Improving Parent Understanding of Instructions About Asthma Care
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Asthma |
Other: Pictogram-based asthma action plan |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Health Services Research |
| Official Title: | Improving Parent Understanding of Instructions About Asthma Care |
- Asthma Action Plan knowledge (parent) [ Time Frame: 1 day (on same day of enrollment; no outcome assessment after day of enrollment) ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Provider coverage of green/yellow/red zone concepts, spacer use, medication information, symptoms; use of low literacy principles
| Estimated Enrollment: | 350 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: AAAAI Action Plan
Asthma Action Plan from the American Academy of Allergy, Asthma, and Immunology
|
Other: Pictogram-based asthma action plan
Asthma action plan using plain language, pictograms, and photographs
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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| Contact: Suzy Tomopoulos, MD | 212-562-6042 | Soultana.Tomopoulos@nyumc.org |
| Contact: Shonna (Hsiang) Yin, MD | 212-562-2821 | yinh02@med.nyu.edu |
| United States, New York | |
| NYU School of Medicine | Recruiting |
| New York City, New York, United States, 10016 | |
| Contact: Suzy Tomopoulos, MD 212-562-6042 Soultana.Tomopoulos@nyumc.org | |
| Contact: Shonna (Hsiang) Yin, MD 1 212 562 2821 yinh02@med.nyu.edu | |
| Sub-Investigator: Benard Dreyer, MD | |
| Sub-Investigator: Alan L Mendelsohn, MD | |
| Sub-Investigator: Arthur Fierman, MD | |
| Principal Investigator: | Suzy Tomopoulos, MD | NYU School of Medicine |
| Principal Investigator: | Shonna (Hsiang) Yin, MD | NYU School of Medicine |
More Information
No publications provided
| Responsible Party: | New York University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01405625 History of Changes |
| Other Study ID Numbers: | 09-0358 |
| Study First Received: | July 26, 2011 |
| Last Updated: | January 15, 2013 |
| Health Authority: | United States: Institutional Review Board |
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 |
ClinicalTrials.gov processed this record on May 21, 2013