School-Based Program to Enhance Asthma Medication Adherence - Full Text View

Sponsor:	National Heart, Lung, and Blood Institute (NHLBI)
Collaborator:	University of Rochester
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00296998

Purpose

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.

Condition	Intervention
Asthma Tobacco Use Disorder	Behavioral: School-Based Administration of Asthma Medication Behavioral: ETS Reduction Program

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	School-Based Asthma Therapy: Stage 2 Effectiveness Study

Resource links provided by NLM:

MedlinePlus related topics: Asthma

U.S. FDA Resources

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:

Average number of symptom-free days during peak winter season [ Time Frame: Measured from November to February of each year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Cost-effectiveness [ Time Frame: Measured from Years 1 to 3 ] [ Designated as safety issue: No ]

Estimated Enrollment:	530
Study Start Date:	August 2006
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental School-Based Administration of Asthma Medication	Behavioral: School-Based Administration of Asthma Medication Administration of Flovent or Advair by the school nurse each day the child is in school. Parents in this arm are provided with Flovent or Advair for home use on days the child is not in school.
2: Experimental ETS Reduction Program	Behavioral: ETS Reduction Program Administration of Flovent or Advair by the school nurse each day the child is in school. Parents in this arm are provided with Flovent or Advair for home use on days the child is not in school. In addition, parents of children randomized to the treatment group who are exposed to smoke will be counseled by a motivational interviewer in order to reduce the child's exposure to environmental tobacco smoke.
3: No Intervention

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

Ages Eligible for Study:	3 Years to 10 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00296998

Locations

United States, New York
University of Rochester
Rochester, New York, United States, 14642

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

University of Rochester

Investigators

Principal Investigator:

Jill S. Halterman, MD, MPH

University of Rochester

More Information

No publications provided

Responsible Party:	University of Rochester ( Jill S. Halterman, MD, MPH )
Study ID Numbers:	358, R01 HL079954-01A1
Study First Received:	February 23, 2006
Last Updated:	February 12, 2009
ClinicalTrials.gov Identifier:	NCT00296998 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):

Tobacco Dependence
Nicotine Dependence

Additional relevant MeSH terms:

Bronchial Diseases
Immune System Diseases
Tobacco Use Disorder
Asthma
Disorders of Environmental Origin
Lung Diseases, Obstructive
Hypersensitivity

Respiratory Tract Diseases
Mental Disorders
Lung Diseases
Hypersensitivity, Immediate
Substance-Related Disorders
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010