Project ASTHMA - Aligning With Schools To Help Manage Asthma and Improve Outcomes

Официальное название

Project ASTHMA - Aligning With Schools To Help Manage Asthma and Decrease Health Inequities

Обзор

Children with asthma from communities that experience health inequities frequently do not receive guideline-based asthma care, and as a result, account for a disproportionate percentage of asthma exacerbations, emergency department visits, and hospitalizations. Project ASTHMA (Aligning with Schools To Help Manage Asthma) tests the effectiveness of school-based health centers as a delivery model to improve health outcomes by providing children with guideline-based asthma assessments and preventive medication management, directly observed therapy of their preventive medication to support adherence, and self-management support. If successful, this multicomponent intervention will represent a cost effective and sustainable model to reduce asthma morbidity in historically marginalized communities, and has the potential to impact communities throughout the United States where over 2,500 school-based health centers operate.

Вмешательства

• Другое APP assessment and management of asthma
  APPs will be trained to follow NIH guidelines for assessment and management of asthma, and to apply their knowledge to the care of the students. Students will also receive DOT of the morning dose of their controller medication.

Первичные конечные точки

• Asthma exacerbations [Срок оценки: from 1 month after enrollment to the end of the school year for 1 school year; to be assessed after the end of the school year.]

Вторичные конечные точки (10)

• Daytime asthma symptoms [Срок оценки: to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year]
• Nighttime asthma symptoms [Срок оценки: to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year]
• Spirometry - FEV1 [Срок оценки: to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year]
• Spirometry - FEV1/FVC ratio [Срок оценки: to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year]
• ED visits [Срок оценки: from 1 month after enrollment to the end of the school year for 1 school year; to be assessed after the end of the school year.]
• Urgent care visits [Срок оценки: from 1 month after enrollment to the end of the school year for 1 school year; to be assessed after the end of the school year.]
• Hospitalizations [Срок оценки: from 1 month after enrollment to the end of the school year; to be assessed after the end of the school year.]
• Quality of Life - caregiver [Срок оценки: to be assessed at baseline and at 7-month follow-up for 1 school year]
• Activity Limitation [Срок оценки: to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year]
• school absenteeism [Срок оценки: from 1 month after enrollment to the end of the school year for 1 school year; to be assessed after the end of the school year.]

Критерии участия

Критерии включения

• uncontrolled asthma

Критерии исключения

• other chronic lung disease such as cystic fibrosis

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• University at Buffalo, Department of Pediatrics — Buffalo

Идентификаторы

NCT: NCT06539312 · STUDY00007712 · R01MD018384

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