavioral EConomics for Oral Health iNnovation Pilot Trial (BEECON Pilot)
1. března 2019 aktualizováno: University of California, San Francisco
Influence of Financial Incentives on Oral Disease Management in Young Children: A Randomized Pilot Trial
This Phase I randomized pilot trial will assess the efficacy of a fixed incentive payment program and drawing incentive payment program versus a control program to promote early childhood caries (ECC) preventive health behaviors (i.e., toothbrushing performance and dental visit attendance) for young children of predominantly Latino parents/caregivers enrolled in/waitlisted for Early Head Start (EHS) home visit programs.
Přehled studie
Postavení
Dokončeno
Intervence / Léčba
Detailní popis
If both groups are acceptable and feasible, the reward group with toothbrushing outcomes at least 20% better than the other one (and the control) will be chosen for a future Phase II/III trial; if they are similar, the fixed monetary reward will be used because it is simpler to explain, monitor, and implement.
Typ studie
Intervenční
Zápis (Aktuální)
36
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
California
-
Santa Monica, California, Spojené státy, 90405-1828
- Venice Family Clinic Children First Early Head Start
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
6 měsíců až 3 roky (Dítě)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria for Parent/Caregiver:
- Provide signed and dated informed consent form in English or Spanish.
- Agree to comply with all study procedures and be available for the duration of the study visit.
- Male or female, aged 18 and older.
- Speak, read, and write either English or Spanish.
- Be a parent or caregiver of a child at least 6 months old but less than 3.5 years (42 months), with at least 2 fully erupted teeth and enrolled in, or waitlisted for, one of the three participating Los Angeles County EHS home visit programs.
- Not be planning to move residence for the next 6 months outside the greater Los Angeles area.
- Own a smartphone with the Google Play or iTunes store and be willing to download the smart powered TB app
- Be willing to be contacted via text-messaging (SMS) for study related notifications, such as incentives earned or reminders to sync the TB
Exclusion Criteria:
- Known allergic reaction to components of the study product(s).
- Uncooperative or behaviorally unsuited (assessed during a TB prophylaxis at the initial baseline study visit).
- A sibling of a child already enrolled in the study (the family's oldest child in the eligible age range will be the study child).
- Enrolled in foster care.
- Anything else that would place him/her at increased health risk or preclude the individual's full compliance with or completion of the study.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: Fixed Incentive
Eligible to earn a weekly payment during the 2-month incentive intervention period.
Possible weekly winnings depend on toothbrushing performance collected through smart powered toothbrush synced to a smartphone app: low adherence threshold (brushing child's teeth once per day for 7 days in a week) will win $5; high adherence threshold (brushing twice per day for 14 days in a week) will win $10.
|
The Fixed Incentive intervention is a fixed reward, in which participants are eligible for fixed weekly payments based on toothbrushing performance collected through smart powered toothbrush synced to a smartphone app.
|
Experimentální: Drawing Incentive
Eligible to earn a weekly drawing entry with different winning probabilities during the 2-month incentive intervention period.
Possible weekly winnings depend on toothbrushing performance collected through smart powered toothbrush synced to a smartphone app: low adherence threshold (brushing child's teeth once per day for 7 days in a week) will have an 18% chance of winning $25 and a 1% chance of winning $50 (expected $5 payout); high adherence threshold (brushing twice per day for 14 days in a week) will have a 34% chance of winning $25 and a 3% chance of winning $50 (expected $10 payout).
|
The Drawing Incentive intervention is a drawing reward, in which participants are eligible for weekly payments based on toothbrushing performance collected through smart powered toothbrush synced to a smartphone app.
|
Žádný zásah: Control - Delayed Incentive
No rewards during the first 2-months, but information on toothbrushing performance collected through smart powered toothbrush synced to a smartphone app.
After the Month 2 follow-up visit, may opt to participate in a delayed 2-month open label extension to earn the same monetary rewards the fixed incentive intervention group could earn Baseline through Month 2.
Not a formal part of this trial, but rather a necessary condition to assure all participating parents/caregivers have the chance to earn the same monetary incentives.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Mean number of qualifying half-day toothbrushing episodes per week
Časové okno: Baseline visit through the Month 2 visit
|
Mean number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth.
(A Bluetooth-recorded toothbrushing episode qualifies if it lasts at least one minute within one of 14 half-day windows in the week.)
|
Baseline visit through the Month 2 visit
|
Proportion of parents/caregivers attending a dental visit
Časové okno: Month 2 visit
|
In the subset of children at baseline with no dental visit in the EHS ChildPlus health module, whether or not the child has a ChildPlus documented dental visit at the two-month follow-up.
|
Month 2 visit
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Proportion of weeks the parent/caregiver synced toothbrushing data with the app
Časové okno: Baseline visit through Month 2 visit
|
Proportion of weeks the parent/caregiver synced toothbrushing data with the app
|
Baseline visit through Month 2 visit
|
Mean number of days per week with parent/caregiver-reported twice daily brushing
Časové okno: Baseline visit through the Month 2 visit
|
Twice daily brushing with fluoridated toothpaste, based on parent/caregiver-reported frequency diaries
|
Baseline visit through the Month 2 visit
|
Fluoridated toothpaste use
Časové okno: Baseline visit through the Month 2 visit
|
Change in child toothpaste pump weight
|
Baseline visit through the Month 2 visit
|
Child plaque score
Časové okno: Month 2 visit
|
The child's Debris Index component (plaque score) of the Simplified Oral Hygiene Index (Greene and Vermillion) modified to include only maxillary incisor teeth after disclosing with plaque solution.
