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OpenTrials
Completed

NCT Number: 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).

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pictogram-based asthma action plan

Other

Asthma action plan using plain language, pictograms, and photographs

AAAAI standard of care written action plan

Other

Primary outcomes

  1. Asthma Action Plan knowledge (parent)

    Time frame: 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 outcomes

  1. Asthma action plan content (provider)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Northwestern University

Registry information

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Jul 29, 2011
Registry last updated
Oct 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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