Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217958
Status:
COMPLETED
Last Update Posted:
2014-10-28
First Post:
2005-09-19
Brief Title:
Better Asthma Outcomes Lowering Tobacco Smoke Exposure
Sponsor:
Palo Alto Medical Foundation
Organization:
Palo Alto Medical Foundation
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 childs exposure based on urine cotinine measurement and counseling tailored to the childs specific exposure sourceslocations and parental readiness to take specific actions to reduce exposure from each sourcelocation 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 cotininecreatine 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 childs urine cotinine level and is tailored to the parents 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 cotininecreatinine ratio compared with usual medical care
3 Mechanism Decreases in urine cotininecreatinine ratio will be instrumental in intervention-associated improvements in asthma crisis care utilization
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 childs exposure based on urine cotinine measurement and counseling tailored to the childs specific exposure sourceslocations and parental readiness to take specific actions to reduce exposure from each sourcelocation 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 cotininecreatine 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 childs urine cotinine level and is tailored to the parents 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 cotininecreatinine ratio compared with usual medical care
3 Mechanism Decreases in urine cotininecreatinine ratio will be instrumental in intervention-associated improvements in asthma crisis care utilization
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL070012 | NIH | None | httpsreporternihgovquickSearchR01HL070012 |