A Pilot Study to Improve Preventive Asthma Care for Urban Adolescents

Asthma Clinical Trial

Official title:

A Pilot Study to Improve Preventive Asthma Care for Urban Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01106326
• Other study ID #: 28198
• Status: Completed
• Phase: N/A
• First received: April 16, 2010
• Last updated: July 25, 2014
• Start date: September 2009
• Est. completion date: September 2012

Study information

• Verified date: July 2014
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The goal of this pilot study is to implement directly observed therapy with preventive asthma medications through a partnership with the school nurse (with input and direction from the primary care provider) to assure that the teen receives guideline based preventive medications, and provide a motivational interviewing intervention to help the teen transition to independence with their medical treatment plan. We hypothesize that this community-based pilot intervention will; 1) be feasible and acceptable among this population and among school personnel, and 2) yield reduced asthma morbidity (symptom-free days, absenteeism, and emergency room / urgent care use for asthma care). We anticipate that enhancing preventive healthcare for urban teens with asthma through partnerships with schools will yield improved health, prevention of suffering, decreased absenteeism from school, and reduced healthcare costs. This new method of preventive care delivery could be sustained within the school nursing system, and could be implemented in schools nationwide. Further, it could be applied to other chronic illnesses affecting disadvantaged populations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2012
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 15 Years

Eligibility

Inclusion Criteria:

• Physician-diagnosed asthma

• Persistent asthma (criteria based on NHLBI guidelines).

• Age >12 and <15 years.

• Attending school in the Rochester City School District.

• Signed physician permission to enroll the child.

• Current prescription of a daily preventive asthma medication

• Parent or caregiver and the adolescent must consent to the intervention.

Exclusion Criteria:

• Inability to speak and understand English.

• No access to a working phone for follow-up surveys

• The family planning to leave the school district within fewer than 6 months.

• The teen having other significant medical conditions

• The teen having a diagnosed developmental condition per parent report.

• Adolescents in foster care or other situations in which consent cannot be obtained from a guardian.

• Adolescents that were previously enrolled in our School-Based Asthma Study

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• Intervention
Teens participating in this study will have: directly observed administration of their daily preventive asthma medication at school, by the school nurse, for the first 6-8 weeks of the study three counseling sessions with a study nurse trained in principles of motivational interviewing (MI), that are designed to enhance the teen's motivation to change health behaviors, with a focus on adherence to evidence-based preventive care guidelines (e.g.; preventive medications).

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Blaakman SW, Cohen A, Fagnano M, Halterman JS. Asthma medication adherence among urban teens: a qualitative analysis of barriers, facilitators and experiences with school-based care. J Asthma. 2014 Jun;51(5):522-9. doi: 10.3109/02770903.2014.885041. Epub 2014 Feb 7. — View Citation

Halterman JS, Riekert K, Bayer A, Fagnano M, Tremblay P, Blaakman S, Borrelli B. A pilot study to enhance preventive asthma care among urban adolescents with asthma. J Asthma. 2011 Jun;48(5):523-30. doi: 10.3109/02770903.2011.576741. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Symptom-free Days Over Two Weeks	We will measure number of symptom-free days at 2-months (at the end of the directly observed therapy phase) and 4-months (after their transition to independence with preventive medications). We anticipate that teens will experience more symptom-free days compared to baseline assessment.	2 and 4 month follow-up assessments	No
Secondary	Additional Asthma Morbidity Measures	We also will compare additional baseline asthma morbidity measures, quality of life, health care utilization, cotinine, and exhaled nitric oxide with outcomes at the follow-up assessments.	2 month, 4 month, final follow-up assessments	No