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Asthma | Improving Parent Understanding of Instructions About Asthma Care

Asthma research study

What is the primary objective of this study?

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).

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Asthma

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:Pictogram-based asthma action planAsthma action plan using plain language, pictograms, and photographs

Other:AAAAI standard of care written action plan

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

AAAAI Action PlanAsthma Action Plan from the American Academy of Allergy, Asthma, and Immunology

Asthma pictogram written action planCartoon/pictogram-based written action plan sheet

Study Status

Completed

Start Date: July 2011

Completed Date: March 2018

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Asthma Action Plan knowledge (parent)

Secondary Outcome: Asthma action plan content (provider)

Study sponsors, principal investigator, and references

Principal Investigator: Suzy Tomopoulos, MD

Lead Sponsor: New York University School of Medicine

Collaborator: Feinberg School of Medicine, Northwestern University

More information:https://clinicaltrials.gov/show/NCT01405625

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