A Pilot Study to Improve Preventive Asthma Care for Urban Adolescents

NCT01106326 | Completed Results

• 1 other identifier: 28198
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Asthma

Outcome Measures

Primary Outcomes (1)

• 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.

  2 and 4 month follow-up assessments

Secondary Outcomes (1)

• Additional Asthma Morbidity Measures

  2 month, 4 month, final follow-up assessments

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

Intervention BEHAVIORAL

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).

Intervention

Eligibility Criteria

• Age: 12 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (2)

• 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.

  PMID: 24494626 BACKGROUND

• 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.

  PMID: 21599562 RESULT

MeSH Terms

Conditions

Asthma

Interventions

Methods

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Maria Fagnano
• Organization: University of Rochester

maria_fagnano@urmc.rochester.edu

5852758220

Study Officials

• Jill S. Halterman, MD, MPH

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 16, 2010
• First Posted: April 19, 2010
• Study Start: September 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: September 1, 2012
• Last Updated: August 1, 2014
• Results First Posted: September 2, 2011

Record last verified: 2014-07

Locations

US (1)