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School-based Asthma Care for Teens (SB-ACT) (SB-ACT)

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ClinicalTrials.gov Identifier: NCT02206061
Recruitment Status : Active, not recruiting
First Posted : August 1, 2014
Last Update Posted : April 5, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jill Halterman, University of Rochester

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 430 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   12 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
National Heart, Lung, and Blood Institute (NHLBI)

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Responsible Party: Jill Halterman, Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT02206061     History of Changes
Other Study ID Numbers: 51912
R18HL116244-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 1, 2014    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases