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

Last updated: October 21, 2024
Sponsor: Montefiore Medical Center
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Asthma

Treatment

Child/Caregiver Education session

Basic Asthma Management (AM)

Asthma-PASS

Clinical Study ID

NCT04576442
2019-10930
R33HL147908
  • Ages 5-11
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Physician-diagnosed asthma (based on parent report with validation from the child'sphysician).

  • Mild persistent or more severe asthma, or asthma that is uncontrolled despitetherapy

  • 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 aswell as assent from the child (for age 7 and above).

Exclusion

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 heartdisease, cystic fibrosis, or other chronic lung disease.

  • Child is unable to participate in routine PE classes as per physician-completedsports participation form.

  • Children in foster care or other situations in which consent cannot be obtained froma guardian.

  • Child is a participant in a concurrent asthma intervention study.

Study Design

Total Participants: 452
Treatment Group(s): 3
Primary Treatment: Child/Caregiver Education session
Phase:
Study Start date:
February 09, 2021
Estimated Completion Date:
September 30, 2025

Study 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.

Connect with a study center

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

    Bronx, New York 10467
    United States

    Site Not Available

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