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

Asthma Clinical Trial

— SB-ACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02206061
• Other study ID #: 51912
• Secondary ID: R18HL116244-01A1
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: February 1, 2021

Study information

• Verified date: March 2021
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 430
• Est. completion date: February 1, 2021
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• School-Based Asthma Care for Teens (SB-ACT)

• Directly Observed Therapy

• Asthma Education

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (9)

Frey SM, Fagnano M, Mammen JR, Halterman JS. Health-related internet use among adolescents with uncontrolled persistent asthma. J Asthma. 2020 Oct 7:1-6. doi: 10.1080/02770903.2020.1827420. [Epub ahead of print] — View 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. — View 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. — View 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. 2021 Jan 8:1-29. doi: 10.1080 — View 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. — View 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. — View 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. — View 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. — View Citation

Stern J, Chen M, Jusko TA, Fagnano M, Järvinen 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Average number of symptom free days, over 2 weeks, averaged across 3, 5, and 7 month post-intervention follow-up assessments.