School-based Asthma Care for Teens (SB-ACT) (SB-ACT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02206061|
Recruitment Status : Active, not recruiting
First Posted : August 1, 2014
Last Update Posted : April 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Behavioral: School-Based Asthma Care for Teens (SB-ACT) Behavioral: Directly Observed Therapy Behavioral: Asthma Education||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||430 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||School-based Asthma Care for Teens (SB-ACT)|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||June 2021|
Experimental: 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.
Behavioral: School-Based Asthma Care for Teens (SB-ACT)
Active Comparator: 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).
Behavioral: Directly Observed Therapy
Active Comparator: 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.
Behavioral: Asthma Education
- Average number of days without asthma symptoms (Symptom Free Days) [ Time Frame: Average number of days, over 2 weeks, during post-intervention follow-up interviews (up to 12 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 (up to 12 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02206061
|United States, New York|
|University of Rochester|
|Rochester, New York, United States, 14642|