Improving Parent Understanding of Instructions About Asthma Care

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	500 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
Estimated Primary Completion Date :	March 2018
Estimated Study Completion Date :	August 2018

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, New York
NYU School of Medicine
New York, New York, United States, 10016

Sponsors and Collaborators

New York University School of Medicine

Feinberg School of Medicine, Northwestern University

Investigators

Principal Investigator:	Suzy Tomopoulos, MD	NYU School of Medicine
Principal Investigator:	Shonna (Hsiang) Yin, MD	NYU School of Medicine

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	New York University School of Medicine
ClinicalTrials.gov Identifier:	NCT01405625 History of Changes
Other Study ID Numbers:	09-0358
First Posted:	July 29, 2011
Last Update Posted:	December 14, 2017
Last Verified:	December 2017

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by New York University School of Medicine:

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

Additional relevant MeSH terms:

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases	Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases