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NCT02206061 · ClinicalTrials.gov registry record · NA
School-based Asthma Care for Teens (SB-ACT)
A NA study, sponsored by University of Rochester.
- Completed
- Registry status
- NA
- Development phase
- 430
- Enrollment target
NCT02206061: Completed NA study, sponsored by University of Rochester.
NCT02206061 is a NA study that has completed, run by University of Rochester. The registered enrollment target is 430 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02206061, a NA study, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- NA
- Development phase
- 430 participants
- Enrollment target
Study 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.
Primary Outcome
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 da
Interventions
- BEHAVIORAL Directly Observed Therapy
- BEHAVIORAL Asthma Education
- BEHAVIORAL School-Based Asthma Care for Teens (SB-ACT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 430 participants |
| Start Date | 2014-07 |
| Est. Completion | 2021-02-01 |
| Phase | NA |
What the finished NCT02206061 record still lists
NCT02206061 is an interventional study that assigns participants to a tested intervention. The registered 430 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 3 interventions - of which Directly Observed Therapy is the first listed.
NCT02206061 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02206061 about?
NCT02206061 is a clinical study titled "School-based Asthma Care for Teens (SB-ACT)". 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 t...
What is the current status of trial NCT02206061?
This trial is currently completed. It is a NA study. The enrollment target is 430 participants. The study started on 2014-07. Estimated completion is 2021-02-01.
What interventions are being tested in trial NCT02206061?
The interventions under investigation include: Directly Observed Therapy (BEHAVIORAL), Asthma Education (BEHAVIORAL), School-Based Asthma Care for Teens (SB-ACT) (BEHAVIORAL).
Who is sponsoring clinical trial NCT02206061?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02206061's enrollment target sits among peer trials
430 235th of 2000 higher than 1,765 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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