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Improving Parent Understanding of Instructions About Asthma Care

Improving Parent Understanding of Instructions About Asthma Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01405625
Enrollment
449
Registered
2011-07-29
Start date
2011-07-31
Completion date
2018-03-31
Last updated
2018-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, Health literacy, Parent knowledge of appropriate action plan steps

Brief summary

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).

Interventions

OTHERPictogram-based asthma action plan

Asthma action plan using plain language, pictograms, and photographs

OTHERAAAAI standard of care written action plan

Sponsors

Northwestern University Feinberg School of Medicine
CollaboratorOTHER
NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Asthma Action Plan knowledge (parent)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.

Secondary

MeasureTime frameDescription
Asthma action plan content (provider)same day as presentation of hypothetical counseling scenarioProvider coverage of green/yellow/red zone concepts, spacer use, medication information, symptoms; use of low literacy principles

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026