Childhood Asthma Perception Study (CAPS)

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.

Study Overview

• Status: Completed
• Conditions: Asthma; Childhood Asthma
• Intervention / Treatment: Behavioral: PEF Feedback; Behavioral: Control Feedback

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.

• Study Type: Interventional
• Enrollment (Actual): 363
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center
    • Bronx, New York, United States, 10461
      • Jacobi Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Albert Einstein College of Medicine
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Jonathan Feldman, PhD, Albert Einstein College of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2016
• Primary Completion (ACTUAL): July 28, 2022
• Study Completion (ACTUAL): July 28, 2022

Study Registration Dates

• First Submitted: February 25, 2016
• First Submitted That Met QC Criteria: March 3, 2016
• First Posted (ESTIMATE): March 9, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Immune System Diseases; Childhood Asthma; Lung Diseases; Peak Flow Meter; Symptom Perception; Illness Representation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 2014-3257; 1R01HL128260-01 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO