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

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma in Children
• Intervention / Treatment: Behavioral: Asthma-PASS; Behavioral: Child/Caregiver Education session; Behavioral: Basic Asthma Management (AM)

Detailed Description

Investigators will conduct a cluster-randomized controlled trial with 416 children ages 5-11 years with persistent or uncontrolled asthma from 26 Bronx schools. Schools will be randomly assigned to either (1) the Asthma-PASS intervention or an asthma management (AM) comparison group. Both groups will participate in an existing classroom-based daily activity program. Enrollment will occur over 4 consecutive school years with 6-8 schools joining the study each year. The investigators will assess the effectiveness of Asthma-PASS in reducing asthma morbidity, and improving PA as well as additional clinical and functional outcomes. The investigators will also identify potential mediators and moderators of the intervention effect. They will evaluate the process of intervention implementation by applying the RE-AIM framework.

• Study Type: Interventional
• Enrollment (Estimated): 416
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marina Reznik, MD, MS; Phone Number: 7187412494; Email: mreznik@montefiore.org

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Recruiting
      • Children's Hospital at Montefiore, Albert Einstein College of Medicine
      • Contact: Marina Reznik, MD, MS; Phone Number: 718-741-2494; Email: mreznik@montefiore.org
      • Principal Investigator: Marina Reznik, MD, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 11 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Physician-diagnosed asthma (based on parent report with validation from the child's physician).
• Mild persistent or more severe asthma, or asthma that is uncontrolled despite therapy
• Attending kindergarten through 5th grade in Bronx elementary schools
• 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).

Exclusion Criteria:

• 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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Asthma-PASS Intervention; 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; The investigator will collaborate with the student's primary care provider (PCP) by sending a letter via facsimile, and/or email 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 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, we will refer families 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, the NYC DOE physicians who routinely attend NYC schools will provide medical care and prescribe appropriate medications.; Behavioral: Child/Caregiver Education session; 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.
Active Comparator: Asthma Management Comparison Group; Includes two sessions of basic asthma education and PCP notification of child's asthma severity level.	Behavioral: Child/Caregiver Education session; 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.; Behavioral: Basic Asthma Management (AM); PCPs and caregivers will be notified that children in the AM group have persistent/uncontrolled asthma that warrants use of guideline-based preventative medications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom free days	number of days without symptoms in the past 14 days	3-12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity	minutes in moderate-vigorous physical activity	3-9 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pediatric Asthma Caregiver's Quality of Life	Validated caregiver asthma related quality of life survey; 13 items, 7-point scale (ranging from 1-7); higher score indicates less impairment	3-12 months
Childhood Asthma Control Test	asthma control based on symptom frequency; score 0-27; higher score indicates well controlled asthma; score 19 or less indicates uncontrolled asthma.	3-12 months
Adherence	controller medication adherence, score range 0-4; higher scores corresponding to recommended behavior.	3-12 months
Asthma self-management questionnaire	caregiver self-management behavior; score range 0-100; higher score indicates more knowledge of self-management	3-12 months
Asthma knowledge	Caregiver asthma knowledge using sub-scale of Asthma Illness Representation Scale; score range 1-5; higher score represent better knowledge.	3-12 months

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Columbia University; University of Rochester
• Investigators: Principal Investigator: Marina Reznik, MD, MS, Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2021
• Primary Completion (Estimated): September 25, 2025
• Study Completion (Estimated): September 25, 2025

Study Registration Dates

• First Submitted: September 29, 2020
• First Submitted That Met QC Criteria: October 5, 2020
• First Posted (Actual): October 6, 2020

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• 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: 2019-10930; R33HL147908 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No