Clinical trial NCT01405625: Improving Parent Understanding of Instructions About Asthma Care
Official title: Improving Parent Understanding of Instructions About Asthma Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Health literacy
Parent knowledge of appropriate action plan steps
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Northwestern University Feinberg School of Medicine
First posted: 2011-07-29
Enrollment: 449
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).


Eligibility 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

Primary outcomes:
measure: Asthma Action Plan knowledge (parent)
timeFrame: 1 day (on same day of enrollment; no outcome assessment after day of enrollment)
Secondary outcomes:
measure: Asthma action plan content (provider)
timeFrame: same day as presentation of hypothetical counseling scenario
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU School of Medicine
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Suzy Tomopoulos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU School of Medicine
name: Shonna (Hsiang) Yin, MD
role: PRINCIPAL_INVESTIGATOR
References: