Childhood Asthma Perception Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Childhood Asthma Perception Study

Conditions
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Asthma, Childhood Asthma

Intervention / Treatment
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* Behavioral: PEF Feedback
* Behavioral: Control Feedback


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEF Feedback<br>This group will have 9 visits across 15 months. | Behavioral: PEF Feedback<br>* Intervention group will receive PEF feedback and verbal feedback sessions across 3 feedback visits and asthma education.<br>|
| Active Comparator: Control Feedback<br>This group will have 9 visits across 15 months. | Behavioral: Control Feedback<br>* Control feedback group will receive feedback consisting of standardized messages and have 3 control feedback visits and asthma education.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Symptom Perception with Asthma Monitor (AM2) as percentage of guesses in the Under-Perception zone | The percentage of times a child under-perceives the severity of asthma symptoms | Change from Pre-intervention to 12-month-follow-up (15 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Illness Representation Scale (AIRS) | 37-item scale measuring risk factors for the underutilization of controller medications | Change from Pre-intervention to 12-month-follow-up (15 months) | 
| Asthma Management Self-Efficacy (ASE) scale: Parent and child versions | 13-item scale measures parent's confidence in their ability to help manage child's asthma | Change from Pre-intervention to 12-month-follow-up (15 months) | 
| Pediatric Asthma Quality of Life Questionnaire (PAQLQ) | 23-item self report questionnaire assessing child's overall functioning in relation to asthma | Change from Pre-intervention to 12-month-follow-up (15 months) | 
| Medication Adherence - percentage of total doses taken per day/prescribed per day | Self report of daily medication use, in relation to the prescribed use | Change from Pre-intervention to 12-month-follow-up (15 months) | 
| Health Care Use - Electronic Medical Record (EMR) review of asthma-related Emergency Department visits and hospitalizations | Quantity of asthma-related emergency visits throughout the duration of the study | Change from Pre-intervention to 12-month-follow-up (15 months) | 
| Asthma Control Test (C-ACT) | Self-report questionnaire for adolescents and parents | Change from Pre-intervention to 12-month-follow-up (15 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Childhood Asthma, Bronchial Diseases, Immune System Diseases, Lung Diseases, Lung Diseases, Obstructive, Respiratory Tract Diseases, Peak Flow Meter, Symptom Perception, Illness Representation