Better Asthma Outcomes: Lowering Tobacco Smoke Exposure

Asthma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00217958
• Other study ID #: 295
• Secondary ID: R01HL070012
• Status: Completed
• Phase: N/A
• First received: September 19, 2005
• Last updated: October 27, 2014
• Start date: May 2002
• Est. completion date: April 2008

Study information

• Verified date: October 2014
• Source: Palo Alto Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

To improve disease outcomes through reduction in secondhand tobacco smoke exposure of children with asthma

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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 12 Years

Eligibility

• 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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Lung Diseases

Intervention

Behavioral:
• SHS reduction intervention based on social cognitive learning theory

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Palo Alto Medical Foundation	National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (2)

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.

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.