Improving Parent Understanding of Instructions About Asthma Care

Asthma Clinical Trial

Official title:

Improving Parent Understanding of Instructions About Asthma Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01405625
• Other study ID #: 09-0358
• Status: Completed
• Phase: N/A
• Start date: July 2011
• Est. completion date: March 2018

Study information

• Verified date: October 2018
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 449
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• Pictogram-based asthma action plan
Asthma action plan using plain language, pictograms, and photographs
• AAAAI standard of care written action plan

Locations

Country	Name	City	State
United States	NYU School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	Feinberg School of Medicine, Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma Action Plan knowledge (parent)	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.	1 day (on same day of enrollment; no outcome assessment after day of enrollment)
Secondary	Asthma action plan content (provider)	Provider coverage of green/yellow/red zone concepts, spacer use, medication information, symptoms; use of low literacy principles	same day as presentation of hypothetical counseling scenario