Effect of Using a Structured Tobacco Cessation Education Program
Recruitment status was Active, not recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | May 20, 2008 | ||||
| Last Updated Date | June 8, 2009 | ||||
| Start Date ICMJE | October 2007 | ||||
| Estimated Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Evaluate the effectiveness of using a structured tobacco cessation education program, CEASE,delivered by pediatric residents in the outpatient continuity clinic of the pediatric residency program in reducing the exposure of infants to second hand smoke. [ Time Frame: Begining of study and at completion of study ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00683228 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Evaluate the efficacy of using a second hand smoke exposure biomarker, Urine cotinine level measurement and feedback as an adjunct to counseling [ Time Frame: first visit, 4 month visit, 9 month visit ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Using a Structured Tobacco Cessation Education Program | ||||
| Official Title ICMJE | Effect of Using a Structured Tobacco Cessation Education Program in Resident Training on Reducing Secondhand Smoke Exposure in Children | ||||
| Brief Summary | This is a pilot study that aims to
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| Detailed Description | The WHO estimates that half the children in the world are exposed to secondhand smoke. Despite recent smoke free legislation across the country, an estimated 22 percent of children are still exposed in their home environments. These children have increased rates of lower respiratory illnesses, middle ear effusion, asthma, reduced lung function and SIDS. This study aims to evaluate the effectiveness of using a structured tobacco cessation education program, CEASE (Clinical Effort against Secondhand Smoke Exposure), delivered by pediatric residents in the outpatient continuity clinic of a pediatric residency program in reducing the exposure of infants to secondhand smoke. It will also evaluate the efficacy of using a secondhand smoke biomarker, urine cotinine level measurement and feedback as an adjunct to counseling. Residents(and faculty) whose continuity clinic will be doing the intervention will be receiving tailored training on CEASE NY. The control continuity residents and faculty will receive no additional training. Pre and Post test questionnaires will be administered to all residents of both continuity clinics to test effectiveness of the teaching intervention and use of cotinine level on knowledge and practice. Consecutive newborns with a history of smoking in their home will be recruited into the study ( 22 in each group) when they first establish care ( between days 3 and 15), using a screening question on the nurses portion of the well child form. The study coordinator will obtain consent for participation from those screening positive for smoking in the home. Once consent is obtained the newborns will be randomly assigned to either intervention or control group by the study coordinator. The intervention group will be assigned to a CEASE trained resident for follow-up continuity care. The controls will be assigned to a non- CEASE trained resident for follow-up care. The study coordinator will log the date, agreement/non-agreement to participate, and who the caregiver is (parent vs. other) and to what group they have been assigned, giving them a unique study number. To account for the possibility of dropout, we will recruit 22 infants into each group. Baseline urine samples will be obtained for both groups. The intervention group will receive specific CEASE materials (see attached) and counseling at 2, 4, 6, month well child visits and urine for cotinine will be obtained at 4 and 9 months. Intervention parents will be given feedback on the urine cotinine levels at the next well child visit. The control group will receive no intervention at 2, 4, 6 months. A urine cotinine level will be obtained and a follow-up questionnaire will be given at the 9 month visit to both group parents evaluating their readiness to quit/cut down smoking and their subjective perception of the efficacy of resident counseling. Baseline urine samples will be obtained for both groups. The intervention group will receive specific CEASE materials (see attached) and counseling at 2, 4, 6, month well child visits and urine for cotinine will be obtained at 4 and 9 months. Intervention parents will be given feedback on the urine cotinine levels at the next well child visit. Control Group will receive no intervention at 2, 4, 6 months. A urine cotinine level will be obtained and a follow-up questionnaire will be given at the 9 month visit to both group parents evaluating their readiness to quit/cut down smoking and their subjective perception of the efficacy of resident counseling. All children will receive a small age-appropriate toy at the 12 month well child check as a thank you for participating in the study |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Secondhand Smoke Exposure | ||||
| Intervention ICMJE | Behavioral: Counseling
Consecutive newborns exposed to secondhand smoke will be recruited into the study and randomized to have parents receive or not receive specific counselling on harmful effects of SHS exposure. Urine cotinine will be measured at several points during teh sudy for each group |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Estimated Completion Date | March 2009 | ||||
| Estimated Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | up to 15 Days | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00683228 | ||||
| Other Study ID Numbers ICMJE | 5538 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Donna Bacchi M.D., MPH/ Principal Investigator, SUNY Upstate Medical University | ||||
| Study Sponsor ICMJE | State University of New York - Upstate Medical University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | State University of New York - Upstate Medical University | ||||
| Verification Date | June 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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