Trial Outcomes & Findings for Asthma Link: A Real World Application of School Supervised Asthma Therapy (NCT NCT04942379)

NCT ID: NCT04942379

Last Updated: 2024-07-19

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

66 participants

Primary outcome timeframe

Baseline

Results posted on

2024-07-19

Participant Flow

Participant milestones

Participant milestones
Measure
Asthma Link
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. Asthma Link: Providers enroll patients in school nurse supervised daily controller asthma medication delivery
Enhanced Usual Care
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. Enhanced Usual Care: Providers counsel patients on behavioral strategies to improve medication adherence. Patients also receive an asthma workbook outlining behavioral strategies for asthma medication adherence.
Overall Study
STARTED
31
35
Overall Study
3 Months
29
34
Overall Study
6 Months
28
32
Overall Study
COMPLETED
27
32
Overall Study
NOT COMPLETED
4
3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Asthma Link
n=31 Participants
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. Asthma Link: Providers enroll patients in school nurse supervised daily controller asthma medication delivery
Enhanced Usual Care
n=35 Participants
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. Enhanced Usual Care: Providers counsel patients on behavioral strategies to improve medication adherence. Patients also receive an asthma workbook outlining behavioral strategies for asthma medication adherence.
Total
n=66 Participants
Total of all reporting groups
Age, Customized
< 18 years
31 Participants
n=39 Participants
35 Participants
n=41 Participants
66 Participants
n=35 Participants
Sex: Female, Male
Female
14 Participants
n=39 Participants
20 Participants
n=41 Participants
34 Participants
n=35 Participants
Sex: Female, Male
Male
17 Participants
n=39 Participants
15 Participants
n=41 Participants
32 Participants
n=35 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
23 Participants
n=39 Participants
20 Participants
n=41 Participants
43 Participants
n=35 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
8 Participants
n=39 Participants
15 Participants
n=41 Participants
23 Participants
n=35 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=39 Participants
0 Participants
n=41 Participants
0 Participants
n=35 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=39 Participants
0 Participants
n=41 Participants
0 Participants
n=35 Participants
Race (NIH/OMB)
Asian
0 Participants
n=39 Participants
2 Participants
n=41 Participants
2 Participants
n=35 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=39 Participants
0 Participants
n=41 Participants
0 Participants
n=35 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=39 Participants
5 Participants
n=41 Participants
6 Participants
n=35 Participants
Race (NIH/OMB)
White
8 Participants
n=39 Participants
15 Participants
n=41 Participants
23 Participants
n=35 Participants
Race (NIH/OMB)
More than one race
8 Participants
n=39 Participants
5 Participants
n=41 Participants
13 Participants
n=35 Participants
Race (NIH/OMB)
Unknown or Not Reported
14 Participants
n=39 Participants
8 Participants
n=41 Participants
22 Participants
n=35 Participants

PRIMARY outcome

Timeframe: Baseline

Population: These numbers reflect the total number of patients screened for eligibility.

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

Outcome measures

Outcome measures
Measure
Asthma Link
n=143 Participants
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. Asthma Link: Providers enroll patients in school nurse supervised daily controller asthma medication delivery
Enhanced Usual Care
n=208 Participants
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. Enhanced Usual Care: Providers counsel patients on behavioral strategies to improve medication adherence. Patients also receive an asthma workbook outlining behavioral strategies for asthma medication adherence.
Recruitment Procedures Assessed by Number of Patients Screened
143 Participants
208 Participants

PRIMARY outcome

Timeframe: Baseline

Population: These numbers reflect the number of participants who were eligible based on initial screening.

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

Outcome measures

Outcome measures
Measure
Asthma Link
n=143 Participants
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. Asthma Link: Providers enroll patients in school nurse supervised daily controller asthma medication delivery
Enhanced Usual Care
n=208 Participants
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. Enhanced Usual Care: Providers counsel patients on behavioral strategies to improve medication adherence. Patients also receive an asthma workbook outlining behavioral strategies for asthma medication adherence.
Recruitment Procedures Assessed by Number of Eligible Participants
66 Participants
55 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Overall number of participants analyzed reflects the number of participants who were eligible on initial screen.

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

Outcome measures

Outcome measures
Measure
Asthma Link
n=66 Participants
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. Asthma Link: Providers enroll patients in school nurse supervised daily controller asthma medication delivery
Enhanced Usual Care
n=55 Participants
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. Enhanced Usual Care: Providers counsel patients on behavioral strategies to improve medication adherence. Patients also receive an asthma workbook outlining behavioral strategies for asthma medication adherence.
Recruitment Procedures Assessed by Number of Patients Recruited Into the Study
31 Participants
35 Participants

PRIMARY outcome

Timeframe: Baseline

Population: These numbers reflect the number of eligible participants.

