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Behavioural Intervention

School-Based Asthma Program for Childhood Asthma

N/A

Recruiting

Led By Stanley Szefler, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 5-12 years

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 48 months

Awards & highlights

Study Summary

This trial seeks to reduce asthma disparities in 5-12yo kids from low-income communities. A school-based program called BACK will be delivered with two strategies to improve asthma control and address social determinants of health. Data will be collected to refine a "dissemination playbook" to help other school systems adopt the program.

Who is the study for?

This trial is for children aged 5-12 with poorly controlled asthma, attending selected schools in rural Colorado that have high needs based on lunch subsidies or rural status. It's not for kids under 5 or over 12, or those whose asthma is already well-managed.Check my eligibility

What is being tested?

The trial tests two school-based strategies to manage childhood asthma: BACK-Standard (BACK-S) and an enhanced version (BACK-E). Both are delivered by school staff coordinated with healthcare providers to reduce asthma attacks and missed school days.See study design

What are the potential side effects?

Since the interventions involve non-medical changes like improved care coordination and education rather than drugs, traditional side effects aren't expected. However, there may be indirect impacts on the child's daily routine or stress levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 5 and 12 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Reach

Secondary outcome measures

Number of ED/UC visits

Number of episode requiring systemic steroid therapy

Number of hospitalizations

Other outcome measures

Actual Adoption at a staff level

Adoption at a setting level

Effectiveness based on asthma exacerbations

+6 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: BACK-SExperimental Treatment1 Intervention

The BACK -Standard package includes a tailor-and-adapt to context strategy of approaches necessary to implement BACK in schools based on our past work, operationalized as an implementation blueprint to coordinate with partner roles of child/family, schools, healthcare teams and community resource agencies. This includes a facilitation strategy to support problem-solving through regular learning collaborative meetings for asthma navigators (bi-weekly), school nurses (monthly to bi-monthly) and health care champions (quarterly).

Group II: BACK-EExperimental Treatment1 Intervention

The BACK-Enhanced package includes the BACK-Standard package plus an Enhanced strategy to develop interrelationships with students/family, schools, and community agencies providing resources to address social determinants of health.

Group III: Usual careActive Control1 Intervention

School nurses/schools randomized to usual care will continue to receive their usual care from school nurses and then subsequently provide the intervention given their asthma remains poorly controlled at the start of the next school year following enrollment.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,840 Previous Clinical Trials

47,851,624 Total Patients Enrolled

6 Trials studying Childhood Asthma

2,086 Patients Enrolled for Childhood Asthma

University of Colorado, DenverLead Sponsor

1,738 Previous Clinical Trials

2,149,026 Total Patients Enrolled

Stanley Szefler, MDPrincipal InvestigatorChildrens Hospital Colorado

4 Previous Clinical Trials

2,151 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are seniors, aged 70 and above, eligible for this experiment?

"This research seeks to include participants under the age of 12 and over 5 years old."

Answered by AI

Who is eligible for enrollment in this investigation?

"To be eligible for the trial, participants must have a childhood diagnosis of asthma and fall within the 5-12 age range. This study is aiming to recruit 500 individuals in total."

Answered by AI

Is this experiment still recruiting participants?

"Based on the information from clinicaltrials.gov, this study is in its active recruitment phase. The first listing for the trial was posted on September 1st 2023 and it has since been updated most recently on October 4th 2023."

Answered by AI

Can you provide an estimate of the number of North American medical facilities participating in this experiment?

"This study is currently operating in Colorado Springs, Ellicott and Fountain with 13 additional sites. Specifically Harrison 2 school district and Ellicott 22 school district are also included."

Answered by AI

How many participants are involved in this investigation?

"Yes, according to clinicaltrials.gov's information, the trial is open for recruitment and was first posted on September 1st 2023 before being updated last on October 4th of that same year. Five hundred participants are sought out from 13 different medical facilities."

Answered by AI

Recent research and studies

Implementation ScienceJournal

A Refined Compilation of Implementation Strategies: Results from the Expert Recommendations for Implementing Change (ERIC) Project

Powell, Byron J, Thomas J Waltz, Matthew J Chinman, Laura J Damschroder, Jeffrey L Smith, Monica M Matthieu, Enola K Proctor, and JoAnn E Kirchner. 2015. “A Refined Compilation of Implementation Strategies: Results from the Expert Recommendations for Implementing Change (ERIC) Project”. Implementation Science. Springer Science and Business Media LLC. doi:10.1186/s13012-015-0209-1.

Implementation ScienceJournal

Implementation Strategies: Recommendations for Specifying and Reporting

Proctor, Enola K, Byron J Powell, and J Curtis McMillen. 2013. “Implementation Strategies: Recommendations for Specifying and Reporting”. Implementation Science. Springer Science and Business Media LLC. doi:10.1186/1748-5908-8-139.

clinicaltrials.govStudy

Reducing Asthma Attacks in Disadvantaged School Children With Asthma

2023. "Reducing Asthma Attacks in Disadvantaged School Children With Asthma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06003569.