- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03862443
BEhavioral EConomics for Oral Health iNnovation Pilot Trial (BEECON Pilot)
1 de marzo de 2019 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
36
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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California
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Santa Monica, California, Estados Unidos, 90405-1828
- Venice Family Clinic Children First Early Head Start
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
6 meses a 3 años (Niño)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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.
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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.
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Experimental: 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).
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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.
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Sin intervención: 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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Mean number of qualifying half-day toothbrushing episodes per week
Periodo de tiempo: Baseline visit through the Month 2 visit
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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.)
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Baseline visit through the Month 2 visit
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Proportion of parents/caregivers attending a dental visit
Periodo de tiempo: Month 2 visit
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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.
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Month 2 visit
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Proportion of weeks the parent/caregiver synced toothbrushing data with the app
Periodo de tiempo: Baseline visit through Month 2 visit
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Proportion of weeks the parent/caregiver synced toothbrushing data with the app
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Baseline visit through Month 2 visit
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Mean number of days per week with parent/caregiver-reported twice daily brushing
Periodo de tiempo: Baseline visit through the Month 2 visit
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Twice daily brushing with fluoridated toothpaste, based on parent/caregiver-reported frequency diaries
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Baseline visit through the Month 2 visit
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Fluoridated toothpaste use
Periodo de tiempo: Baseline visit through the Month 2 visit
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Change in child toothpaste pump weight
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Baseline visit through the Month 2 visit
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Child plaque score
Periodo de tiempo: Month 2 visit
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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).
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Month 2 visit
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EHS site participation
Periodo de tiempo: Month 0
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Willingness of LA County EHS to sign memoranda of understanding
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Month 0
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EHS staff participation
Periodo de tiempo: Month 0
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Willingness of EHS staff participation in assisting with recruitment
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Month 0
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Proportion of parents/caregivers who consent
Periodo de tiempo: Baseline visit
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Willingness of parents/caregivers to provide informed consent and approve access to ChildPlus dental visit data
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Baseline visit
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Proportion of parents/caregivers willing to be randomized
Periodo de tiempo: Baseline visit
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Willingness of parents/caregivers to be randomized to a study arm as part of the consenting process
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Baseline visit
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Proportion of parents/caregivers adhering to study procedures
Periodo de tiempo: Baseline visit through the Month 2 visit
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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
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Baseline visit through the Month 2 visit
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Proportion of children who cooperate
Periodo de tiempo: Baseline visit through the Month 2 visit
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Willingness of child to cooperate with study procedures, including dental screening, extraoral photo, and plaque assessment
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Baseline visit through the Month 2 visit
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Proportion of parents/caregivers willing to use the toothpaste pump
Periodo de tiempo: Baseline visit through the Month 2 visit
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Willingness to use the toothpaste pump (percentage with any use and percentage change in pump weight)
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Baseline visit through the Month 2 visit
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Feasibility of measuring toothbrushing frequency with diaries
Periodo de tiempo: Month 2 visit
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Bringing toothbrushing diaries to the follow-up visit and willingness to provide them to study staff
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Month 2 visit
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Feasibility of using toothpaste pump weight as a measure of usage
Periodo de tiempo: Month 2 visit
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Bringing the toothpaste pump to the follow-up visit for weighing
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Month 2 visit
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Proportion of parents/caregivers willing to use the disclosing solution
Periodo de tiempo: Baseline visit and Month 2 visit
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Willingness of children to comply with the plaque disclosing procedure
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Baseline visit and Month 2 visit
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Proportion of parents/caregivers willing to use photographs for central assessment
Periodo de tiempo: Baseline visit and Month 2 visit
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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
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Baseline visit and Month 2 visit
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Proportion of parents/caregivers willing to use smart powered toothbrush
Periodo de tiempo: Baseline visit through Month 2 visit
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Willingness to use the smart powered toothbrush handle (percentage with any brushing data)
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Baseline visit through Month 2 visit
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Comfort with smart powered toothbrush
Periodo de tiempo: Baseline visit through Month 2 visit
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Child and parent comfort level with using the smart powered toothbrush
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Baseline visit through Month 2 visit
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Proportion of parents/caregivers willing to use smartphone app
Periodo de tiempo: Baseline visit
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Willingness to download the smartphone app and keep it for the duration of the study
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Baseline visit
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Proportion of parents/caregivers willing to receive text messages
Periodo de tiempo: Baseline visit
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Willingness to be contacted with study-related text messages each week during the intervention period
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Baseline visit
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Feasibility of syncing toothbrush to app
Periodo de tiempo: Baseline visit
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Successfully synced the toothbrush to app during baseline visit
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Baseline visit
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: James G Kahn, MD, MPH, University of California, San Francisco
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
10 de mayo de 2017
Finalización primaria (Actual)
13 de agosto de 2017
Finalización del estudio (Actual)
19 de marzo de 2018
Fechas de registro del estudio
Enviado por primera vez
14 de febrero de 2019
Primero enviado que cumplió con los criterios de control de calidad
1 de marzo de 2019
Publicado por primera vez (Actual)
5 de marzo de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de marzo de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
1 de marzo de 2019
Última verificación
1 de marzo de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 16-19968
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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