Health TrialsbyHealthPanel

SMART-School-based Asthma Therapy

ConditionAsthma in Children
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorUniversity of Rochester

About this trial

The goal of this research trial is to: 1) Develop a SMART-SBAT protocol specifically designed for schools, 2) Evaluate the effectiveness of SMART-SBAT vs. usual care using a district wide, stepped-wedge type 1 cluster randomized trial and 3) Evaluate the process of implementing SMART-SBAT to contextualize effectiveness outcomes and inform future scale-up.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Physician-diagnosed asthma, with moderate-severe persistent symptoms or poor control based on NHLBI criteria

Age >=6 and =<12 years

Attending school in Rochester City School District

Caregiver >=18 years, and is able to understand and speak English or Spanish

Disqualifiers

Caregiver inability to speak and understand English or Spanish. (*Participants unable to read will be eligible, and all instruments will be given verbally.)

Having other significant medical conditions, including congenital heart disease, cystic fibrosis, or other chronic lung disease, that could interfere with the assessment of asthma-related measures.

In foster care or other situations in which consent cannot be obtained from a guardian.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SMART-SBAT

    Behavioral

    In coordination and approval by the child's primary care or specialist provider, children will receive a single maintenance and reliever therapy (SMART) inhaler for school-based asthma therapy (SBAT). Supervised by the school nurse, children will use their prescribed SMART inhaler each school day for preventive therapy, with additional doses as needed to relieve symptoms. Follow-up control assessments will determine if a step-up in therapy may be warranted, and follow-up provider visits will be initiated through school-based telemedicine or in-person visits. An Asthma Coordination team (nurse and community health worker) will be available to coordinate asthma care between providers, pharmacies, schools and families, and provide additional pragmatic support as needed.

  • Usual Care

    Behavioral

    Children enrolled in usual care schools will continue to receive asthma management through existing healthcare providers, schools will provide reliever inhalers as prescribed, and preventive asthma therapy is prescribed and delivered through normal channels. Each school year, all school nurses will receive a general orientation on guideline-based asthma management, including SMART and potential benefits of school-based asthma therapy, but standardized workflows or structured coordination will not be available for usual care schools. Caregivers and primary care providers will receive notifications of the child's asthma symptoms and recommendations for SMART therapy.

Treatment groups

330 Participants
are divided into 2 treatment groups
Group A: SMART-SBATExperimental treatment 1 intervention
Group B: Usual Care (UC)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of children with one or more acute health care visits due to asthma over 12 months

The percentage of children who experience one or more acute health care visits (emergency, urgent care) for asthma over 12 months

Time frame
12 months

Secondary outcomes

1

Mean number of symptom-free days in prior 14 days

Mean number of symptom-free days (24 hours without symptoms) in prior 14 days at each follow-up time point (3, 6, 9 and 12 months after baseline).

Time frame
12-month follow-ups
2

Mean number of nights with asthma symptoms in prior 2 weeks

Mean number of nights with asthma symptoms in the prior 14 days at each follow-up time point (3, 6, 9 and 12 months after baseline).

Time frame
12 months
3

Mean number of days requiring use of reliever medication in prior 14 days

Mean number of days requiring reliever therapy in the prior 14 days at each follow-up time point (3, 6, 9 and 12 months after baseline).

Time frame
12 months
4

Quality of Life Score at 12 months

Pediatric Asthma Caregiver Quality of Life score at each follow-up. Scores range from1-7, higher scores indicate better quality of life.

Time frame
12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Rochester

Lead sponsor

Michigan State University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: