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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

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

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

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

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
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.
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.
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).
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.
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.

¿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
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
Periodo de tiempo: 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

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
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
Periodo de tiempo: 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
Periodo de tiempo: Baseline visit through the Month 2 visit
Change in child toothpaste pump weight
Baseline visit through the Month 2 visit
Child plaque score
Periodo de tiempo: 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
Periodo de tiempo: Month 0
Willingness of LA County EHS to sign memoranda of understanding
Month 0
EHS staff participation
Periodo de tiempo: Month 0
Willingness of EHS staff participation in assisting with recruitment
Month 0
Proportion of parents/caregivers who consent
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Baseline visit
Successfully synced the toothbrush to app during baseline visit
Baseline visit

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

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

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. .

Ensayos clínicos sobre Caries dental

Ensayos clínicos sobre Fixed Incentive

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