Asthma
Conditions
Brief summary
The goal of this study is to evaluate the widespread implementation of a developmentally appropriate preventive asthma care intervention for urban teens. The School Based Asthma Care for Teens (SB-ACT) program includes two core components: 1) a trial of directly observed therapy (DOT) to allow the teen to experience the potential benefits from adhering to guideline-based asthma treatment, and 2) a developmentally appropriate Motivational Interviewing (MI) Counseling Intervention to help the teen transition to independent long-term medication adherence. The investigators hypothesize that teens receiving the SB-ACT program will 1) experience less asthma-related morbidity than an asthma education (AE) attention-control comparison group, and 2) have improved adherence, less urgent healthcare use, less absenteeism, improved quality of life, and reduced FeNO compared to AE. The investigators also hypothesize that participants receiving DOT-only will have improved asthma-related outcomes immediately following their DOT trial vs. teens receiving AE, but will not have sustained, clinically significant improvement in outcomes once the DOT phase is complete. This represents a unique opportunity to build upon existing community relationships with an innovative and developmentally focused program to improve asthma outcomes for urban teens.
Interventions
BEHAVIORALSchool-Based Asthma Care for Teens (SB-ACT)
BEHAVIORALDirectly Observed Therapy
BEHAVIORALAsthma Education
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* Physician-diagnosed asthma * Persistent asthma or poor asthma control (based on NHLBI guidelines). * Attending secondary school in Rochester City School District
Exclusion criteria
* Inability to speak and understand English * No access to a phone for follow-up surveys * Diagnosed developmental or intellectual disability * Other significant medical conditions, including congenital heart disease, cystic fibrosis, or other chronic lung disease, that could interfere with the assessment of asthma-related measures. * Teens in foster care or other situations in which consent cannot be obtained from a guardian.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Number of Days Without Asthma Symptoms (Symptom Free Days) During Post-intervention Follow-up Interviews (3, 5 and 7 Months) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 149 |
| 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 | 142 |
| 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 | 139 |
| Total | 430 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 14 | 7 | 20 |
| Overall Study | Withdrawal by Subject | 4 | 7 | 1 |
Baseline characteristics
| Characteristic | School-Based Asthma Care for Teens (SB-ACT) | Total | Asthma Education | Directly Observed Therapy |
|---|---|---|---|---|
| Age, Continuous | 13.4 years STANDARD_DEVIATION 1.2 | 13.4 years STANDARD_DEVIATION 1.2 | 13.5 years STANDARD_DEVIATION 1.2 | 13.4 years STANDARD_DEVIATION 1.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 102 Participants | 291 Participants | 97 Participants | 92 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 47 Participants | 139 Participants | 42 Participants | 50 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 3 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 82 Participants | 239 Participants | 79 Participants | 78 Participants |
| Race (NIH/OMB) More than one race | 61 Participants | 164 Participants | 48 Participants | 55 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 5 Participants | 22 Participants | 10 Participants | 7 Participants |
| Region of Enrollment United States | 149 participants | 430 participants | 139 participants | 142 participants |
| Sex: Female, Male Female | 70 Participants | 190 Participants | 65 Participants | 55 Participants |
| Sex: Female, Male Male | 79 Participants | 240 Participants | 74 Participants | 87 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 149 | 0 / 142 | 0 / 139 |
| other Total, other adverse events | 0 / 140 | 0 / 142 | 0 / 139 |
| serious Total, serious adverse events | 0 / 149 | 0 / 142 | 0 / 139 |
Outcome results
Primary
Average Number of Days Without Asthma Symptoms (Symptom Free Days) During Post-intervention Follow-up Interviews (3, 5 and 7 Months)
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.
Time frame: Average number of symptom free days, over 2 weeks, averaged across 3, 5, and 7 month post-intervention follow-up assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| School-Based Asthma Care for Teens (SB-ACT) | 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 |
| Directly Observed Therapy | Average Number of Days Without Asthma Symptoms (Symptom Free Days) During Post-intervention Follow-up Interviews (3, 5 and 7 Months) | 11.4 Days | Standard Deviation 2.9 |
| Asthma Education | Average Number of Days Without Asthma Symptoms (Symptom Free Days) During Post-intervention Follow-up Interviews (3, 5 and 7 Months) | 11.6 Days | Standard Deviation 2.8 |
p-value: <0.05Regression, Linear