Clinical trial NCT04942379: Asthma Link: A Real World Application of School Supervised Asthma Therapy
Official title: Asthma Link: A Real World Application of School Supervised Asthma Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Asthma
Keywords: asthma
childhood asthma
stakeholder engagement
medication adherence
school-supervised asthma therapy
real-world
pragmatic trial
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-06-28
Enrollment: 66
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Eligibility criteria: STUDY INCLUSION/EXCLUSION CRITERIA:

Child 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

Child 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.

Parent Exclusion Criteria:

* Adults lacking capacity
* Prisoners

Medical Provider, School Nurse, Asthma Champion Inclusion Criteria:

• Able and willing to provide informed consent

Medical Provider, School Nurse, Asthma Champion Exclusion Criteria:

• Unable or unwilling to provide informed consent

Child eligibility for children enrolled in Asthma Link:

* children aged 6-17 years (enrolled in grade 1-12)
* prescribed daily inhaled corticosteroid (ICS) for asthma
* 1 or more courses of oral steroids in the past 2 years OR 1 or more hospitalizations or ED visits for asthma in the past 2 years OR 1 or more sick visits for asthma in the past year OR Asthma Control Test (ACT) score \<19
* parent/child report of poor ICS adherence on adherence checklist- i.e. child or parent says "Yes" when provider asks if they have difficulty remembering to take their medication or if they regularly take medication holidays or breaks
* able and willing to assent
* parental permission
* English or Spanish speaking

Primary outcomes:
measure: Recruitment Procedures Assessed by Number of Patients Screened
timeFrame: Baseline
measure: Recruitment Procedures Assessed by Number of Eligible Participants
timeFrame: Baseline
measure: Recruitment Procedures Assessed by Number of Patients Recruited Into the Study
timeFrame: Baseline
measure: Recruitment Procedures Assessed by Number of Eligible Patients That Were Not Enrolled or Refused to Participate.
timeFrame: Baseline
measure: Retention of Study Participants (Drop Out)
timeFrame: Up to end of study, approximately 12 months
measure: Retention of Study Participants (Lost to Follow-up)
timeFrame: Up to end of study, approximately 12 months
measure: Intervention Fidelity - Pediatric Practice
timeFrame: Baseline
measure: Intervention Fidelity - Percentage of Enrolled Students Receiving Intervention
timeFrame: Up to end of study, approximately 12 months
measure: Intervention Fidelity - School Nurse and Family Participation
timeFrame: Up to end of study, approximately 12 months
Secondary outcomes:
measure: Acceptability - Participants
timeFrame: 3 months, 6 months, 12 months
measure: Adoption of Asthma Link Intervention - Medical Provider
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Adoption of Asthma Link Intervention - Participant
timeFrame: 3 months, 6 months, 12 months
measure: Adoption of Asthma Link Intervention - School Nurse
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Cost Effectiveness of Intervention
timeFrame: School nurses and pediatric practices 6 and 12 months/Parents 3, 6 and 12 months
measure: Sustainability of Intervention
timeFrame: 3 months, 6 months, 12 months
measure: Asthma Symptoms - Spirometry
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Asthma Symptoms - Asthma Control Test
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Asthma Symptoms - Maximum Symptoms Days
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Frequency of Healthcare Utilization Over Time
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Medication Adherence
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: School Absences
timeFrame: Baseline, 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
Study officials:
affiliation: University of Massachusetts Chan Medical School
name: Michelle Trivedi, MD
role: PRINCIPAL_INVESTIGATOR
References: