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

Asthma in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04576442
• Other study ID #: 2019-10930
• Secondary ID: R33HL147908
• Status: Recruiting
• Phase: N/A
• Start date: February 9, 2021
• Est. completion date: September 25, 2025

Study information

• Verified date: September 2023
• Source: Montefiore Medical Center
• Contact: Marina Reznik, MD, MS
• Phone: 7187412494
• Email: mreznik[@]montefiore.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 416
• Est. completion date: September 25, 2025
• Est. primary completion date: September 25, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Children's Hospital at Montefiore, Albert Einstein College of Medicine	Bronx	New York

Sponsors (4)

Lead Sponsor	Collaborator
Montefiore Medical Center	Columbia University, National Heart, Lung, and Blood Institute (NHLBI), University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Adherence	controller medication adherence, score range 0-4; higher scores corresponding to recommended behavior.	3-12 months
Other	Asthma self-management questionnaire	caregiver self-management behavior; score range 0-100; higher score indicates more knowledge of self-management	3-12 months
Other	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
Primary	Symptom free days	number of days without symptoms in the past 14 days	3-12 months
Secondary	Physical activity	minutes in moderate-vigorous physical activity	3-9 months