- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03862443
BEhavioral EConomics for Oral Health iNnovation Pilot Trial (BEECON Pilot)
1 mars 2019 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
36
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
California
-
Santa Monica, California, États-Unis, 90405-1828
- Venice Family Clinic Children First Early Head Start
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
6 mois à 3 ans (Enfant)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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.
|
Expérimental: 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.
|
Aucune intervention: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Mean number of qualifying half-day toothbrushing episodes per week
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Proportion of weeks the parent/caregiver synced toothbrushing data with the app
Délai: 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
Délai: 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
Délai: Baseline visit through the Month 2 visit
|
Change in child toothpaste pump weight
|
Baseline visit through the Month 2 visit
|
Child plaque score
Délai: 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
Délai: Month 0
|
Willingness of LA County EHS to sign memoranda of understanding
|
Month 0
|
EHS staff participation
Délai: Month 0
|
Willingness of EHS staff participation in assisting with recruitment
|
Month 0
|
Proportion of parents/caregivers who consent
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline visit
|
Successfully synced the toothbrush to app during baseline visit
|
Baseline visit
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: James G Kahn, MD, MPH, University of California, San Francisco
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
10 mai 2017
Achèvement primaire (Réel)
13 août 2017
Achèvement de l'étude (Réel)
19 mars 2018
Dates d'inscription aux études
Première soumission
14 février 2019
Première soumission répondant aux critères de contrôle qualité
1 mars 2019
Première publication (Réel)
5 mars 2019
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
5 mars 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
1 mars 2019
Dernière vérification
1 mars 2019
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 16-19968
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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 .
Essais cliniques sur Caries dentaires
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaRecrutementComplications de la thérapie CAR-TItalie
-
The Lymphoma Academic Research OrganisationNovartis; Gilead SciencesRecrutementÉligible en hématopathologie ou traitement CAR-t CellFrance
-
Shanghai International Medical CenterInconnueTumeur solide avancée | PD-1 Anticorps | Cellules CAR-TChine
-
Ningbo Cancer HospitalInconnueMalignités avancées | PD-1 Anticorps | Cellules CAR-TChine
-
Stiftung Swiss Tumor InstituteKlinik Hirslanden, Zurich; Palleos Healthcare GmbHRecrutementMesures des résultats rapportés par les patients | Thérapie CAR T-CellSuisse
-
Merz Pharmaceuticals GmbHComplétéN/A, car aucune condition médicale spécifique ne sera traitéeAllemagne
-
Henan Cancer HospitalFundamenta Therapeutics, Ltd.Pas encore de recrutementAllogénique, CAR-T, séquestration de protéines, non modifié par des gènesChine
-
Ruijin HospitalRecrutement
-
Shanghai General Hospital, Shanghai Jiao Tong University...RecrutementCellule CAR-T | Ph Positif TOUS | DasatinibChine
-
Insel Gruppe AG, University Hospital BernRecrutementImmunité vaccinale chez les receveurs de thérapie cellulaire CAR-TSuisse