NCT02702687

Childhood Asthma Perception Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 363 (actual)
• Sponsor: Albert Einstein College of Medicine · Academic / Other
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Asthma
• Childhood Asthma

Interventions

Type	Name	Description
BEHAVIORAL	PEF Feedback	Intervention group will receive PEF feedback and verbal feedback sessions across 3 feedback visits and asthma education.
BEHAVIORAL	Control Feedback	Control feedback group will receive feedback consisting of standardized messages and have 3 control feedback visits and asthma education.

Timeline

• Start date: 2016-05-01
• Primary completion: 2022-07-28
• Completion: 2022-07-28
• First posted: 2016-03-09
• Last updated: 2023-02-06

Locations

2 sites across 1 country: United States