Improving Parent Understanding of Instructions About Asthma Care

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Other: AAAAI standard of care written action plan; Other: Pictogram-based asthma action plan

• Registration Number: NCT01405625
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-26
• Study First Submitted QC: 2011-07-28
• Study First Posted: 2011-07-29
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-04
• Last Update Posted: 2018-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 449

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AAAAI Action Plan	AAAAI standard of care written action plan	Asthma Action Plan from the American Academy of Allergy, Asthma, and Immunology
Asthma pictogram written action plan	Pictogram-based asthma action plan	Cartoon/pictogram-based written action plan sheet

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Asthma action plan content (provider)	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

Trial Locations

Locations (1)

NYU School of Medicine; 🇺🇸 New York, New York, United States