Lung DiseasesNCT00217958
Better Asthma Outcomes: Lowering Tobacco Smoke Exposure
A study testing SHS reduction intervention based on social cognitive learning theory in people with Lung Diseases and Asthma, run by Palo Alto Medical Foundation.
Trial summary
To improve disease outcomes through reduction in secondhand tobacco smoke exposure of children with asthma Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Lung Diseases, Asthma
- What is being tested?
- SHS reduction intervention based on social cognitive learning theory
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- May 2002to Apr 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
- 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
About this study
To improve disease outcomes through reduction in secondhand tobacco smoke exposure of children with asthma
Read the 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.
- Conditions
- Lung Diseases, Asthma
- Being tested
- SHS reduction intervention based on social cognitive learning theory
- Medical subject headings
- Lung Diseases, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHS reduction intervention based on social cognitive learning theoryBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMay 2002
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- Palo Alto Medical Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Sandra Wilson, Principal investigator, Res Inst, Palo Alto Med Fdn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00217958
- Sponsor's protocol ID
- 295
- Other IDs
- R01HL070012
- Status last verified
- Oct 2014
- First submitted
- 19 Sep 2005
- Last updated
- 28 Oct 2014
- Results posted
- No
Publications
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.
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.
PubMed 20864611Farber 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.
PubMed 18339788
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better Asthma Outcomes: Lowering Tobacco Smoke Exposure
- ClinicalTrials.gov ID
- NCT00217958
- Acronym / sponsor ID
- 295
- Conditions
- Lung Diseases, Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Palo Alto Medical FoundationUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- May 2002
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHS reduction intervention based on social cognitive learning theory | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2014.
- BackgroundFarber 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.
- BackgroundWilson 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.
- Derived from this study: PubMed 20864611Wilson 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.
- Derived from this study: PubMed 18339788Farber 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Wilson principal investigator
Res Inst, Palo Alto Med Fdn
Questions about this trial
What is this clinical trial studying?
A study testing SHS reduction intervention based on social cognitive learning theory in people with Lung Diseases and Asthma, run by Palo Alto Medical Foundation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00217958, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2014.