- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo 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
Descripción general del estudio
Descripción detallada
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Dr. Kelly M. Harris, PhD, CCC-SLP
- Número de teléfono: 314-273-3242
- Correo electrónico: kmharris@wustl.edu
Copia de seguridad de contactos de estudio
- Nombre: Madelyn Yoo, MSOT
- Número de teléfono: 314-400-8118
- Correo electrónico: m.g.yoo@wustl.edu
Ubicaciones de estudio
-
-
Missouri
-
St Louis, Missouri, Estados Unidos, 63110
- Reclutamiento
- WashU School of Medicine
-
Contacto:
- Madelyn Yoo, MSOT
- Número de teléfono: 314-400-8118
- Correo electrónico: m.g.yoo@wustl.edu
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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).
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Asthma knowledge and awareness
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Asthma guideline adherence
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Enfermedades del sistema inmunológico
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Enfermedades bronquiales
- Enfermedades Pulmonares Obstructivas
- Hipersensibilidad Respiratoria
- Hipersensibilidad, Inmediata
- Hipersensibilidad
- Condiciones Patológicas, Signos y Síntomas
- Asma
- Enfermedad
Otros números de identificación del estudio
- 202605145
- SCH205081 (Otro número de subvención/financiamiento: William T Grant Foundation)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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. .