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A Pilot Study to Improve Preventive Asthma Care for Urban Adolescents

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01106326
First Posted: April 19, 2010
Last Update Posted: August 1, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Jill Halterman, University of Rochester
  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: None (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 Jill Halterman, University of Rochester:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Additional Asthma Morbidity Measures [ Time Frame: 2 month, 4 month, final follow-up assessments ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01106326


Locations
United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
National Institutes of Health (NIH)
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
First Submitted: April 16, 2010
First Posted: April 19, 2010
Results First Submitted: June 15, 2011
Results First Posted: September 2, 2011
Last Update Posted: August 1, 2014
Last Verified: July 2014

Keywords provided by Jill Halterman, University of Rochester:
Asthma

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