- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Descrizione dettagliata
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Dr. Kelly M. Harris, PhD, CCC-SLP
- Numero di telefono: 314-273-3242
- Email: kmharris@wustl.edu
Backup dei contatti dello studio
- Nome: Madelyn Yoo, MSOT
- Numero di telefono: 314-400-8118
- Email: m.g.yoo@wustl.edu
Luoghi di studio
-
-
Missouri
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St Louis, Missouri, Stati Uniti, 63110
- Reclutamento
- WashU School of Medicine
-
Contatto:
- Madelyn Yoo, MSOT
- Numero di telefono: 314-400-8118
- Email: m.g.yoo@wustl.edu
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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).
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Asthma knowledge and awareness
Lasso di tempo: 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
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Asthma guideline adherence
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
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Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 202605145
- SCH205081 (Altro numero di sovvenzione/finanziamento: William T Grant Foundation)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Periodo di condivisione IPD
Criteri di accesso alla condivisione IPD
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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