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

Primary Purpose

Asthma in Children

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Asthma-PASS

Basic Asthma Management (AM)

Child/Caregiver Education session

About this trial

This is an interventional supportive care trial for Asthma in Children

Eligibility Criteria

5 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Asthma-PASS Intervention

Asthma Management Comparison Group

Arm Description

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

Includes two sessions of basic asthma education and PCP notification of child's asthma severity level.

Outcomes

Primary Outcome Measures

Symptom free days

number of days without symptoms in the past 14 days

Secondary Outcome Measures

Physical activity

minutes in moderate-vigorous physical activity

Full Information

NCT ID

NCT04576442

First Posted

September 29, 2020

Last Updated

September 26, 2023

Sponsor

Montefiore Medical Center

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04576442

Brief Title

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

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 9, 2021 (Actual)

Primary Completion Date

September 25, 2025 (Anticipated)

Study Completion Date

September 25, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Montefiore Medical Center

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma in Children

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

416 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Asthma-PASS Intervention

Arm Type

Experimental

Arm Description

Arm Title

Asthma Management Comparison Group

Arm Type

Active Comparator

Arm Description

Includes two sessions of basic asthma education and PCP notification of child's asthma severity level.

Intervention Type

Behavioral

Intervention Name(s)

Asthma-PASS

Intervention Description

The investigator will collaborate with the student's primary care provider (PCP) by sending a letter via facsimile, and/or email 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 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, we will refer families 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, the NYC DOE physicians who routinely attend NYC schools will provide medical care and prescribe appropriate medications.

Intervention Type

Behavioral

Intervention Name(s)

Basic Asthma Management (AM)

Intervention Description

PCPs and caregivers will be notified that children in the AM group have persistent/uncontrolled asthma that warrants use of guideline-based preventative medications.

Intervention Type

Behavioral

Intervention Name(s)

Child/Caregiver Education session

Intervention Description

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 Outcome Measure Information:

Title

Symptom free days

Description

number of days without symptoms in the past 14 days

Time Frame

3-12 months

Secondary Outcome Measure Information:

Title

Physical activity

Description

minutes in moderate-vigorous physical activity

Time Frame

3-9 months

Other Pre-specified Outcome Measures:

Title

Pediatric Asthma Caregiver's Quality of Life

Description

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

Time Frame

3-12 months

Title

Childhood Asthma Control Test

Description

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

Time Frame

3-12 months

Title

Adherence

Description

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

Time Frame

3-12 months

Title

Asthma self-management questionnaire

Description

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

Time Frame

3-12 months

Title

Asthma knowledge

Description

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

Time Frame

3-12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

11 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marina Reznik, MD, MS

Phone

7187412494

mreznik@montefiore.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marina Reznik, MD, MS

Organizational Affiliation

Montefiore Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Bronx

State/Province

New York

ZIP/Postal Code

10467

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marina Reznik, MD, MS

Phone

718-741-2494

mreznik@montefiore.org

First Name & Middle Initial & Last Name & Degree

Marina Reznik, MD, MS

12. IPD Sharing Statement

Plan to Share IPD

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

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