Trial Outcomes & Findings for School-based Asthma Care for Teens (SB-ACT) (NCT NCT02206061)
NCT ID: NCT02206061
Last Updated: 2021-05-14
Results Overview
The primary outcome measure is asthma morbidity between groups. The investigators will measure asthma morbidity by looking at the average number of days without asthma symptoms (symptom free days) over 2 weeks, during the post-intervention follow-up assessments (3, 5 and 7 months post baseline). Symptom free days are defined as 24 hour periods of no asthma symptoms including, coughing, wheezing, tightness in the chest or shortness of breath. Reported data reflects the number of symptom free days over 2 weeks averaged across 3, 5, and 7 month post-intervention follow-up assessments.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
430 participants
Primary outcome timeframe
Average number of symptom free days, over 2 weeks, averaged across 3, 5, and 7 month post-intervention follow-up assessments.
Results posted on
2021-05-14
Participant Flow
Participant milestones
| Measure |
School-Based Asthma Care for Teens (SB-ACT)
SB-ACT consists of 2 components: Motivational Interviewing (MI) and Directly Observed Therapy (DOT) For the first 6-8 weeks, the teen will visit the school nurse to receive a daily dose of preventive asthma medication as directly observed therapy (DOT). The purpose of DOT is to establish a relationship with the nurse, learn proper medication technique, and experience potential benefits of consistent preventive therapy.
The second component, Motivational Interviewing (MI) counseling , will start 4-6 weeks after the start of DOT. A counselor will conduct 3 in-person MI sessions with the teen at school to enhance the teen's motivation to adhere to their asthma treatment plan. The 3 sessions consist of an initial 40 minute counseling session (4-6 weeks after start of DOT), and two 30 minute follow-up sessions 2 and 6 weeks later. This component consists of an evidence-based self-management program to help the teen begin to transition to independence with preventive medication use.
School-Based Asthma Care for Teens (SB-ACT)
|
Directly Observed Therapy
For the first 6-8 weeks after enrollment, the teen will visit the school nurse once a day to receive a daily dose of preventive asthma medication as directly observed therapy (DOT).
Directly Observed Therapy
|
Asthma Education
Asthma educators will provide an in-school asthma education program that will match the time and attention of the MI counseling portion of the primary intervention. Each teen will receive three 1-on-1 educational sessions at school, and sessions will cover 3 main topics: 1) lung physiology and asthma basics, 2) triggers, symptoms, and warning signs, and 3) medications and self-advocacy.
Asthma Education
|
|---|---|---|---|
|
Overall Study
STARTED
|
149
|
142
|
139
|
|
Overall Study
COMPLETED
|
131
|
128
|
118
|
|
Overall Study
NOT COMPLETED
|
18
|
14
|
21
|
Reasons for withdrawal
| Measure |
School-Based Asthma Care for Teens (SB-ACT)
SB-ACT consists of 2 components: Motivational Interviewing (MI) and Directly Observed Therapy (DOT) For the first 6-8 weeks, the teen will visit the school nurse to receive a daily dose of preventive asthma medication as directly observed therapy (DOT). The purpose of DOT is to establish a relationship with the nurse, learn proper medication technique, and experience potential benefits of consistent preventive therapy.
The second component, Motivational Interviewing (MI) counseling , will start 4-6 weeks after the start of DOT. A counselor will conduct 3 in-person MI sessions with the teen at school to enhance the teen's motivation to adhere to their asthma treatment plan. The 3 sessions consist of an initial 40 minute counseling session (4-6 weeks after start of DOT), and two 30 minute follow-up sessions 2 and 6 weeks later. This component consists of an evidence-based self-management program to help the teen begin to transition to independence with preventive medication use.
School-Based Asthma Care for Teens (SB-ACT)
|
Directly Observed Therapy
For the first 6-8 weeks after enrollment, the teen will visit the school nurse once a day to receive a daily dose of preventive asthma medication as directly observed therapy (DOT).
Directly Observed Therapy
|
Asthma Education
Asthma educators will provide an in-school asthma education program that will match the time and attention of the MI counseling portion of the primary intervention. Each teen will receive three 1-on-1 educational sessions at school, and sessions will cover 3 main topics: 1) lung physiology and asthma basics, 2) triggers, symptoms, and warning signs, and 3) medications and self-advocacy.
Asthma Education
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
7
|
1
|
|
Overall Study
Lost to Follow-up
|
14
|
7
|
20
|
Baseline Characteristics
School-based Asthma Care for Teens (SB-ACT)
Baseline characteristics by cohort
| Measure |
School-Based Asthma Care for Teens (SB-ACT)
n=149 Participants
SB-ACT consists of 2 components: Motivational Interviewing (MI) and Directly Observed Therapy (DOT) For the first 6-8 weeks, the teen will visit the school nurse to receive a daily dose of preventive asthma medication as directly observed therapy (DOT). The purpose of DOT is to establish a relationship with the nurse, learn proper medication technique, and experience potential benefits of consistent preventive therapy.
