Childhood Asthma Perception Study

Asthma Clinical Trial

— CAPS  

Official title:

Childhood Asthma Perception Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02702687
• Other study ID #: 2014-3257
• Secondary ID: 1R01HL128260-01
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: July 28, 2022

Study information

• Verified date: February 2023
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 363
• Est. completion date: July 28, 2022
• Est. primary completion date: July 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Asthma
• Childhood Asthma

Intervention

Behavioral:
• PEF Feedback
Intervention group will receive PEF feedback and verbal feedback sessions across 3 feedback visits and asthma education.
• Control Feedback
Control feedback group will receive feedback consisting of standardized messages and have 3 control feedback visits and asthma education.

Locations

Country	Name	City	State
United States	Jacobi Medical Center	Bronx	New York
United States	Montefiore Medical Center	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Asthma Control Test (C-ACT)	Self-report questionnaire for adolescents and parents	Change from Pre-intervention to 12-month-follow-up (15 months)