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

Not Applicable

Active, not recruiting

• Conditions: Asthma in Children
• Interventions: Behavioral: Asthma-PASS; Behavioral: Basic Asthma Management (AM); Behavioral: Child/Caregiver Education session

• Registration Number: NCT04576442
• Lead Sponsor: Montefiore Medical Center

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.

Study Timeline

• Study First Submitted: 2020-09-29
• Study First Submitted QC: 2020-10-05
• Study First Posted: 2020-10-06
• Study Start: 2021-02-09
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-23
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 452

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Asthma-PASS Intervention	Asthma-PASS	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
Asthma Management Comparison Group	Basic Asthma Management (AM)	Includes two sessions of basic asthma education and PCP notification of child's asthma severity level.
Asthma-PASS Intervention	Child/Caregiver Education session	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
Asthma Management Comparison Group	Child/Caregiver Education session	Includes two sessions of basic asthma education and PCP notification of child's asthma severity level.

Primary Outcome Measures

Name	Time	Method
Change in the number of Symptom free days (SFDs)	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 Outcome Measures

Name	Time	Method
Physical activity	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.

Trial Locations

Locations (1)

Children's Hospital at Montefiore, Albert Einstein College of Medicine; 🇺🇸 Bronx, New York, United States