Improving Parent Understanding of Instructions About Asthma Care

NCT01405625 | Completed DMC

• 1 other identifier: 09-0358
• Study Type: interventional
• Target: 449
• Locations: 1 country
• Sites: 1

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).

Conditions

Asthma

Keywords

Asthma; Health literacy; Parent knowledge of appropriate action plan steps

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Asthma action plan content (provider)

  same day as presentation of hypothetical counseling scenario

Study Arms (2)

AAAAI Action Plan

ACTIVE COMPARATOR

Asthma Action Plan from the American Academy of Allergy, Asthma, and Immunology

Other: AAAAI standard of care written action plan

Asthma pictogram written action plan

EXPERIMENTAL

Cartoon/pictogram-based written action plan sheet

Other: Pictogram-based asthma action plan

Interventions

Pictogram-based asthma action plan OTHER

Asthma action plan using plain language, pictograms, and photographs

Asthma pictogram written action plan

AAAAI standard of care written action plan OTHER

AAAAI Action Plan

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary caregiver / parent / legal guardian of child 2-12 years old
• Child with diagnosis of asthma

You may not qualify if:

• Parent not English or Spanish-speaking
• Provider study:
• Health providers who care for children with asthma

Sponsors & Collaborators

• NYU Langone Health: lead
• Northwestern University Feinberg School of Medicine: collaborator

Study Sites (1)

NYU School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Suzy Tomopoulos, MD

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

• Shonna (Hsiang) Yin, MD

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2011
• First Posted: July 29, 2011
• Study Start: July 1, 2011
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: October 5, 2018

Record last verified: 2018-10

Locations

US (1)