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

Montefiore Medicine Academic Health System

Status: Active, not recruiting

Conditions: Asthma in Children

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04576442

R33HL147908 (U.S. NIH Grant/Contract)

2019-10930

Details and patient eligibility

About

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.

Full 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.

Enrollment: 452 patients

Sex: All

Ages: 5 to 11 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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452 participants in 2 patient groups

Asthma-PASS Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Asthma-PASS

Behavioral: Child/Caregiver Education session

Asthma Management Comparison Group

Active Comparator group

Description:

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

Treatment:

Behavioral: Child/Caregiver Education session

Behavioral: Basic Asthma Management (AM)