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

NCT04942379 | Completed Results

• 2 other identifiers: H000163785K23HL150341
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to assess the feasibility of a clinical trial to evaluate the impact and process of deploying school-supervised asthma therapy in a real-world setting for children with poorly controlled asthma (aged 6-17 years).

Conditions

Childhood Asthma

Keywords

asthma; childhood asthma; stakeholder engagement; medication adherence; school-supervised asthma therapy; real-world; pragmatic trial

Outcome Measures

Primary Outcomes (9)

• Recruitment Procedures Assessed by Number of Patients Screened

  Research staff will track number of patients screened during enrollment process.

  Baseline

• Recruitment Procedures Assessed by Number of Eligible Participants

  Research staff will track number of eligible participants who meeting study criteria during the enrollment process.

  Baseline

• Recruitment Procedures Assessed by Number of Patients Recruited Into the Study

  Research staff will track number of patients recruited into the study after they are assessed for eligibility.

  Baseline

• Recruitment Procedures Assessed by Number of Eligible Patients That Were Not Enrolled or Refused to Participate.

  Research staff will track the number of patients that were not enrolled or refused to participate in the study along with the reasons for non-enrollment.

  Baseline

• Retention of Study Participants (Drop Out)

  Research staff to track number of participants who drop out of the study and note reasons for not completing study.

  Up to end of study, approximately 12 months

• Retention of Study Participants (Lost to Follow-up)

  Research staff to track number of participants lost to follow-up, who did not complete the 12 month study assessment.

  Up to end of study, approximately 12 months

• Intervention Fidelity - Pediatric Practice

  Research staff to assess for intervention fidelity within the pediatric practice through a checklist for pediatric staff to assess percentage of eligible children enrolled.

  Baseline

• Intervention Fidelity - Percentage of Enrolled Students Receiving Intervention

  Research staff to assess for intervention fidelity by school nurse report of percentage of enrolled students receiving supervised therapy.

  Up to end of study, approximately 12 months

• Intervention Fidelity - School Nurse and Family Participation

  Research staff to assess for intervention fidelity by school nurse checklist of each enrolled child attending daily school nurse sessions and his/her family bringing medication to school.

  Up to end of study, approximately 12 months

Secondary Outcomes (12)

• Acceptability - Participants

  3 months, 6 months, 12 months

• Adoption of Asthma Link Intervention - Medical Provider

  Baseline, 3 months, 6 months, 12 months

• Adoption of Asthma Link Intervention - Participant

  3 months, 6 months, 12 months

• Adoption of Asthma Link Intervention - School Nurse

  Baseline, 3 months, 6 months, 12 months

• Cost Effectiveness of Intervention

  School nurses and pediatric practices 6 and 12 months/Parents 3, 6 and 12 months

Study Arms (2)

Asthma Link

EXPERIMENTAL

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.

Other: Asthma Link

Enhanced Usual Care

ACTIVE COMPARATOR

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.

Other: Enhanced Usual Care

Interventions

Asthma Link OTHER

Providers enroll patients in school nurse supervised daily controller asthma medication delivery

Asthma Link

Enhanced Usual Care OTHER

Providers counsel patients on behavioral strategies to improve medication adherence. Patients also receive an asthma workbook outlining behavioral strategies for asthma medication adherence.

Enhanced Usual Care

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• Meet the eligibility criteria for Asthma Link (as described below)
• Enrolled in Asthma Link (if randomized to the Asthma Link Condition)
• Able and willing to provide informed assent
• Unable or unwilling to provide informed assent
• Diagnosis of a serious co-morbid illness during the past 5 years
• Developmental delay that would prevent study participation.
• Planning on moving from primary residence or moving outside of the school district in the next 1 year
• A sibling to a child participating in this study
• Parent/guardian to patient
• years or older
• Able to understand and communicate in English or Spanish
• Able and willing to provide informed consent.
• Adults lacking capacity
• Prisoners
• Able and willing to provide informed consent

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Massachusetts

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Asthma; Medication Adherence

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Dr. Michelle Trivedi
• Organization: UMass Chan Medical School

Michelle.Trivedi3@umassmed.edu

7744418086

Study Officials

• Michelle Trivedi, MD

  University of Massachusetts Chan Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: June 28, 2021
• Study Start: August 10, 2021
• Primary Completion: March 27, 2023
• Study Completion: August 22, 2023
• Last Updated: July 19, 2024
• Results First Posted: June 6, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)