ENLaCE Pilot Study
Using MEDUCATION to Improve Asthma Medication Device Technique
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
North Carolina
-
Thomasville, North Carolina, Förenta staterna, 27360
- Thomasville Pediatrics
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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).
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Video intervention
Group that will watch the Meducation inhaler device technique videos.
|
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.
|
|
Övrig: Control
This group will watch a nutrition video.
|
Children in this group will watch a 2-minute nutrition video.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in inhaler, turbuhaler, and diskus technique
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Child inhaler self-efficacy
Tidsram: 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?"
|
Baseline and 1-month follow-up
|
|
Asthma Control
Tidsram: 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.
|
Baseline and 1-month follow-up
|
Samarbetspartners och utredare
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 12-1008
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .