Childhood Asthma Perception Study

NCT ID: NCT02702687

Last Updated: 2023-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 363 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2022-07-28

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.

Conditions

Asthma; Childhood Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

PEF Feedback

This group will have 9 visits across 15 months.

Group Type: EXPERIMENTAL

PEF Feedback

Intervention Type: BEHAVIORAL

Intervention group will receive PEF feedback and verbal feedback sessions across 3 feedback visits and asthma education.

Control Feedback

This group will have 9 visits across 15 months.

Group Type: ACTIVE_COMPARATOR

Control Feedback

Intervention Type: BEHAVIORAL

Control feedback group will receive feedback consisting of standardized messages and have 3 control feedback visits and asthma education.

Interventions

PEF Feedback

Intervention group will receive PEF feedback and verbal feedback sessions across 3 feedback visits and asthma education.

Intervention Type: BEHAVIORAL

Control Feedback

Control feedback group will receive feedback consisting of standardized messages and have 3 control feedback visits and asthma education.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan Feldman, PhD

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Locations

Jacobi Medical Center

The Bronx, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39454196 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01HL128260-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2014-3257

Identifier Type: -

Identifier Source: org_study_id