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Completed

NCT Number: NCT04576442

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.

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Key information

Conditions

Asthma in Children

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

The Bronx, New York, 10467, United States

About this study

Investigators will conduct a cluster-randomized controlled trial with eligible children with persistent or uncontrolled asthma from 60 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 4-8 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 Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. The RE-AIM framework is a public health tool used for planning and evaluating programs to improve translation from research into practice and ensure sustainability in real-world settings.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Physician-diagnosed asthma (based on parent report with validation from the child's physician)
  • Intermittent asthma (but with a report of asthma symptoms, such as coughing, wheezing, chest tightness, mucus/phlegm or shortness of breath, in the past 12 months)
  • Mild persistent or more severe asthma based on prescribed controller medication (currently well-controlled) but with a report of asthma symptoms (as specified above) within the past 12 months [well-controlled due to taking controller medications in the past 12 months and without asthma symptoms (as specified above) within the past 12 months will qualify]
  • Mild persistent or more severe asthma, or asthma that is uncontrolled despite therapy (based on age-specific guidelines)
  • Attending pre-kindergarten through 5th grade in NYC (primarily Bronx) schools and also schools in lower Hudson Valley
  • 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 physical education (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

Treatment and study plan

Asthma-PASS

Behavioral

The investigator will collaborate with the student's primary care provider (PCP) by sending a letter via facsimile, and/or e-mail 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 medication administration form (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, families will be referred 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, New York City Department of Education (NYC DOE) physicians who routinely attend NYC schools will provide medical care and prescribe appropriate medications.

Basic Asthma Management (AM)

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

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.

Primary outcomes

  1. Change in the number of Symptom free days (SFDs)

    Time frame: Baseline, 3, 6, 9, and 12 months

    Change from baseline in the number of SFDs will be assessed. Caregivers will report the number of days their child experienced no symptoms of asthma (defined as 24 hours with no coughing, wheezing, chest tightness, or shortness of breath) over the prior 14 day period. Symptom diaries provided as part of the study will be used to assist with recall. The trial will be successful if the intervention demonstrates a significantly greater improvement over time on SFDs at any of the 4 post-baseline assessments.

Secondary outcomes

  1. Physical activity

    Time frame: Baseline, 3, 6 and 9 months

    Physical activity will be assessed by the number of minutes the child engages in 'moderate-vigorous' physical activity based on measurements taken using the ActiGraph GT3X+ activity monitor, a small, tri-axial micro-electromechanical system (MEMS) based accelerometer. Measurements will be taken over 7 consecutive days at baseline, 3, 6 and 9 months using the activity monitor. Children will wear the monitor on their waist, secured using an elastic belt. The number of minutes the child is in 'moderate-vigorous' physical activity will be summarized by study arm.

Other outcomes

  1. Pediatric Asthma Caregiver's Quality of Life

    Time frame: 3-12 months

    Validated caregiver asthma related quality of life survey; 13 items, 7-point scale (ranging from 1-7); higher score indicates less impairment

  2. Childhood Asthma Control Test

    Time frame: 3-12 months

    asthma control based on symptom frequency; score 0-27; higher score indicates well controlled asthma; score 19 or less indicates uncontrolled asthma.

  3. Adherence

    Time frame: 3-12 months

    controller medication adherence, score range 0-4; higher scores corresponding to recommended behavior.

  4. Asthma self-management questionnaire

    Time frame: 3-12 months

    caregiver self-management behavior; score range 0-100; higher score indicates more knowledge of self-management

  5. Asthma knowledge

    Time frame: 3-12 months

    Caregiver asthma knowledge using sub-scale of Asthma Illness Representation Scale; score range 1-5; higher score represent better knowledge.

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Collaborators

  • Columbia University
  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of Rochester

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Oct 6, 2020
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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