School-Based Program to Enhance Asthma Medication Adherence
Information source: National Heart, Lung, and Blood Institute (NHLBI)
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma; Tobacco Use Disorder
Intervention: School-Based Administration of Asthma Medication (Behavioral); ETS Reduction Program (Behavioral)
Phase: N/A
Status: Recruiting
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI) Official(s) and/or principal investigator(s):
Jill S. Halterman, MD, MPH, Principal Investigator, Affiliation: University of Rochester
Overall contact:
Kelly M. Conn, MPH, Phone: 585-273-5693, Email: kelly_conn@urmc.rochester.edu
Summary
Past research has shown that childhood asthma can be effectively controlled by the use of
preventative medications on a daily basis. However, children often have difficulty adhering
to a daily medication regimen. This study will evaluate the effectiveness of a school-based
medication administration program, combined with a program to reduce tobacco exposure in the
home, at reducing asthma symptoms in children.
Clinical Details
Official title: School-Based Asthma Therapy: Stage 2 Effectiveness Study
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Primary outcome: Average number of symptom-free days during peak winter season
Secondary outcome: Cost-effectiveness
Detailed description:
Asthma prevalence has steadily increased in the United States since the early 1980s, with
infants and young children showing the largest increase. Children with persistent asthma may
be able to effectively control their symptoms by taking preventative medication on a daily
basis; however, poor medication adherence is a common problem, particularly among children in
poor urban areas of the country. Preliminary research has shown that administering
preventative asthma medications at school is an effective way to increase adherence. However,
in preliminary studies, beneficial effects were seen only among children not exposed to
environmental tobacco smoke (ETS) at home; more research is needed to confirm the benefit of
a school-based program in children exposed to ETS. The purpose of this study is to assess the
overall effectiveness of a school-based medication administration program combined with an
ETS reduction program at reducing asthma symptoms in children. The study will also evaluate
the program's cost-effectiveness and may serve as a model for improving asthma care for
children in urban communities.
Participation in this study will last 1 year. The study will enroll children with mild to
severe persistent asthma who are attending participating schools in the Rochester City School
District. Participants will be randomly assigned to either a school-based medication
administration program, in which they will receive asthma medication at school on a daily
basis, or to usual care, in which they will receive regular medical care. At study entry,
participants will undergo a saliva test to determine their level of tobacco smoke exposure;
parents will complete standardized written surveys to assess tobacco usage. Participants who
are exposed to tobacco smoke will take part in an ETS reduction program as well. This program
will encourage smoking cessation among family members and will focus on reducing total
household ETS exposure. It will consist of one 30-minute in-home counseling session a couple
of weeks following study entry, and two 15-minute follow-up phone calls to provide support
and reinforcement. Saliva tests and standardized questionnaires will be completed again at
Month 2 and at the final study visit. Telephone surveys will be conducted on a monthly basis
in between visits to assess asthma symptoms and levels of ETS exposure.
Eligibility
Minimum age: 3 Years.
Maximum age: 10 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Physician-diagnosed asthma (based on report from parent with confirmation from
physician)
- Mild to severe persistent asthma (criteria based on NHLBI guidelines), as determined
by 1 of the following 4 criteria:
1. Experiences asthma symptoms at least 2 days per week
2. Uses rescue medication at least 2 days per week
3. Experiences night-time asthma symptoms at least 2 days per month
4. Experienced at least 4 episodes of asthma during the past year that have lasted
more than 1 day and affected sleep
- Attending school at a participating preschool or elementary school in the Rochester
City School District
- Signed physician permission; the physician must agree with the need for a daily
inhaled corticosteroid and must sign an authorization form (any child without a
primary care provider will be offered assistance enrolling into a practice and may be
included in the study if their new provider authorizes participation)
Exclusion Criteria:
- Inability to speak and understand either English or Spanish
- No access to a working phone for follow-up surveys (either at home or an easily
accessible alternate home)
- Planning to leave the school district within 6 months of study entry
- Other significant medical conditions, including congenital heart disease, cystic
fibrosis, or other chronic lung disease, that could interfere with the assessment of
asthma-related outcome measures
- In foster care or other unstable living situation in which consent cannot be obtained
from a guardian; guardians unable to read will not be excluded because all
self-administered instruments will be given verbally
Locations and Contacts
Kelly M. Conn, MPH, Phone: 585-273-5693, Email: kelly_conn@urmc.rochester.edu
University of Rochester, Rochester, New York 14642, United States; Recruiting
Jill S. Halterman, MD, MPH, Principal Investigator
Additional Information
Starting date: August 2006
Ending date: June 2009
Last updated: August 7, 2008
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