Improving Parent Understanding of Instructions About Asthma Care
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|ClinicalTrials.gov Identifier: NCT01405625|
Recruitment Status : Active, not recruiting
First Posted : July 29, 2011
Last Update Posted : December 14, 2017
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|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|
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
- 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.
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT01405625
|United States, New York|
|NYU School of Medicine|
|New York, New York, United States, 10016|
|Principal Investigator:||Suzy Tomopoulos, MD||NYU School of Medicine|
|Principal Investigator:||Shonna (Hsiang) Yin, MD||NYU School of Medicine|