- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07819747
Resources and Education for Addressing Chronic Health (REACH) (REACH)
Piloting REACH - a School-Based Care Coordination Service Model to Support Youth With Asthma: A Systems Approach
Visão geral do estudo
Descrição detalhada
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Dr. Kelly M. Harris, PhD, CCC-SLP
- Número de telefone: 314-273-3242
- E-mail: kmharris@wustl.edu
Estude backup de contato
- Nome: Madelyn Yoo, MSOT
- Número de telefone: 314-400-8118
- E-mail: m.g.yoo@wustl.edu
Locais de estudo
-
-
Missouri
-
St Louis, Missouri, Estados Unidos, 63110
- Recrutamento
- WashU School of Medicine
-
Contato:
- Madelyn Yoo, MSOT
- Número de telefone: 314-400-8118
- E-mail: m.g.yoo@wustl.edu
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
Aceita Voluntários Saudáveis
Descrição
Parents (N=200)/Children (N=200)
Inclusion criteria for recruited parents/children:
- parents/caregivers with at least one child with asthma or present to the nurse with asthma symptoms in the partner school district,
- child with asthma must have a diagnosis of asthma or suspected asthma due to asthma symptom-related healthcare utilization and/or multiple visits to the school nurse (>1)
- attend a school in one of the partner school districts
- have access to email and a computer or other mobile device
- receive care within the BJH/ WUSM system (an indicator of participation in the electronic health record system).
Exclusion Criteria for recruited families:
- Child does not have asthma and do not present to school nurse with asthma symptoms
- Child does not attend one of the identified schools in a partner school district
- Children in foster care or wards of the state
School Nurses (Implementers) (N=15)
Inclusion Criteria for school nurses:
- Employed by partner school district and work in an identified building
- Provide care to students with asthma or present with asthma symptoms
Exclusion Criteria for school nurses:
- Do not work for partner school district or for an identified building
Providers (N =15)
Inclusion Criteria for Providers:
- Provide care to a child participant on the study
Exclusion Criteria for Providers:
- Do not provide care to a child participant on the study
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: REACH
Consists of school nurses who serve as both participants and REACH intervention implementers, students and their caregivers, and student providers.
Though there are several participant types, there is only 1 experimental group.
All participants serve as their own controls.
|
The REACH intervention which includes (a) a strategic communication or messaging and dissemination strategy to build school and family relationships and trust, (b) capacity building activities to improve asthma knowledge and awareness through asthma education and resource provided both digitally and in-person, and (c) a tool or dashboard that allows records and communication sharing across healthcare and educational systems to facilitate care coordination (REACH tool).
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Asthma knowledge and awareness
Prazo: Measured at baseline and at study completion (average of 1 year)
|
Measured via survey.
Data collected from student caregivers and school nurse implementers.
|
Measured at baseline and at study completion (average of 1 year)
|
|
Implementation
Prazo: Measured at mid-trial (school nurses only) and at study completion (average of 1 year)
|
Measured via surveys and post-trial semi-structured focus group/interview.
Data collected from student caregivers, school nurse implementers, and providers.
|
Measured at mid-trial (school nurses only) and at study completion (average of 1 year)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Asthma guideline adherence
Prazo: Measured at baseline and at study completion (average of 1 year)
|
Measured via survey.
Data collected from student caregivers and school nurse implementers.
|
Measured at baseline and at study completion (average of 1 year)
|
|
School connectedness
Prazo: Measured at baseline and at study completion (average of 1 year)
|
Measured via survey.
Data collected from student caregivers.
|
Measured at baseline and at study completion (average of 1 year)
|
|
Healthcare utilization
Prazo: 24 months prior to intervention, during intervention, and 12 months following intervention completion
|
Number of asthma related emergency department visits, hospitalizations, and clinic/office visits collected from the electronic medical record.
|
24 months prior to intervention, during intervention, and 12 months following intervention completion
|
|
School Attendance/Absence
Prazo: 24 months prior to intervention, during intervention, and 12 months following intervention completion
|
Number of days student is attends school, and number of school absence days.
Data provided by the school.
|
24 months prior to intervention, during intervention, and 12 months following intervention completion
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 202605145
- SCH205081 (Número de outro subsídio/financiamento: William T Grant Foundation)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
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