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.
COMPLETED
NA
66 participants
Baseline
2024-07-19
Participant Flow
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
| 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: BaselinePopulation: These numbers reflect the total number of patients screened for eligibility.
Research staff will track number of patients screened during enrollment process.
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: BaselinePopulation: 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
| 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: BaselinePopulation: 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
| 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: BaselinePopulation: 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
| 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 monthsResearch staff to track number of participants who drop out of the study and note reasons for not completing study.
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 monthsResearch staff to track number of participants lost to follow-up, who did not complete the 12 month study assessment.
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: BaselinePopulation: 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
| 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 monthsPopulation: 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
| 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 monthsPopulation: 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
| 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 monthsResearch 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 monthsResearch 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 monthsResearch 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 monthsResearch 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 monthsResearch 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 monthsResearch 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 monthsResearch 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 monthsResearch 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 monthsResearch 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 monthsResearch 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 monthsResearch 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 monthsResearch staff will assess school absences via parent report and school nurse report
Outcome measures
Outcome data not reported
Adverse Events
Asthma Link
Enhanced Usual Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place