Childhood AsthmaNCT04942379
Asthma Link: A Real World Application of School Supervised Asthma Therapy
A study testing Asthma Link in people with Childhood Asthma, run by University of Massachusetts, Worcester at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Childhood Asthma
- What is being tested?
- Asthma Link
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2021to 22 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts
Worcester, Massachusetts, 01655
About this study
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).
Read the 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).
- Conditions
- Childhood Asthma
- Being tested
- Asthma Link, Enhanced Usual Care
- Keywords
- asthma, childhood asthma, stakeholder engagement, medication adherence, school-supervised asthma therapy, real-world, pragmatic trial
- Medical subject headings
- Asthma, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asthma LinkOther
Providers enroll patients in school nurse supervised daily controller asthma medication delivery
Enhanced Usual CareOther
Providers counsel patients on behavioral strategies to improve medication adherence. Patients also receive an asthma workbook outlining behavioral strategies for asthma medication adherence.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Procedures Assessed by Number of Patients Screened
Research staff will track number of patients screened during enrollment process.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to end of study, approximately 12 months
Secondary outcomes (12)
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
Measured: 3 months, 6 months, 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.
Measured: Baseline, 3 months, 6 months, 12 months
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.
Measured: 3 months, 6 months, 12 months
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.
Measured: Baseline, 3 months, 6 months, 12 months
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
Measured: School nurses and pediatric practices 6 and 12 months/Parents 3, 6 and 12 months
Sustainability of Intervention
Research staff will use a survey questions to parents, pediatric practice staff and school staff
Measured: 3 months, 6 months, 12 months
Asthma Symptoms - Spirometry
Research staff will assess asthma symptoms utilizing spirometry to measure Forced Expiratory Volume.
Measured: Baseline, 3 months, 6 months, 12 months
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.
Measured: Baseline, 3 months, 6 months, 12 months
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.
Measured: Baseline, 3 months, 6 months, 12 months
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.
Measured: Baseline, 3 months, 6 months, 12 months
Medication Adherence
Research staff will assess medication adherence via a survey questions administered to parents and through pharmacy refill data.
Measured: Baseline, 3 months, 6 months, 12 months
School Absences
Research staff will assess school absences via parent report and school nurse report
Measured: Baseline, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start10 Aug 2021
- Primary completion27 Mar 2023
- Study completion22 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Childhood AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Michelle Trivedi, University of Massachusetts, Worcester
- Investigators
- Michelle Trivedi, MD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942379
- Sponsor's protocol ID
- H00016378
- Other IDs
- 5K23HL150341
- Status last verified
- Jul 2024
- First submitted
- 12 May 2021
- Last updated
- 19 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma Link: A Real World Application of School Supervised Asthma Therapy
- ClinicalTrials.gov ID
- NCT04942379
- Acronym / sponsor ID
- H00016378
- Conditions
- Childhood Asthma
- Keywords
- asthma, childhood asthma, stakeholder engagement, medication adherence, school-supervised asthma therapy, real-world, pragmatic trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 27 Mar 2023 (actual)
- Study completion
- 22 Aug 2023 (actual)
- First posted
- 28 Jun 2021 (actual)
- Results
- Posted 6 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma Link | Experimental | Other: Asthma LinkSite 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. |
| Enhanced Usual Care | Active comparator | Other: Enhanced Usual CareSites 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. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Asthma LinkProviders enroll patients in school nurse supervised daily controller asthma medication delivery | Other | Asthma Link |
| Enhanced Usual CareProviders counsel patients on behavioral strategies to improve medication adherence. Patients also receive an asthma workbook outlining behavioral strategies for asthma medication adherence. | Other | Enhanced Usual Care |
Primary outcome
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 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 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.
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.
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.
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.
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.
12 secondary outcomes
Acceptability - Participants
Time frame: 3 months, 6 months, 12 months
Adoption of Asthma Link Intervention - Medical Provider
Time frame: Baseline, 3 months, 6 months, 12 months
Adoption of Asthma Link Intervention - Participant
Time frame: 3 months, 6 months, 12 months
Adoption of Asthma Link Intervention - School Nurse
Time frame: Baseline, 3 months, 6 months, 12 months
Cost Effectiveness of Intervention
Time frame: School nurses and pediatric practices 6 and 12 months/Parents 3, 6 and 12 months
Sustainability of Intervention
Time frame: 3 months, 6 months, 12 months
Asthma Symptoms - Spirometry
Time frame: Baseline, 3 months, 6 months, 12 months
Asthma Symptoms - Asthma Control Test
Time frame: Baseline, 3 months, 6 months, 12 months
Asthma Symptoms - Maximum Symptoms Days
Time frame: Baseline, 3 months, 6 months, 12 months
Frequency of Healthcare Utilization Over Time
Time frame: Baseline, 3 months, 6 months, 12 months
Medication Adherence
Time frame: Baseline, 3 months, 6 months, 12 months
School Absences
Time frame: Baseline, 3 months, 6 months, 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Trivedi, MD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Asthma Link in people with Childhood Asthma, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Procedures Assessed by Number of Patients Screened (time frame: Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024; AzTrials last refreshed its copy on 26 Oct 2026.