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Improving Parent Understanding of Instructions About Asthma Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01405625
Recruitment Status : Completed
First Posted : July 29, 2011
Last Update Posted : October 5, 2018
Feinberg School of Medicine, Northwestern University
Information provided by (Responsible Party):
NYU Langone Health

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).

Condition or disease Intervention/treatment Phase
Asthma Other: Pictogram-based asthma action plan Other: AAAAI standard of care written action plan Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 449 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Improving Parent Understanding of Instructions About Asthma Care
Actual Study Start Date : July 2011
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Active Comparator: AAAAI Action Plan
Asthma Action Plan from the American Academy of Allergy, Asthma, and Immunology
Other: AAAAI standard of care written action plan
Experimental: Asthma pictogram written action plan
Cartoon/pictogram-based written action plan sheet
Other: Pictogram-based asthma action plan
Asthma action plan using plain language, pictograms, and photographs

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01405625

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United States, New York
NYU School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Feinberg School of Medicine, Northwestern University
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Principal Investigator: Suzy Tomopoulos, MD NYU School of Medicine
Principal Investigator: Shonna (Hsiang) Yin, MD NYU School of Medicine
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Responsible Party: NYU Langone Health Identifier: NCT01405625    
Other Study ID Numbers: 09-0358
First Posted: July 29, 2011    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NYU Langone Health:
Health literacy
Parent knowledge of appropriate action plan steps
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases