Evaluation of the Asthma Management Program to Promote Activity for Students in Schools (Asthma-PASS)

NCT04576442 | Completed DMC

• 2 other identifiers: 2019-10930R33HL147908
• Study Type: interventional
• Target: 452
• Locations: 1 country
• Sites: 1

Brief Summary

Physical activity (PA) is an important component of asthma management in children. Studies show that PA is associated with decreased severity of asthma symptoms, as well as improved disease control and quality of life. However, urban minority children with asthma face barriers to PA on multiple levels.The goal of this research project is to evaluate whether a multifaceted school-based intervention that addresses key barriers to physical activity reduces asthma morbidity among urban schoolchildren with asthma.

Conditions

Asthma in Children

Outcome Measures

Primary Outcomes (1)

• Change in the number of Symptom free days (SFDs)

  Change from baseline in the number of SFDs will be assessed. Caregivers will report the number of days their child experienced no symptoms of asthma (defined as 24 hours with no coughing, wheezing, chest tightness, or shortness of breath) over the prior 14 day period. Symptom diaries provided as part of the study will be used to assist with recall. The trial will be successful if the intervention demonstrates a significantly greater improvement over time on SFDs at any of the 4 post-baseline assessments.

  Baseline, 3, 6, 9, and 12 months

Secondary Outcomes (1)

• Physical activity

  Baseline, 3, 6 and 9 months

Other Outcomes (5)

• Pediatric Asthma Caregiver's Quality of Life

  3-12 months

• Childhood Asthma Control Test

  3-12 months

• Adherence

  3-12 months

Study Arms (2)

Asthma-PASS Intervention

EXPERIMENTAL

Collaboration with PCPs to optimize management. Community Health Worker (CHW) to ensure PCP plan is followed. Two asthma education sessions with children/caregivers focusing on self-efficacy and physical activity promotion. Promotion of asthma awareness in school. School personnel training in asthma

Behavioral: Asthma-PASS; Behavioral: Child/Caregiver Education session

Asthma Management Comparison Group

ACTIVE COMPARATOR

Includes two sessions of basic asthma education and PCP notification of child's asthma severity level.

Behavioral: Basic Asthma Management (AM); Behavioral: Child/Caregiver Education session

Interventions

Child/Caregiver Education session BEHAVIORAL

The investigator will provide in-school child asthma education sessions delivered by trained, bilingual (English-Spanish) Community Health Workers (CHWs) using an established manualized protocol from past and current studies designed to improve knowledge and self-efficacy. Each child will receive two 1-on 1, 20-minute developmentally appropriate educational sessions at school 3-4 weeks apart. Sessions will cover: 1) asthma basics, symptoms and triggers; and 2) medications and correct administration technique. Caregivers will be called after each child session to highlight key points reviewed with the child and answer questions.

Asthma Management Comparison Group; Asthma-PASS Intervention

Asthma-PASS BEHAVIORAL

The investigator will collaborate with the student's primary care provider (PCP) by sending a letter via facsimile, and/or e-mail to ensure appropriate medications are prescribed or adjusted and rescue medications are available at school. Community Health Workers (CHWs) will follow up with PCPs as needed to provide reminders about prescriptions for controlled medications and to ensure a medication administration form (MAF) is provided to schools to allow rescue medication administration by nurses. CHWs will work with local pharmacies when possible to have prescribed medications delivered to schools and homes. For students without a PCP, families will be referred to one of Montefiore Medical Center's 20 practices throughout the Bronx. For students without medical insurance or who are unable to go to a Montefiore clinic, New York City Department of Education (NYC DOE) physicians who routinely attend NYC schools will provide medical care and prescribe appropriate medications.

Asthma-PASS Intervention

Basic Asthma Management (AM) BEHAVIORAL

PCPs and caregivers will be notified that children in the AM group have persistent/uncontrolled asthma that warrants use of guideline-based preventative medications.

Asthma Management Comparison Group

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Physician-diagnosed asthma (based on parent report with validation from the child's physician)
• Intermittent asthma (but with a report of asthma symptoms, such as coughing, wheezing, chest tightness, mucus/phlegm or shortness of breath, in the past 12 months)
• Mild persistent or more severe asthma based on prescribed controller medication (currently well-controlled) but with a report of asthma symptoms (as specified above) within the past 12 months \[well-controlled due to taking controller medications in the past 12 months and without asthma symptoms (as specified above) within the past 12 months will qualify\]
• Mild persistent or more severe asthma, or asthma that is uncontrolled despite therapy (based on age-specific guidelines)
• Attending pre-kindergarten through 5th grade in NYC (primarily Bronx) schools and also schools in lower Hudson Valley
• Parent is able to speak and understand either English or Spanish
• Consent from the primary caregiver, caregiver permission for child participation as well as assent from the child (for age 7 and above)

You may not qualify if:

• No access to a phone to conduct follow-up surveys
• Family plans to leave the school or city in less than 6 months
• The child has other significant medical conditions, such as congenital heart disease, cystic fibrosis, or other chronic lung disease
• Child is unable to participate in routine physical education (PE) classes as per physician-completed sports participation form
• Children in foster care or other situations in which consent cannot be obtained from a guardian
• Child is a participant in a concurrent asthma intervention study

Sponsors & Collaborators

• University of Rochester: collaborator
• Columbia University: collaborator
• Montefiore Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Children's Hospital at Montefiore, Albert Einstein College of Medicine

The Bronx, New York, 10467, United States

Location

Study Officials

• Marina Reznik, MD, MS

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 6, 2020
• Study Start: February 9, 2021
• Primary Completion: August 27, 2025
• Study Completion: August 27, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)