Improving Parent Understanding of Instructions About Asthma Care

NCT ID: NCT01405625

Last Updated: 2018-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 449 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2018-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

AAAAI Action Plan

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

Group Type: ACTIVE_COMPARATOR

AAAAI standard of care written action plan

Intervention Type: OTHER

Asthma pictogram written action plan

Cartoon/pictogram-based written action plan sheet

Group Type: EXPERIMENTAL

Pictogram-based asthma action plan

Intervention Type: OTHER

Asthma action plan using plain language, pictograms, and photographs

Interventions

Pictogram-based asthma action plan

Asthma action plan using plain language, pictograms, and photographs

Intervention Type: OTHER

AAAAI standard of care written action plan

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Health providers who care for children with asthma

Exclusion Criteria

• Parent not English or Spanish-speaking

Provider study:

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northwestern University Feinberg School of Medicine

OTHER

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suzy Tomopoulos, MD

Role: PRINCIPAL_INVESTIGATOR

NYU School of Medicine

Shonna (Hsiang) Yin, MD

Role: PRINCIPAL_INVESTIGATOR

NYU School of Medicine

Locations

NYU School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

09-0358

Identifier Type: -

Identifier Source: org_study_id