Asthma Clinical Trial
To improve disease outcomes through reduction in secondhand tobacco smoke exposure of children with asthma
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:
1. 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.
2. 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.
3. Mechanism: Decreases in urine cotinine/creatinine ratio will be instrumental in
intervention-associated improvements in asthma crisis care utilization.
;
Allocation: Randomized, Primary Purpose: Treatment
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