Clinical trial NCT01106326: A Pilot Study to Improve Preventive Asthma Care for Urban Adolescents
Official title: A Pilot Study to Improve Preventive Asthma Care for Urban Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2010-04-19
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Symptom-free Days Over Two Weeks
timeFrame: 2 and 4 month follow-up assessments
Secondary outcomes:
measure: Additional Asthma Morbidity Measures
timeFrame: 2 month, 4 month, final follow-up assessments
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Jill S. Halterman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.