Childhood Asthma Perception Study
CAPS
2 other identifiers
interventional
363
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable asthma
Started May 2016
Longer than P75 for not_applicable asthma
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2016
CompletedFirst Posted
Study publicly available on registry
March 9, 2016
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 28, 2022
CompletedFebruary 6, 2023
February 1, 2023
6.2 years
February 25, 2016
February 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Asthma Illness Representation Scale (AIRS)
Change from Pre-intervention to 12-month-follow-up (15 months)
Asthma Management Self-Efficacy (ASE) scale: Parent and child versions
Change from Pre-intervention to 12-month-follow-up (15 months)
Pediatric Asthma Quality of Life Questionnaire (PAQLQ)
Change from Pre-intervention to 12-month-follow-up (15 months)
Medication Adherence - percentage of total doses taken per day/prescribed per day
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
Change from Pre-intervention to 12-month-follow-up (15 months)
- +1 more secondary outcomes
Study Arms (2)
PEF Feedback
EXPERIMENTALThis group will have 9 visits across 15 months.
Control Feedback
ACTIVE COMPARATORThis group will have 9 visits across 15 months.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Jacobi Medical Center
The Bronx, New York, 10461, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Related Publications (1)
Feldman JM, Rastogi D, Warman K, Serebrisky D, Arcoleo K. Peak Flow Feedback Intervention Improves Underperception of Airflow Limitation in Pediatric Asthma: A Randomized Clinical Trial. Ann Am Thorac Soc. 2025 Mar;22(3):403-415. doi: 10.1513/AnnalsATS.202406-637OC.
PMID: 39454196DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan Feldman, PhD
Albert Einstein College of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2016
First Posted
March 9, 2016
Study Start
May 1, 2016
Primary Completion
July 28, 2022
Study Completion
July 28, 2022
Last Updated
February 6, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share