Asthma Link: A Real World Application of School Supervised Asthma Therapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Childhood Asthma
- Sponsor
- University of Massachusetts, Worcester
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Retention of Study Participants (Lost to Follow-up)
- Status
- Completed
- Last Updated
- last year
Overview
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).
Detailed Description
The proposed 4-site pilot cluster randomized controlled trial will assess the feasibility of conducting a clinical trial of Asthma Link, a real-world school-supervised asthma therapy program. We will compare the impact of Asthma Link deployed in 2 pediatric practice sites versus Enhanced usual care deployed in 2 comparator sites, with 18 parent-child dyads enrolled per site (N=72 dyads). Primary trial outcomes will be participant recruitment, retention, and intervention fidelity. Secondary trial outcomes will be differences in the frequency of asthma symptoms, emergency department visits, hospital admissions, courses of oral corticosteroids, spirometry values, medication adherence and school absences between intervention and enhanced usual care sites at 3, 6 and 12 month follow up. Additionally we will assess process outcomes (acceptability, adoption, costs, sustainability).
Investigators
Michelle Trivedi
Assistant Professor
University of Massachusetts, Worcester
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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 Inclusion Criteria:
- •Parent/guardian to patient
- •18 years or older
- •Able to understand and communicate in English or Spanish
- •Able and willing to provide informed consent.
Outcomes
Primary Outcomes
Retention of Study Participants (Lost to Follow-up)
Time Frame: Up to end of study, approximately 12 months
Research staff to track number of participants lost to follow-up, who did not complete the 12 month study assessment.
Intervention Fidelity - Pediatric Practice
Time Frame: Baseline
Research staff to assess for intervention fidelity within the pediatric practice through a checklist for pediatric staff to assess percentage of eligible children enrolled.
Intervention Fidelity - Percentage of Enrolled Students Receiving Intervention
Time Frame: Up to end of study, approximately 12 months
Research staff to assess for intervention fidelity by school nurse report of percentage of enrolled students receiving supervised therapy.
Recruitment Procedures Assessed by Number of Patients Screened
Time Frame: Baseline
Research staff will track number of patients screened during enrollment process.
Recruitment Procedures Assessed by Number of Patients Recruited Into the Study
Time Frame: Baseline
Research staff will track number of patients recruited into the study after they are assessed for eligibility.
Retention of Study Participants (Drop Out)
Time Frame: Up to end of study, approximately 12 months
Research staff to track number of participants who drop out of the study and note reasons for not completing study.
Recruitment Procedures Assessed by Number of Eligible Participants
Time Frame: Baseline
Research staff will track number of eligible participants who meeting study criteria during the enrollment process.
Recruitment Procedures Assessed by Number of Eligible Patients That Were Not Enrolled or Refused to Participate.
Time Frame: Baseline
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.
Intervention Fidelity - School Nurse and Family Participation
Time Frame: Up to end of study, approximately 12 months
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.
Secondary Outcomes
- Acceptability - Participants(3 months, 6 months, 12 months)
- Adoption of Asthma Link Intervention - School Nurse(Baseline, 3 months, 6 months, 12 months)
- Sustainability of Intervention(3 months, 6 months, 12 months)
- Adoption of Asthma Link Intervention - Participant(3 months, 6 months, 12 months)
- Frequency of Healthcare Utilization Over Time(Baseline, 3 months, 6 months, 12 months)
- School Absences(Baseline, 3 months, 6 months, 12 months)
- Adoption of Asthma Link Intervention - Medical Provider(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)
- Asthma Symptoms - Spirometry(Baseline, 3 months, 6 months, 12 months)
- Asthma Symptoms - Asthma Control Test(Baseline, 3 months, 6 months, 12 months)
- Asthma Symptoms - Maximum Symptoms Days(Baseline, 3 months, 6 months, 12 months)
- Medication Adherence(Baseline, 3 months, 6 months, 12 months)