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Trial NCT00296998

Resource URI: http://static.linkedct.org/resource/trials/NCT00296998
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/10391>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/16838>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/24200>
linkedct:brief_title School-Based Program to Enhance Asthma Medication Adherence
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/8850>
linkedct:condition <http://static.linkedct.org/resource/condition/1253>
linkedct:condition <http://static.linkedct.org/resource/condition/13077>
linkedct: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
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 10 Years
linkedct:eligibility_minimum_age 3 Years
linkedct:end_date June 2009
linkedct:enrollment 530 (xsd:int)
linkedct:firstreceived_date February 23, 2006
linkedct:id NCT00296998
linkedct:intervention <http://static.linkedct.org/resource/intervention/31178>
linkedct:intervention <http://static.linkedct.org/resource/intervention/31179>
rdfs:label Trial NCT00296998
linkedct:lastchanged_date February 12, 2009
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:location <http://static.linkedct.org/resource/location/157333>
linkedct:nct_id NCT00296998
linkedct:number_of_arms 3 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title School-Based Asthma Therapy: Stage 2 Effectiveness Study
linkedct:org_study_id 358
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/27849>
linkedct:overall_status Active, not recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00296998>
linkedct:phase N/A
linkedct:primary_completion_date March 2009
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/67974>
linkedct:secondary_id R01 HL079954-01A1
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/32189>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date August 2006
linkedct:study_design Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date February 2009