Purpose

This randomized controlled trial will include Latino and Black adolescents with asthma ages 10-17 years old and their caregivers. Participants will be recruited from clinics in the Bronx, New York. The primary aims are to examine the efficacy of peak expiratory flow (PEF) prediction with feedback versus control feedback on 1) under-perception of asthma symptoms 2) controller medication adherence and 3) asthma control and emergency health care use. These aims will be examined across a 1-year follow-up. An exploratory aim examines the hypothesized pathway that the PEF intervention reduces under-perception of symptoms, shifts illness representations toward the professional model and increases adolescents' and parents' asthma management self-efficacy, resulting in greater medication adherence and improved asthma control.

Conditions

Eligibility

Eligible Ages
Between 10 Years and 17 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 10-17 years of age - Diagnosis of asthma (in medical record) - Report of breathing problems within the past 12 months - Prescribed a controller medication for asthma - At least one parent self-identifies as Latino or Black - The participating parent has primary or at least equal responsibility for the adolescent

Exclusion Criteria

  • Cognitive learning disability (parent report) - No prescription for asthma controller medication - Inability to perform acceptable PEF blows - Race/ethnicity other than Latino or Black - Other significant pulmonary conditions (cystic fibrosis)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
PEF Feedback
This group will have 9 visits across 15 months.
  • Behavioral: PEF Feedback
    Intervention group will receive PEF feedback and verbal feedback sessions across 3 feedback visits and asthma education.
Active Comparator
Control Feedback
This group will have 9 visits across 15 months.
  • Behavioral: Control Feedback
    Control feedback group will receive feedback consisting of standardized messages and have 3 control feedback visits and asthma education.

More Details

Status
Completed
Sponsor
Albert Einstein College of Medicine

Study Contact

Detailed Description

Under-perception of asthma symptoms in children is a major risk factor for emergency department visits, hospitalizations, and near-fatal/fatal asthma attacks. Puerto Rican and Black children have greater asthma morbidity and mortality rates than all other racial/ethnic groups. Interventions targeting asthma symptom perception and medication adherence may help close this asthma health disparities gap. The baseline visit for all families consists of standardized asthma education followed by 3 weeks of PEF prediction without feedback using a programmable, electronic spirometer. Participants then will be randomized to intervention group or control feedback group and receive a brief feedback session. For the next 6 weeks, all adolescents will predict their PEF, which will be locked in before blowing into the device. Families will return at mid-intervention and post-intervention to receive feedback sessions. All adolescents will play an interactive asthma educational game to reinforce the baseline asthma education. At the post-intervention visit, the spirometer will be reprogrammed for the next 4 weeks. These symptom perception data will be downloaded at 1-month post-intervention. Controller medication adherence will be monitored by electronic devices. Post-intervention sessions will take place at 3, 6, 9, and 12 months to collect adherence data and conduct spirometry. Physicians will be blinded to group assignment and rate asthma severity using national guidelines. A 12-month retrospective medical record abstraction will compare emergency health care use for asthma between groups.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.