Sandra R Wilson1, Harold J Farber2, Sarah B Knowles3, Philip W Lavori4. 1. Department of Health Services Research, Palo Alto Medical Foundation Research Institute, Palo Alto, CA. Electronic address: Wilsons@pamfri.org. 2. Section of Pediatric Pulmonology, Baylor College of Medicine, Houston, TX. 3. Department of Health Services Research, Palo Alto Medical Foundation Research Institute, Palo Alto, CA. 4. Department of Health Research and Policy, Stanford University School of Medicine, Stanford, CA.
Abstract
BACKGROUND:Secondhand tobacco smoke exposure impairs the control of pediatric asthma. Evidence of the efficacy of interventions to reduce children's exposure and improve disease outcomes has been inconclusive. METHODS:Caregivers of 519 children aged 3 to 12 years with asthma and reported smoke exposure attended two baseline assessment visits, which involved a parent interview, sampling of the children's urine (for cotinine assay), and spirometry (children≥5 years). The caregivers and children (n=352) with significant documented exposure (cotinine≥10 ng/mL) attended a basic asthma education session, provided a third urine sample, and were randomized to the Lowering Environmental Tobacco Smoke: LET'S Manage Asthma (LET'S) intervention (n=178) or usual care (n=174). LET'S included three in-person, stage-of-change-based counseling sessions plus three follow-up phone calls. Cotinine feedback was given at each in-person session. Follow-up visits at 6 and 12 months postrandomization repeated the baseline data collection. Multivariate regression analyses estimated the intervention effect on the natural logarithm of the cotinine to creatinine ratio (lnCCR), use of health-care services, and other outcomes. RESULTS: In the sample overall, the children in the LET'S intervention had lower follow-up lnCCR values compared with the children in usual care, but the group difference was not significant (β coefficient=-0.307, P=.064), and there was no group difference in the odds of having>one asthma-related medical visit (β coefficient=0.035, P=.78). However, children with high-risk asthma had statistically lower follow-up lnCCR values compared with children in usual care (β coefficient=-1.068, P=.006). CONCLUSIONS: The LET'S intervention was not associated with a statistically significant reduction in tobacco smoke exposure or use of health-care services in the sample as a whole. However, it appeared effective in reducing exposure in children at high risk for subsequent exacerbations. TRIAL REGISTRY: ClinicialTrials.gov; No.: NCT00217958; URL: clinicaltrials.gov.
RCT Entities:
BACKGROUND: Secondhand tobacco smoke exposure impairs the control of pediatric asthma. Evidence of the efficacy of interventions to reduce children's exposure and improve disease outcomes has been inconclusive. METHODS: Caregivers of 519 children aged 3 to 12 years with asthma and reported smoke exposure attended two baseline assessment visits, which involved a parent interview, sampling of the children's urine (for cotinine assay), and spirometry (children≥5 years). The caregivers and children (n=352) with significant documented exposure (cotinine≥10 ng/mL) attended a basic asthma education session, provided a third urine sample, and were randomized to the Lowering Environmental Tobacco Smoke: LET'S Manage Asthma (LET'S) intervention (n=178) or usual care (n=174). LET'S included three in-person, stage-of-change-based counseling sessions plus three follow-up phone calls. Cotinine feedback was given at each in-person session. Follow-up visits at 6 and 12 months postrandomization repeated the baseline data collection. Multivariate regression analyses estimated the intervention effect on the natural logarithm of the cotinine to creatinine ratio (lnCCR), use of health-care services, and other outcomes. RESULTS: In the sample overall, the children in the LET'S intervention had lower follow-up lnCCR values compared with the children in usual care, but the group difference was not significant (β coefficient=-0.307, P=.064), and there was no group difference in the odds of having>one asthma-related medical visit (β coefficient=0.035, P=.78). However, children with high-risk asthma had statistically lower follow-up lnCCR values compared with children in usual care (β coefficient=-1.068, P=.006). CONCLUSIONS: The LET'S intervention was not associated with a statistically significant reduction in tobacco smoke exposure or use of health-care services in the sample as a whole. However, it appeared effective in reducing exposure in children at high risk for subsequent exacerbations. TRIAL REGISTRY: ClinicialTrials.gov; No.: NCT00217958; URL: clinicaltrials.gov.
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