A Pilot Study to Improve Preventive Asthma Care for Urban Adolescents
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention
Sponsored by
About this trial
This is an interventional health services research trial for Asthma focused on measuring Asthma
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
Sites / Locations
- University of Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01106326
First Posted
April 16, 2010
Last Updated
July 25, 2014
Sponsor
University of Rochester
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT01106326
Brief Title
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
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Institutes of Health (NIH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Intervention
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of Symptom-free Days Over Two Weeks
Description
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.
Time Frame
2 and 4 month follow-up assessments
Secondary Outcome Measure Information:
Title
Additional Asthma Morbidity Measures
Description
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.
Time Frame
2 month, 4 month, final follow-up assessments
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill S. Halterman, MD, MPH
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24494626
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.
Results Reference
background
PubMed Identifier
21599562
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.
Results Reference
result
Learn more about this trial
A Pilot Study to Improve Preventive Asthma Care for Urban Adolescents
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