BEhavioral EConomics for Oral Health iNnovation Pilot Trial (BEECON Pilot)
1 de março de 2019 atualizado 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.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Real)
36
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
California
-
Santa Monica, California, Estados Unidos, 90405-1828
- Venice Family Clinic Children First Early Head Start
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
6 meses a 3 anos (Filho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
|
|
Sem intervenção: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Mean number of qualifying half-day toothbrushing episodes per week
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Proportion of weeks the parent/caregiver synced toothbrushing data with the app
Prazo: 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
Prazo: 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
Prazo: Baseline visit through the Month 2 visit
|
Change in child toothpaste pump weight
|
Baseline visit through the Month 2 visit
|
|
Child plaque score
Prazo: 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
Prazo: Month 0
|
Willingness of LA County EHS to sign memoranda of understanding
|
Month 0
|
|
EHS staff participation
Prazo: Month 0
|
Willingness of EHS staff participation in assisting with recruitment
|
Month 0
|
|
Proportion of parents/caregivers who consent
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Baseline visit
|
Successfully synced the toothbrush to app during baseline visit
|
Baseline visit
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: James G Kahn, MD, MPH, University of California, San Francisco
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
10 de maio de 2017
Conclusão Primária (Real)
13 de agosto de 2017
Conclusão do estudo (Real)
19 de março de 2018
Datas de inscrição no estudo
Enviado pela primeira vez
14 de fevereiro de 2019
Enviado pela primeira vez que atendeu aos critérios de CQ
1 de março de 2019
Primeira postagem (Real)
5 de março de 2019
Atualizações de registro de estudo
Última Atualização Postada (Real)
5 de março de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
1 de março de 2019
Última verificação
1 de março de 2019
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 16-19968
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .