- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01405625
Improving Parent Understanding of Instructions About Asthma Care
Asthma has an especially great impact on poor urban children and their families. In addition to higher asthma prevalence and morbidity, those in low SES urban areas are at risk for low health literacy. Low health literacy is associated with poorer asthma outcomes. The provision of a written asthma action plan has been shown to help with asthma management and to reduce hospitalizations and ER visits. Poor urban families who may have low literacy may need an alternative asthma action plan to convey the treatment plan.
This pilot study proposes to investigate whether a plain language asthma action plan can improve parent understanding and adherence with medication instructions, compared to standard written materials, among parents of children with asthma. This is an RCT in which parents of children with asthma will be randomized to either receive a pictogram-based low literacy asthma action plan, or a standard action plan (AAAAI), to examine whether those who receive the low literacy plan have improved asthma action plan knowledge when presented with a hypothetical scenario.
A second part of the study is to examine whether providers who are given the pictogram-based low literacy asthma action plan will be more likely to counsel about certain aspects of asthma management (eg. need for daily medications even when sick, spacer use, confusion between everyday and rescue inhaler)compared to providers who receive use a standard action plan (AAAAI). This is an RCT in which pediatric providers are randomized to counsel a hypothetical patient using the pictogram-based action plan or the standard action plan (AAAAI).
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
New York
-
New York, New York, Förenta staterna, 10016
- NYU School of Medicine
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Parent study:
Inclusion Criteria:
- Primary caregiver / parent / legal guardian of child 2-12 years old
- Child with diagnosis of asthma
Exclusion Criteria:
- Parent not English or Spanish-speaking
Provider study:
Inclusion Criteria:
- Health providers who care for children with asthma
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: AAAAI Action Plan
Asthma Action Plan from the American Academy of Allergy, Asthma, and Immunology
|
|
|
Experimentell: Asthma pictogram written action plan
Cartoon/pictogram-based written action plan sheet
|
Asthma action plan using plain language, pictograms, and photographs
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Asthma Action Plan knowledge (parent)
Tidsram: 1 day (on same day of enrollment; no outcome assessment after day of enrollment)
|
Outcome measure will be assessed on the day of enrollment only, using a hypothetical scenario.
No outcome assessments will be performed after the day of enrollment.
|
1 day (on same day of enrollment; no outcome assessment after day of enrollment)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Asthma action plan content (provider)
Tidsram: same day as presentation of hypothetical counseling scenario
|
Provider coverage of green/yellow/red zone concepts, spacer use, medication information, symptoms; use of low literacy principles
|
same day as presentation of hypothetical counseling scenario
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Suzy Tomopoulos, MD, NYU School of Medicine
- Huvudutredare: Shonna (Hsiang) Yin, MD, NYU School of Medicine
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 09-0358
Läkemedels- och apparatinformation, studiedokument
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