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Clinical Trials/NCT01106326
NCT01106326CompletedNot Applicable

A Pilot Study to Improve Preventive Asthma Care for Urban Adolescents

University of Rochester2 sites in 1 country30 target enrollmentStarted: September 2009Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
2
Primary Endpoint
Number of Symptom-free Days Over Two Weeks

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
12 Years to 15 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Number of Symptom-free Days Over Two Weeks

Time Frame: 2 and 4 month follow-up assessments

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.

Secondary Outcomes

  • Additional Asthma Morbidity Measures(2 month, 4 month, final follow-up assessments)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jill Halterman

Associate Professor

University of Rochester

Study Sites (2)

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