The scale (which is a mean value) range is 0 (no debris or stain) to 3 (soft debris covering more than two thirds of the exposed tooth surface).
|
Month 2 visit
|
EHS site participation
Časové okno: Month 0
|
Willingness of LA County EHS to sign memoranda of understanding
|
Month 0
|
EHS staff participation
Časové okno: Month 0
|
Willingness of EHS staff participation in assisting with recruitment
|
Month 0
|
Proportion of parents/caregivers who consent
Časové okno: Baseline visit
|
Willingness of parents/caregivers to provide informed consent and approve access to ChildPlus dental visit data
|
Baseline visit
|
Proportion of parents/caregivers willing to be randomized
Časové okno: Baseline visit
|
Willingness of parents/caregivers to be randomized to a study arm as part of the consenting process
|
Baseline visit
|
Proportion of parents/caregivers adhering to study procedures
Časové okno: Baseline visit through the Month 2 visit
|
Willingness of parents/caregivers to adhere to study procedures, including completing questionnaire instruments, bringing toothbrushing frequency diaries to 2-month follow-up visit, and bringing toothpaste pump to 2-month follow-up visit
|
Baseline visit through the Month 2 visit
|
Proportion of children who cooperate
Časové okno: Baseline visit through the Month 2 visit
|
Willingness of child to cooperate with study procedures, including dental screening, extraoral photo, and plaque assessment
|
Baseline visit through the Month 2 visit
|
Proportion of parents/caregivers willing to use the toothpaste pump
Časové okno: Baseline visit through the Month 2 visit
|
Willingness to use the toothpaste pump (percentage with any use and percentage change in pump weight)
|
Baseline visit through the Month 2 visit
|
Feasibility of measuring toothbrushing frequency with diaries
Časové okno: Month 2 visit
|
Bringing toothbrushing diaries to the follow-up visit and willingness to provide them to study staff
|
Month 2 visit
|
Feasibility of using toothpaste pump weight as a measure of usage
Časové okno: Month 2 visit
|
Bringing the toothpaste pump to the follow-up visit for weighing
|
Month 2 visit
|
Proportion of parents/caregivers willing to use the disclosing solution
Časové okno: Baseline visit and Month 2 visit
|
Willingness of children to comply with the plaque disclosing procedure
|
Baseline visit and Month 2 visit
|
Proportion of parents/caregivers willing to use photographs for central assessment
Časové okno: Baseline visit and Month 2 visit
|
Willingness of the child to allow photographs, the ability to transmit the photographs securely, and the ability of the central clinician to score them reliably and confidently
|
Baseline visit and Month 2 visit
|
Proportion of parents/caregivers willing to use smart powered toothbrush
Časové okno: Baseline visit through Month 2 visit
|
Willingness to use the smart powered toothbrush handle (percentage with any brushing data)
|
Baseline visit through Month 2 visit
|
Comfort with smart powered toothbrush
Časové okno: Baseline visit through Month 2 visit
|
Child and parent comfort level with using the smart powered toothbrush
|
Baseline visit through Month 2 visit
|
Proportion of parents/caregivers willing to use smartphone app
Časové okno: Baseline visit
|
Willingness to download the smartphone app and keep it for the duration of the study
|
Baseline visit
|
Proportion of parents/caregivers willing to receive text messages
Časové okno: Baseline visit
|
Willingness to be contacted with study-related text messages each week during the intervention period
|
Baseline visit
|
Feasibility of syncing toothbrush to app
Časové okno: Baseline visit
|
Successfully synced the toothbrush to app during baseline visit
|
Baseline visit
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: James G Kahn, MD, MPH, University of California, San Francisco
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
10. května 2017
Primární dokončení (Aktuální)
13. srpna 2017
Dokončení studie (Aktuální)
19. března 2018
Termíny zápisu do studia
První předloženo
14. února 2019
První předloženo, které splnilo kritéria kontroly kvality
1. března 2019
První zveřejněno (Aktuální)
5. března 2019
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
5. března 2019
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
1. března 2019
Naposledy ověřeno
1. března 2019
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 16-19968
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Zubní kaz
-
King's College LondonDokončenoDental Crowding | Vibrační síla | Pevné ortodontické aparáty
-
Cairo UniversityNeznámýBlack Stain Dental, Dental Black Stain, Black Stain*, Black Skvrny, Zubní skvrny
-
Columbia UniversityDokončeno
-
Ahmed Talaat Hussein AliDokončenoZubní malokluze | Dental CrowdingEgypt
-
University of North Carolina, Chapel HillDokončenoMalokluze | Stlačování zubů | Dental CrowdingSpojené státy
-
University of HelsinkiCity of VantaaNábor
-
Hacettepe UniversityDokončenoKorunky (MeSH Unique ID: D003442), Single Tooth | Dental Porcelain (MeSH Unique ID: D003776)