CompletedNot Applicable

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

United States452 participantsStarted 2021-02-09

Plain-language 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.

Who can participate

Age range

4 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 * Ch…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in the number of Symptom free days (SFDs)

Timeframe: Baseline, 3, 6, 9, and 12 months

Trial details

NCT IDNCT04576442

SponsorMontefiore Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-27

View on ClinicalTrials.gov More Asthma in Children trials