Improving Parent Understanding of Instructions About Asthma Care

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by New York University School of Medicine
Sponsor:
Collaborator:
Feinberg School of Medicine, Northwestern University
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01405625
First received: July 26, 2011
Last updated: February 13, 2014
Last verified: February 2014
  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

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 2015
Estimated Primary Completion Date: January 2015 (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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01405625

Contacts
Contact: Suzy Tomopoulos, MD 212-562-6042 Soultana.Tomopoulos@nyumc.org
Contact: Shonna (Hsiang) Yin, MD 212-562-2821 yinh02@med.nyu.edu

Locations
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         
Sponsors and Collaborators
New York University School of Medicine
Feinberg School of Medicine, Northwestern University
Investigators
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: February 13, 2014
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 August 19, 2014