Clinical trial NCT02702687: Childhood Asthma Perception Study
Official title: Childhood Asthma Perception Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Childhood Asthma
Keywords: Asthma
Childhood Asthma
Bronchial Diseases
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases
Peak Flow Meter
Symptom Perception
Illness Representation
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2016-03-09
Enrollment: 363
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Asthma Symptom Perception with Asthma Monitor (AM2) as percentage of guesses in the Under-Perception zone
timeFrame: Change from Pre-intervention to 12-month-follow-up (15 months)
Secondary outcomes:
measure: Asthma Illness Representation Scale (AIRS)
timeFrame: Change from Pre-intervention to 12-month-follow-up (15 months)
measure: Asthma Management Self-Efficacy (ASE) scale: Parent and child versions
timeFrame: Change from Pre-intervention to 12-month-follow-up (15 months)
measure: Pediatric Asthma Quality of Life Questionnaire (PAQLQ)
timeFrame: Change from Pre-intervention to 12-month-follow-up (15 months)
measure: Medication Adherence - percentage of total doses taken per day/prescribed per day
timeFrame: Change from Pre-intervention to 12-month-follow-up (15 months)
measure: Health Care Use - Electronic Medical Record (EMR) review of asthma-related Emergency Department visits and hospitalizations
timeFrame: Change from Pre-intervention to 12-month-follow-up (15 months)
measure: Asthma Control Test (C-ACT)
timeFrame: Change from Pre-intervention to 12-month-follow-up (15 months)
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Jonathan Feldman, PhD
role: PRINCIPAL_INVESTIGATOR
References: