Back to resultsAsthma Link: A Real World Application of School Supervised Asthma Therapy
Primary Purpose
Childhood Asthma
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Asthma Link
Enhanced Usual Care
Sponsored by
About this trial
This is an interventional health services research trial for Childhood Asthma focused on measuring asthma, childhood asthma, stakeholder engagement, medication adherence, school-supervised asthma therapy, real-world, pragmatic trial
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
Sites / Locations
- University of Massachusetts
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Asthma Link
Enhanced Usual Care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Recruitment procedures assessed by number of patients screened
Research staff will track number of patients screened during enrollment process.
Recruitment procedures assessed by number of eligible participants
Research staff will track number of eligible participants who meeting study criteria during the enrollment process.
Recruitment procedures assessed by number of patients recruited into the study
Research staff will track number of patients recruited into the study.
Recruitment procedures assessed by number of eligible patients that refused to participate.
Research staff will track the number of patients that refused to participate in the study along with the reasons for refusal.
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.
Retention of study participants (lost to follow-up)
Research staff to track number of participants lost to follow-up and reasons for not completing study.
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.
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.
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.
Secondary Outcome Measures
Acceptability - Participants
Research staff will assess acceptability of the study among stakeholders (parent-child dyads, medical providers, school nurses) via a survey in which we will ask stakeholders to rate each component of the Asthma Link intervention using a study specific Acceptability scale ranging from 1 (strongly disagree) to 5 (strongly agree). Qualitative interviews will be performed with stakeholders at 12 months
Adoption of Asthma Link Intervention - Medical Provider
Research staff will assess adoption of the intervention via Pediatric practice log to track number of providers offering Asthma Link.
Adoption of Asthma Link Intervention - Participant
Research staff will assess adoption of the intervention via survey to family at each survey timepoint of study to assess ability to obtain 2 inhalers (one for home and one for school) and deliver medicine to school.
Adoption of Asthma Link Intervention - School Nurse
Research staff will assess adoption of the intervention via school nurse log to track family bringing in medicine to school and frequency of child coming to nurses office to receive the medication.
Cost effectiveness of intervention
Research staff will use survey questions to assess time and costs for school nurses to review the toolkit and administer the intervention, pediatric providers to implement the program, and parents to participate in the intervention
Sustainability of Intervention
Research staff will use a survey questions to parents, pediatric practice staff and school staff
Asthma Symptoms - Spirometry
Research staff will assess asthma symptoms utilizing spirometry to measure Forced Expiratory Volume.
Asthma Symptoms - Asthma Control Test
Research staff will assess asthma symptoms utilizing the validated measure: Asthma Control Test (ACT) which consists of parent's assessment of level of control over child's asthma symptoms in the previous 4 weeks.
Asthma Symptoms - Maximum Symptoms Days
Research staff will assess asthma symptoms utilizing the validated measure: Maximum Symptom Days (the largest value of the number of days in the previous 2 weeks that a parent reports that their child experienced a) cough, wheezing, or shortness of breath, b) slowed activities due to symptoms, or 3)nocturnal awakening due to these symptoms.
Frequency of healthcare utilization over time
Research staff will assess the frequency of healthcare utilization (# of emergency room visits, # of hospital admissions, # of oral steroid courses, and # of urgent care visits) due to asthma through parent report on surveys and medical record review.
Medication Adherence
Research staff will assess medication adherence via a survey questions administered to parents and through pharmacy refill data.
School absences
Research staff will assess school absences via parent report and school nurse report
Full Information
NCT ID
NCT04942379
First Posted
May 12, 2021
Last Updated
June 1, 2023
Sponsor
University of Massachusetts, Worcester
1. Study Identification
Unique Protocol Identification Number
NCT04942379
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 10, 2021 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Asthma
Keywords
asthma, childhood asthma, stakeholder engagement, medication adherence, school-supervised asthma therapy, real-world, pragmatic trial
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Asthma Link
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhanced Usual Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Asthma Link
Intervention Description
Providers enroll patients in school nurse supervised daily controller asthma medication delivery
Intervention Type
Other
Intervention Name(s)
Enhanced Usual Care
Intervention Description
Providers counsel patients on behavioral strategies to improve medication adherence. Patients also receive an asthma workbook outlining behavioral strategies for asthma medication adherence.
Primary Outcome Measure Information:
Title
Recruitment procedures assessed by number of patients screened
Description
Research staff will track number of patients screened during enrollment process.
Time Frame
Baseline
Title
Recruitment procedures assessed by number of eligible participants
Description
Research staff will track number of eligible participants who meeting study criteria during the enrollment process.
Time Frame
Baseline
Title
Recruitment procedures assessed by number of patients recruited into the study
Description
Research staff will track number of patients recruited into the study.
Time Frame
Baseline
Title
Recruitment procedures assessed by number of eligible patients that refused to participate.
Description
Research staff will track the number of patients that refused to participate in the study along with the reasons for refusal.
Time Frame
Baseline
Title
Retention of study participants (drop out)
Description
Research staff to track number of participants who drop out of the study and note reasons for not completing study.
Time Frame
Up to end of study, approximately 12 months
Title
Retention of study participants (lost to follow-up)
Description
Research staff to track number of participants lost to follow-up and reasons for not completing study.
Time Frame
Up to end of study, approximately 12 months
Title
Intervention Fidelity - Pediatric Practice
Description
Research staff to assess for intervention fidelity within the pediatric practice through a checklist for pediatric staff to assess percentage of eligible children enrolled.
Time Frame
Baseline
Title
Intervention Fidelity - Percentage of enrolled students receiving intervention
Description
Research staff to assess for intervention fidelity by school nurse report of percentage of enrolled students receiving supervised therapy.
Time Frame
Up to end of study, approximately 12 months
Title
Intervention Fidelity - School nurse and family participation
Description
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.
Time Frame
Up to end of study, approximately 12 months
Secondary Outcome Measure Information:
Title
Acceptability - Participants
Description
Research staff will assess acceptability of the study among stakeholders (parent-child dyads, medical providers, school nurses) via a survey in which we will ask stakeholders to rate each component of the Asthma Link intervention using a study specific Acceptability scale ranging from 1 (strongly disagree) to 5 (strongly agree). Qualitative interviews will be performed with stakeholders at 12 months
Time Frame
3 months, 6 months, 12 months
Title
Adoption of Asthma Link Intervention - Medical Provider
Description
Research staff will assess adoption of the intervention via Pediatric practice log to track number of providers offering Asthma Link.
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Adoption of Asthma Link Intervention - Participant
Description
Research staff will assess adoption of the intervention via survey to family at each survey timepoint of study to assess ability to obtain 2 inhalers (one for home and one for school) and deliver medicine to school.
Time Frame
3 months, 6 months, 12 months
Title
Adoption of Asthma Link Intervention - School Nurse
Description
Research staff will assess adoption of the intervention via school nurse log to track family bringing in medicine to school and frequency of child coming to nurses office to receive the medication.
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Cost effectiveness of intervention
Description
Research staff will use survey questions to assess time and costs for school nurses to review the toolkit and administer the intervention, pediatric providers to implement the program, and parents to participate in the intervention
Time Frame
School nurses and pediatric practices 6 and 12 months/Parents 3, 6 and 12 months
Title
Sustainability of Intervention
Description
Research staff will use a survey questions to parents, pediatric practice staff and school staff
Time Frame
3 months, 6 months, 12 months
Title
Asthma Symptoms - Spirometry
Description
Research staff will assess asthma symptoms utilizing spirometry to measure Forced Expiratory Volume.
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Asthma Symptoms - Asthma Control Test
Description
Research staff will assess asthma symptoms utilizing the validated measure: Asthma Control Test (ACT) which consists of parent's assessment of level of control over child's asthma symptoms in the previous 4 weeks.
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Asthma Symptoms - Maximum Symptoms Days
Description
Research staff will assess asthma symptoms utilizing the validated measure: Maximum Symptom Days (the largest value of the number of days in the previous 2 weeks that a parent reports that their child experienced a) cough, wheezing, or shortness of breath, b) slowed activities due to symptoms, or 3)nocturnal awakening due to these symptoms.
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Frequency of healthcare utilization over time
Description
Research staff will assess the frequency of healthcare utilization (# of emergency room visits, # of hospital admissions, # of oral steroid courses, and # of urgent care visits) due to asthma through parent report on surveys and medical record review.
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Medication Adherence
Description
Research staff will assess medication adherence via a survey questions administered to parents and through pharmacy refill data.
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
School absences
Description
Research staff will assess school absences via parent report and school nurse report
Time Frame
Baseline, 3 months, 6 months, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Massachusetts
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Asthma Link: A Real World Application of School Supervised Asthma Therapy
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