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Better Asthma Outcomes: Lowering Tobacco Smoke Exposure

Primary Purpose

Lung Diseases, Asthma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SHS reduction intervention based on social cognitive learning theory
Sponsored by
Palo Alto Medical Foundation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Diseases

Eligibility Criteria

3 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Age 3-12 years Kaiser member for >= 1 year >= 1 asthma care visit in prior year Persistent asthma likely based on prior year: Physician diagnosis code of persistent asthma OR >= 4 beta agonist (BA) dispensing events OR >= 4 Anti-inflammatory (AI) dispensing events Secondhand smoke exposure by parent report. Parent agrees to participate in a clinical trial of a smoke exposure reduction interventio

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    September 19, 2005
    Last Updated
    October 27, 2014
    Sponsor
    Palo Alto Medical Foundation
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00217958
    Brief Title
    Better Asthma Outcomes: Lowering Tobacco Smoke Exposure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2002 (undefined)
    Primary Completion Date
    April 2008 (Actual)
    Study Completion Date
    April 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Palo Alto Medical Foundation
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief Summary
    To improve disease outcomes through reduction in secondhand tobacco smoke exposure of children with asthma
    Detailed Description
    BACKGROUND: Secondhand tobacco smoke (SHS) exposure increases asthma morbidity in children. Efforts to reduce exposure have had mixed results. This study is a randomized controlled trial of an exposure reduction intervention, with objective feedback to parents on the child's exposure based on urine cotinine measurement, and counseling tailored to the child's specific exposure sources/locations and parental readiness to take specific actions to reduce exposure from each source/location. This trial involves 350 SHS-exposed children with persistent asthma, 3-12 years of age, receiving care from the Kaiser Health Care Program in Northern California. Primary outcomes over the 18 months of follow-up will be asthma acute care utilization and urine cotinine/creatine ratio. Changes in controller medication adherence will be evaluated using a pharmacy-based dispensing index. DESIGN NARRATIVE: Primary objective: To evaluate the efficacy of a behaviorally-based, cotinine-feedback-and-monitoring program designed to reduce SHS exposure in an 18-month randomized controlled trial (RCT) with 350 children with persistent asthma, 3-12 years of age, in comparison with usual medical care. Secondary objectives: 1) to investigate the behavioral mechanisms that mediate between the intervention and associated improvements in asthma outcomes, and 2) to determine the influence of initial caregiver stage of change with regard to smoking practices on response to the intervention. Hypotheses: Disease outcomes: A behaviorally-based, individually-tailored intervention that emphasizes SHS exposure reduction, provides sequential feedback to the parent on the child's urine cotinine level, and is tailored to the parent's stage of change with regard to smoking practices will be associated with decreased asthma crisis care utilization and improvements in secondary disease outcomes over an 18-month follow-up period when compared with usual medical care. ETS exposure: The SHS reduction intervention will be associated with lower SHS exposure at follow-up (assessed by urine cotinine/creatinine ratio), compared with usual medical care. Mechanism: Decreases in urine cotinine/creatinine ratio will be instrumental in intervention-associated improvements in asthma crisis care utilization.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Diseases, Asthma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    SHS reduction intervention based on social cognitive learning theory

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Age 3-12 years Kaiser member for >= 1 year >= 1 asthma care visit in prior year Persistent asthma likely based on prior year: Physician diagnosis code of persistent asthma OR >= 4 beta agonist (BA) dispensing events OR >= 4 Anti-inflammatory (AI) dispensing events Secondhand smoke exposure by parent report. Parent agrees to participate in a clinical trial of a smoke exposure reduction interventio
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sandra Wilson
    Organizational Affiliation
    Res Inst, Palo Alto Med Fdn
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    Citation
    Farber HJ, Wilson SR, Caine L, Bertorello L, Brown NL, Verghese S, Luna V, Quesenberry CP. Association between parent report of smoke exposure level, effect of smoke on child's asthma, and urine cotinine levels. Paper presented at the 2005 Annual Meeting of the American Thoracic Society, San Diago, CA, May 24, 2005. Proceedings of the American Thoracic Society; Vol.2 Abstracts Issue; 2005.
    Results Reference
    background
    Citation
    Wilson SR, Brown NL, Farber HJ, Luna V, Verghese S, Caine L, Bertorello L, Quesenberry CP. Sources of and caregiver readiness to reduce secondhand smoke (SHS) exposure of children with asthma. Poster presented at the 2005 Annual Meeting of the American Thoracic Society, San Diago, CA, May 24, 2005. Proceedings of the American Thoracic Society; Vol.2 Abstracts Issue; 2005.
    Results Reference
    background
    PubMed Identifier
    20864611
    Citation
    Wilson SR, Farber HJ, Knowles SB, Lavori PW. A randomized trial of parental behavioral counseling and cotinine feedback for lowering environmental tobacco smoke exposure in children with asthma: results of the LET'S Manage Asthma trial. Chest. 2011 Mar;139(3):581-590. doi: 10.1378/chest.10-0772. Epub 2010 Sep 23.
    Results Reference
    derived
    PubMed Identifier
    18339788
    Citation
    Farber HJ, Knowles SB, Brown NL, Caine L, Luna V, Qian Y, Lavori P, Wilson SR. Secondhand tobacco smoke in children with asthma: sources of and parental perceptions about exposure in children and parental readiness to change. Chest. 2008 Jun;133(6):1367-1374. doi: 10.1378/chest.07-2369. Epub 2008 Mar 13.
    Results Reference
    derived

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    Better Asthma Outcomes: Lowering Tobacco Smoke Exposure

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