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BEhavioral EConomics for Oral Health iNnovation Pilot Trial (BEECON Pilot)

1. marts 2019 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

36

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Santa Monica, California, Forenede Stater, 90405-1828
        • Venice Family Clinic Children First Early Head Start

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

6 måneder til 3 år (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: Fixed Incentive
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.
Eksperimentel: 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).
Adfærdsmæssigt: Drawing Incentive
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.
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean number of qualifying half-day toothbrushing episodes per week
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of weeks the parent/caregiver synced toothbrushing data with the app
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline visit through the Month 2 visit
Change in child toothpaste pump weight
Baseline visit through the Month 2 visit
Child plaque score
Tidsramme: 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
Tidsramme: Month 0
Willingness of LA County EHS to sign memoranda of understanding
Month 0
EHS staff participation
Tidsramme: Month 0
Willingness of EHS staff participation in assisting with recruitment
Month 0
Proportion of parents/caregivers who consent
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline visit
Successfully synced the toothbrush to app during baseline visit
Baseline visit

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of California, San Francisco

Samarbejdspartnere

University of California, Los Angeles

Efterforskere

  • Ledende efterforsker: James G Kahn, MD, MPH, University of California, San Francisco

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. maj 2017

Primær færdiggørelse (Faktiske)

13. august 2017

Studieafslutning (Faktiske)

19. marts 2018

Datoer for studieregistrering

Først indsendt

14. februar 2019

Først indsendt, der opfyldte QC-kriterier

1. marts 2019

Først opslået (Faktiske)

5. marts 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. marts 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. marts 2019

Sidst verificeret

1. marts 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 16-19968

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Caries i tænderne

Kliniske forsøg med Fixed Incentive

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Tanzania

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner