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

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
School-Based Asthma Care for Teens (SB-ACT)
Directly Observed Therapy
Asthma Education
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma

Eligibility Criteria

12 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Rochester

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

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

Directly Observed Therapy

Asthma Education

Arm Description

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.

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).

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 25, 2014
Last Updated
April 14, 2021
Sponsor
University of Rochester
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT02206061
Brief Title
School-based Asthma Care for Teens (SB-ACT)
Acronym
SB-ACT
Official Title
School-based Asthma Care for Teens (SB-ACT)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
July 2014 (Actual)
Primary Completion Date
March 2020 (Actual)
Study Completion Date
February 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
430 (Actual)

8. Arms, Groups, and Interventions

Arm Title
School-Based Asthma Care for Teens (SB-ACT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Directly Observed Therapy
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Asthma Education
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
School-Based Asthma Care for Teens (SB-ACT)
Intervention Type
Behavioral
Intervention Name(s)
Directly Observed Therapy
Intervention Type
Behavioral
Intervention Name(s)
Asthma Education
Primary Outcome Measure Information:
Title
Average Number of Days Without Asthma Symptoms (Symptom Free Days) During Post-intervention Follow-up Interviews (3, 5 and 7 Months)
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32969289
Citation
Frey SM, Fagnano M, Mammen JR, Halterman JS. Health-related internet use among adolescents with uncontrolled persistent asthma. J Asthma. 2021 Dec;58(12):1610-1615. doi: 10.1080/02770903.2020.1827420. Epub 2020 Oct 7.
Results Reference
background
PubMed Identifier
32534023
Citation
Stern J, Chen M, Jusko TA, Fagnano M, Jarvinen KM, Halterman JS. Food allergy in at-risk adolescents with asthma: A key area for focus. Ann Allergy Asthma Immunol. 2020 Oct;125(4):405-409.e1. doi: 10.1016/j.anai.2020.06.004. Epub 2020 Jun 10.
Results Reference
background
PubMed Identifier
31605762
Citation
Okelo SO, Bilderback AL, Fagnano M, Halterman JS. Validity of asthma disease direction, bother, and risk as self-reported asthma morbidity measures in urban teens. J Allergy Clin Immunol Pract. 2020 Mar;8(3):1129-1131.e2. doi: 10.1016/j.jaip.2019.09.026. Epub 2019 Oct 9. No abstract available.
Results Reference
background
PubMed Identifier
31264485
Citation
Frey SM, Jones MR, Goldstein NPN, Fagnano M, Halterman JS. Comparing inhaled medications reported by adolescents with persistent asthma and their caregivers. J Asthma. 2020 Sep;57(9):999-1005. doi: 10.1080/02770903.2019.1631342. Epub 2019 Jul 2.
Results Reference
background
PubMed Identifier
30578922
Citation
Shankar M, Fagnano M, Blaakman SW, Rhee H, Halterman JS. Depressive Symptoms Among Urban Adolescents with Asthma: A Focus for Providers. Acad Pediatr. 2019 Aug;19(6):608-614. doi: 10.1016/j.acap.2018.12.004. Epub 2018 Dec 20.
Results Reference
background
PubMed Identifier
30389202
Citation
Jones MR, Frey SM, Riekert K, Fagnano M, Halterman JS. Transition Readiness for Talking With Providers in Urban Youth With Asthma: Associations With Medication Management. J Adolesc Health. 2019 Feb;64(2):265-271. doi: 10.1016/j.jadohealth.2018.08.026. Epub 2018 Oct 30.
Results Reference
background
PubMed Identifier
30317005
Citation
Okelo SO, Bilderback AL, Fagnano M, Halterman JS. Validation of Asthma Control Assessment Among Urban Adolescents Using the Asthma Control and Communication Instrument. J Allergy Clin Immunol Pract. 2019 Mar;7(3):962-968.e1. doi: 10.1016/j.jaip.2018.10.001. Epub 2018 Oct 11.
Results Reference
background
PubMed Identifier
29369804
Citation
Frey SM, Jones MR, Goldstein N, Riekert K, Fagnano M, Halterman JS. Knowledge of Inhaled Therapy and Responsibility for Asthma Management Among Young Teens With Uncontrolled Persistent Asthma. Acad Pediatr. 2018 Apr;18(3):317-323. doi: 10.1016/j.acap.2018.01.006. Epub 2018 Jan 31.
Results Reference
background
PubMed Identifier
33307900
Citation
Halterman JS, Riekert KA, Fagnano M, Tremblay PJ, Blaakman SW, Tajon R, Wang H, Borrelli B. Effect of the School-Based Asthma Care for Teens (SB-ACT) program on asthma morbidity: a 3-arm randomized controlled trial. J Asthma. 2022 Mar;59(3):494-506. doi: 10.1080/02770903.2020.1856869. Epub 2021 Jan 8.
Results Reference
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School-based Asthma Care for Teens (SB-ACT)

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