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

NCT ID: NCT04576442

Last Updated: 2024-10-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 452 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-09
• Study Completion Date: 2025-09-30

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.

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.

Conditions

Asthma in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Asthma-PASS

Intervention Type: BEHAVIORAL

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.

Child/Caregiver Education session

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Basic Asthma Management (AM)

Intervention Type: 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.

Child/Caregiver Education session

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marina Reznik, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

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

The Bronx, New York, United States

Countries

United States

Other Identifiers

R33HL147908

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2019-10930

Identifier Type: -

Identifier Source: org_study_id