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A Pilot Study to Improve Preventive Asthma Care for Urban Adolescents

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jill Halterman, University of Rochester
ClinicalTrials.gov Identifier:
NCT01106326
First received: April 16, 2010
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Asthma
Behavioral: Intervention

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Pilot Study to Improve Preventive Asthma Care for Urban Adolescents

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Number of Symptom-free Days Over Two Weeks [ Time Frame: 2 and 4 month follow-up assessments ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Additional Asthma Morbidity Measures [ Time Frame: 2 month, 4 month, final follow-up assessments ] [ Designated as safety issue: No ]
    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.


Enrollment: 30
Study Start Date: September 2009
Study Completion Date: September 2012
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention

Teens participating in this study will have:

  1. directly observed administration of their daily preventive asthma medication at school, by the school nurse, for the first 6-8 weeks of the study
  2. 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).
Behavioral: Intervention

Teens participating in this study will have:

  1. directly observed administration of their daily preventive asthma medication at school, by the school nurse, for the first 6-8 weeks of the study
  2. 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).

  Eligibility

Ages Eligible for Study:   12 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01106326

Locations
United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Jill S. Halterman, MD, MPH University of Rochester
  More Information

Publications:
Responsible Party: Jill Halterman, Associate Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT01106326     History of Changes
Other Study ID Numbers: 28198
Study First Received: April 16, 2010
Results First Received: June 15, 2011
Last Updated: July 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 20, 2014