ENLaCE Pilot Study
Using MEDUCATION to Improve Asthma Medication Device Technique
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Asthma affects almost 10% of children and is the most common health condition reported by North Carolina public schools. Latino children have higher rates of uncontrolled asthma and more asthma-related emergency department visits than their White counterparts. No studies have evaluated Latino children's asthma device technique; poor technique can compromise medication delivery to the lungs.
The TraCS engagement core has spent the last 18 months developing the Expanding Networks for Latinos through Community Engagement (ENLaCE) network, which is comprised of over 15 organizations in the Greensboro area. The core would now like to conduct a feasibility study to determine whether ENLaCE can be used to recruit Latino children into a randomized, controlled trial (RCT) to improve their asthma medication device technique. This would be the first assessment of whether ENLaCE can be used to recruit patients.
MEDUCATION, an NIH-funded project developed by Polyglot Systems, Inc., has developed asthma device technique videos in Spanish and English. The member groups of ENLaCE believe the MEDUCATION videos are highly relevant for the Greensboro Latino community. Children will be recruited from two pediatric ENLaCE clinics in Greensboro and randomly assigned to watch device technique videos (experimental group; n=50) or a nutrition video (control group, n=50) in Spanish or English after a regularly-scheduled medical visit. Children's device technique will be assessed before and after the visit. Process evaluation data will also be collected.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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North Carolina
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Thomasville, North Carolina, Stati Uniti, 27360
- Thomasville Pediatrics
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
Children will be eligible if they:
- are ages 8 through 16 years,
- are able to speak English or Spanish,
- can read the assent form,
- are present at the visit with an adult caregiver (parent or legal guardian) who can speak English or Spanish and who is at least 18 years of age,
- have mild, moderate, or severe persistent asthma, and
- are present for an asthma-related visit (either acute or scheduled).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Video intervention
Group that will watch the Meducation inhaler device technique videos.
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2-minute video that displays proper inhaler, diskus, and turbuhaler technique.
The video will only be watched once at the medical visit.
Children in this group will be given a wallet card so they can access the video via the Internet after leaving the asthma clinic.
|
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Altro: Control
This group will watch a nutrition video.
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Children in this group will watch a 2-minute nutrition video.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in inhaler, turbuhaler, and diskus technique
Lasso di tempo: Baseline and 1-month follow-up
|
Children will demonstrate how they use their metered-dose inhalers, turbuhalers, and diskuses using empty devices.
The research assistant will record the number of steps performed correctly.
Correct use of inhalers, diskuses, and turbuhalers will be measured as continuous variables.
|
Baseline and 1-month follow-up
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Child inhaler self-efficacy
Lasso di tempo: Baseline and 1-month follow-up
|
Child inhaler self-efficacy will be measured as a continuous variable using 1 item from the Bursch asthma management self-efficacy measure, "How sure are you that you can use your inhaler correctly?"
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Baseline and 1-month follow-up
|
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Asthma Control
Lasso di tempo: Baseline and 1-month follow-up
|
The Asthma Control Test is a 5-item questionnaire assessing asthma symptoms, use of rescue medications, and the effect of asthma on daily functioning.
Scores range from 5 (poor control) to 25 (complete control).
Studies show that the Asthma Control Test is reliable, valid, and responsive to temporal changes in asthma control.
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Baseline and 1-month follow-up
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Collaboratori e investigatori
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 12-1008
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .