Clinical trial NCT04576442: Evaluation of the Asthma Management Program to Promote Activity for Students in Schools (Asthma-PASS)
Official title: Evaluation of the Asthma Management Program to Promote Activity for Students in Schools (Asthma-PASS)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Asthma in Children
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: University of Rochester
name: Columbia University
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-10-06
Enrollment: 452
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change in the number of Symptom free days (SFDs)
timeFrame: Baseline, 3, 6, 9, and 12 months
Secondary outcomes:
measure: Physical activity
timeFrame: Baseline, 3, 6 and 9 months
Other outcomes:
measure: Pediatric Asthma Caregiver's Quality of Life
timeFrame: 3-12 months
measure: Childhood Asthma Control Test
timeFrame: 3-12 months
measure: Adherence
timeFrame: 3-12 months
measure: Asthma self-management questionnaire
timeFrame: 3-12 months
measure: Asthma knowledge
timeFrame: 3-12 months
Locations:
city: Bronx
country: United States
facility: Children's Hospital at Montefiore, Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Marina Reznik, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: