Improving Parent Understanding of Instructions About Asthma Care
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pictogram-based asthma action plan
AAAAI standard of care written action plan
Sponsored by
About this trial
This is an interventional health services research trial for Asthma focused on measuring Asthma, Health literacy, Parent knowledge of appropriate action plan steps
Eligibility 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
Sites / Locations
- NYU School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
AAAAI Action Plan
Asthma pictogram written action plan
Arm Description
Asthma Action Plan from the American Academy of Allergy, Asthma, and Immunology
Cartoon/pictogram-based written action plan sheet
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Asthma action plan content (provider)
Provider coverage of green/yellow/red zone concepts, spacer use, medication information, symptoms; use of low literacy principles
Full Information
NCT ID
NCT01405625
First Posted
July 26, 2011
Last Updated
October 4, 2018
Sponsor
NYU Langone Health
Collaborators
Northwestern University Feinberg School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01405625
Brief Title
Improving Parent Understanding of Instructions About Asthma Care
Official Title
Improving Parent Understanding of Instructions About Asthma Care
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
July 2011 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Northwestern University Feinberg School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Health literacy, Parent knowledge of appropriate action plan steps
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
449 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AAAAI Action Plan
Arm Type
Active Comparator
Arm Description
Asthma Action Plan from the American Academy of Allergy, Asthma, and Immunology
Arm Title
Asthma pictogram written action plan
Arm Type
Experimental
Arm Description
Cartoon/pictogram-based written action plan sheet
Intervention Type
Other
Intervention Name(s)
Pictogram-based asthma action plan
Intervention Description
Asthma action plan using plain language, pictograms, and photographs
Intervention Type
Other
Intervention Name(s)
AAAAI standard of care written action plan
Primary Outcome Measure Information:
Title
Asthma Action Plan knowledge (parent)
Description
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.
Time Frame
1 day (on same day of enrollment; no outcome assessment after day of enrollment)
Secondary Outcome Measure Information:
Title
Asthma action plan content (provider)
Description
Provider coverage of green/yellow/red zone concepts, spacer use, medication information, symptoms; use of low literacy principles
Time Frame
same day as presentation of hypothetical counseling scenario
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzy Tomopoulos, MD
Organizational Affiliation
NYU School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shonna (Hsiang) Yin, MD
Organizational Affiliation
NYU School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
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Improving Parent Understanding of Instructions About Asthma Care
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