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.

Outcome measures

Outcome measures
Measure
Asthma Link
n=66 Participants
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. Asthma Link: Providers enroll patients in school nurse supervised daily controller asthma medication delivery
Enhanced Usual Care
n=55 Participants
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. Enhanced Usual Care: Providers counsel patients on behavioral strategies to improve medication adherence. Patients also receive an asthma workbook outlining behavioral strategies for asthma medication adherence.
Recruitment Procedures Assessed by Number of Eligible Patients That Were Not Enrolled or Refused to Participate.
35 Participants
20 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Asthma Link
n=31 Participants
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. Asthma Link: Providers enroll patients in school nurse supervised daily controller asthma medication delivery
Enhanced Usual Care
n=35 Participants
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. Enhanced Usual Care: Providers counsel patients on behavioral strategies to improve medication adherence. Patients also receive an asthma workbook outlining behavioral strategies for asthma medication adherence.
Retention of Study Participants (Drop Out)
0 Participants
0 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Asthma Link
n=31 Participants
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. Asthma Link: Providers enroll patients in school nurse supervised daily controller asthma medication delivery
Enhanced Usual Care
n=35 Participants
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. Enhanced Usual Care: Providers counsel patients on behavioral strategies to improve medication adherence. Patients also receive an asthma workbook outlining behavioral strategies for asthma medication adherence.
Retention of Study Participants (Lost to Follow-up)
4 Participants
3 Participants

PRIMARY outcome

Timeframe: Baseline

Population: These numbers reflect the number of patients eligible for the study.

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

Outcome measures

Outcome measures
Measure
Asthma Link
n=66 Participants
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. Asthma Link: Providers enroll patients in school nurse supervised daily controller asthma medication delivery
Enhanced Usual Care
n=55 Participants
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. Enhanced Usual Care: Providers counsel patients on behavioral strategies to improve medication adherence. Patients also receive an asthma workbook outlining behavioral strategies for asthma medication adherence.
Intervention Fidelity - Pediatric Practice
31 Participants
35 Participants

PRIMARY outcome

Timeframe: Up to end of study, approximately 12 months

Population: Participants in the Enhanced Usual Care group did not receive school supervised therapy.

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

Outcome measures

Outcome measures
Measure
Asthma Link
n=31 Participants
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. Asthma Link: Providers enroll patients in school nurse supervised daily controller asthma medication delivery
Enhanced Usual Care
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. Enhanced Usual Care: Providers counsel patients on behavioral strategies to improve medication adherence. Patients also receive an asthma workbook outlining behavioral strategies for asthma medication adherence.
Intervention Fidelity - Percentage of Enrolled Students Receiving Intervention
31 Participants
0 Participants

PRIMARY outcome

Timeframe: Up to end of study, approximately 12 months

Population: Participants in the Enhanced Usual Care group did not receive school supervised therapy.

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.

Outcome measures

Outcome measures
Measure
Asthma Link
n=31 Participants
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. Asthma Link: Providers enroll patients in school nurse supervised daily controller asthma medication delivery
Enhanced Usual Care
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. Enhanced Usual Care: Providers counsel patients on behavioral strategies to improve medication adherence. Patients also receive an asthma workbook outlining behavioral strategies for asthma medication adherence.
Intervention Fidelity - School Nurse and Family Participation
31 Participants
0 Participants

SECONDARY outcome

Timeframe: 3 months, 6 months, 12 months

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 3 months, 6 months, 12 months

Research staff will assess adoption of the intervention via Pediatric practice log to track number of providers offering Asthma Link.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months, 6 months, 12 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 3 months, 6 months, 12 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months, 6 months, 12 months

Research staff will use a survey questions to parents, pediatric practice staff and school staff

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 3 months, 6 months, 12 months

Research staff will assess asthma symptoms utilizing spirometry to measure Forced Expiratory Volume.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 3 months, 6 months, 12 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 3 months, 6 months, 12 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 3 months, 6 months, 12 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 3 months, 6 months, 12 months

Research staff will assess medication adherence via a survey questions administered to parents and through pharmacy refill data.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 3 months, 6 months, 12 months

Research staff will assess school absences via parent report and school nurse report

Outcome measures

Outcome data not reported

Adverse Events

Asthma Link

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Enhanced Usual Care

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michelle Trivedi

UMass Chan Medical School

Phone: 7744418086

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place