Childhood Asthma Perception Study
Condition: Asthma; Childhood Asthma
MeSH terms: Asthma
Study type: Interventional

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.
    

Intervention name(s): PEF Feedback; Control Feedback
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Intervention group will receive PEF feedback and verbal feedback sessions across 3 feedback visits and asthma education.; Control feedback group will receive feedback consisting of standardized messages and have 3 control feedback visits and asthma education.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Childhood Asthma; Bronchial Diseases; Immune System Diseases; Lung Diseases; Lung Diseases, Obstructive; Respiratory Tract Diseases; Peak Flow Meter; Symptom Perception; Illness Representation