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| ID | Type | Description | Link |
|---|---|---|---|
| R33HL147908 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Rochester | OTHER |
| Columbia University | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asthma-PASS Intervention | Experimental | 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 |
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| Asthma Management Comparison Group | Active Comparator | Includes two sessions of basic asthma education and PCP notification of child's asthma severity level. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the number of Symptom free days (SFDs) | 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. | Baseline, 3, 6, 9, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Physical activity | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pediatric Asthma Caregiver's Quality of Life | Validated caregiver asthma related quality of life survey; 13 items, 7-point scale (ranging from 1-7); higher score indicates less impairment | 3-12 months |
| Childhood Asthma Control Test |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marina Reznik, MD, MS | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital at Montefiore, Albert Einstein College of Medicine | The Bronx | New York | 10467 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 8, 2025 | Apr 7, 2026 | ICF_000.pdf |
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| 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. |
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| 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. |
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| Baseline, 3, 6 and 9 months |
asthma control based on symptom frequency; score 0-27; higher score indicates well controlled asthma; score 19 or less indicates uncontrolled asthma.
| 3-12 months |
| Adherence | controller medication adherence, score range 0-4; higher scores corresponding to recommended behavior. | 3-12 months |
| Asthma self-management questionnaire | caregiver self-management behavior; score range 0-100; higher score indicates more knowledge of self-management | 3-12 months |
| Asthma knowledge | Caregiver asthma knowledge using sub-scale of Asthma Illness Representation Scale; score range 1-5; higher score represent better knowledge. | 3-12 months |