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
About this trial
This is an interventional treatment trial for Lung Diseases
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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00217958
First Posted
September 19, 2005
Last Updated
October 27, 2014
Sponsor
Palo Alto Medical Foundation
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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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