The second component, Motivational Interviewing (MI) counseling , will start 4-6 weeks after the start of DOT. A counselor will conduct 3 in-person MI sessions with the teen at school to enhance the teen's motivation to adhere to their asthma treatment plan. The 3 sessions consist of an initial 40 minute counseling session (4-6 weeks after start of DOT), and two 30 minute follow-up sessions 2 and 6 weeks later. This component consists of an evidence-based self-management program to help the teen begin to transition to independence with preventive medication use.
School-Based Asthma Care for Teens (SB-ACT)
|
Directly Observed Therapy
n=142 Participants
For the first 6-8 weeks after enrollment, the teen will visit the school nurse once a day to receive a daily dose of preventive asthma medication as directly observed therapy (DOT).
Directly Observed Therapy
|
Asthma Education
n=139 Participants
Asthma educators will provide an in-school asthma education program that will match the time and attention of the MI counseling portion of the primary intervention. Each teen will receive three 1-on-1 educational sessions at school, and sessions will cover 3 main topics: 1) lung physiology and asthma basics, 2) triggers, symptoms, and warning signs, and 3) medications and self-advocacy.
Asthma Education
|
Total
n=430 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
13.4 years
STANDARD_DEVIATION 1.2 • n=99 Participants
|
13.4 years
STANDARD_DEVIATION 1.2 • n=107 Participants
|
13.5 years
STANDARD_DEVIATION 1.2 • n=206 Participants
|
13.4 years
STANDARD_DEVIATION 1.2 • n=7 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
190 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=99 Participants
|
87 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
240 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
102 Participants
n=99 Participants
|
92 Participants
n=107 Participants
|
97 Participants
n=206 Participants
|
291 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
139 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
82 Participants
n=99 Participants
|
78 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
239 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
61 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
164 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
149 participants
n=99 Participants
|
142 participants
n=107 Participants
|
139 participants
n=206 Participants
|
430 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Average number of symptom free days, over 2 weeks, averaged across 3, 5, and 7 month post-intervention follow-up assessments.The primary outcome measure is asthma morbidity between groups. The investigators will measure asthma morbidity by looking at the average number of days without asthma symptoms (symptom free days) over 2 weeks, during the post-intervention follow-up assessments (3, 5 and 7 months post baseline). Symptom free days are defined as 24 hour periods of no asthma symptoms including, coughing, wheezing, tightness in the chest or shortness of breath. Reported data reflects the number of symptom free days over 2 weeks averaged across 3, 5, and 7 month post-intervention follow-up assessments.
Outcome measures
| Measure |
School-Based Asthma Care for Teens (SB-ACT)
n=131 Participants
SB-ACT consists of 2 components: Motivational Interviewing (MI) and Directly Observed Therapy (DOT) For the first 6-8 weeks, the teen will visit the school nurse to receive a daily dose of preventive asthma medication as directly observed therapy (DOT). The purpose of DOT is to establish a relationship with the nurse, learn proper medication technique, and experience potential benefits of consistent preventive therapy.
The second component, Motivational Interviewing (MI) counseling , will start 4-6 weeks after the start of DOT. A counselor will conduct 3 in-person MI sessions with the teen at school to enhance the teen's motivation to adhere to their asthma treatment plan. The 3 sessions consist of an initial 40 minute counseling session (4-6 weeks after start of DOT), and two 30 minute follow-up sessions 2 and 6 weeks later. This component consists of an evidence-based self-management program to help the teen begin to transition to independence with preventive medication use.
School-Based Asthma Care for Teens (SB-ACT)
|
Directly Observed Therapy
n=128 Participants
For the first 6-8 weeks after enrollment, the teen will visit the school nurse once a day to receive a daily dose of preventive asthma medication as directly observed therapy (DOT).
Directly Observed Therapy
|
Asthma Education
n=118 Participants
Asthma educators will provide an in-school asthma education program that will match the time and attention of the MI counseling portion of the primary intervention. Each teen will receive three 1-on-1 educational sessions at school, and sessions will cover 3 main topics: 1) lung physiology and asthma basics, 2) triggers, symptoms, and warning signs, and 3) medications and self-advocacy.
Asthma Education
|
|---|---|---|---|
|
Average Number of Days Without Asthma Symptoms (Symptom Free Days) During Post-intervention Follow-up Interviews (3, 5 and 7 Months)
|
11.5 Days
Standard Deviation 2.9
|
11.4 Days
Standard Deviation 2.9
|
11.6 Days
Standard Deviation 2.8
|
Adverse Events
School-Based Asthma Care for Teens (SB-ACT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Directly Observed Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Asthma Education
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place