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Asthma Link for Childhood Asthma

N/A

Waitlist Available

Led By Michelle Trivedi, MD

Research Sponsored by University of Massachusetts, Worcester

Eligibility Criteria Checklist

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

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up school nurses and pediatric practices 6 and 12 months/parents 3, 6 and 12 months

Awards & highlights

Study Summary

This trial will test if a supervised asthma therapy program can help children with uncontrolled asthma in a real-world setting.

Eligible Conditions

Childhood Asthma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ school nurses and pediatric practices 6 and 12 months/parents 3, 6 and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~school nurses and pediatric practices 6 and 12 months/parents 3, 6 and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and school nurses and pediatric practices 6 and 12 months/parents 3, 6 and 12 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

Intervention Fidelity - Pediatric Practice

Intervention Fidelity - Percentage of enrolled students receiving intervention

Intervention Fidelity - School nurse and family participation

+6 more

Secondary outcome measures

Acceptability - Participants

Adoption of Asthma Link Intervention - Medical Provider

Adoption of Asthma Link Intervention - Participant

+9 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Asthma LinkExperimental Treatment1 Intervention

Site providers will be trained to efficiently discuss school-supervised medication administration with families and school nurses. Providers identify children with poorly controlled asthma and poor medication adherence and offer enrollment in Asthma Link to provide school-supervised asthma therapy. Ongoing communication occurs between the pediatric practice, school nurse and families through electronic medical record messaging and phone communication. Data will be collected at baseline (study entry) and at 3-, 6-and 12-month follow-up.

Group II: Enhanced Usual CareActive Control1 Intervention

Sites will receive pediatric pulmonologist-delivered training and a workbook for pediatric practices to provide to patients on behavioral strategies to help promote asthma medication adherence. Providers identify children with poorly controlled asthma and poor medication adherence and offer enrollment to this Enhanced Usual Care condition of study (receipt of workbook). Data will also be collected at baseline (study entry) and at 3-, 6-and 12-month follow-up.

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Who is running the clinical trial?

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

3,834 Previous Clinical Trials

47,310,569 Total Patients Enrolled

5 Trials studying Childhood Asthma

2,020 Patients Enrolled for Childhood Asthma

University of Massachusetts, WorcesterLead Sponsor

342 Previous Clinical Trials

976,544 Total Patients Enrolled

Michelle Trivedi, MDPrincipal InvestigatorUniversity of Massachusetts Chan Medical School

Frequently Asked Questions

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

Who meets the criteria to participate in this experiment?

"Eligible participants must be 6-17 years old and have a diagnosis of asthma. The total number of enrollees for this trial is 66 individuals."

Answered by AI

What results are researchers hoping to observe from this experiment?

"The main objective of this exploratory study, assessed in its baseline time frame is participant retention. Secondary goals include the cost effectiveness of the intervention, medication adherence levels determined via surveys and pharmacy refill data, as well as school absences reported by both parents and nurses."

Answered by AI

Does the eligibility criteria for this trial extend to those under 25 years of age?

"This clinical trial is open to children aged 6-17."

Answered by AI

Are there any vacancies in the trial for new participants?

"Research present on clinicaltrials.gov suggests that this medical trial is not actively seeking participants at the moment, having first been posted on August 10th 2021 and last updated June 3rd 2022. Nonetheless, there are 326 other studies currently recruiting patients all over the world."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Asthma Link: A Real World Application of School Supervised Asthma Therapy

Michelle Trivedi 2021. "Asthma Link: A Real World Application of School Supervised Asthma Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04942379.