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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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The objective of the study is to assess the effect of in-hospital intensive counseling and NRT (nicotine replacement therapy) vs. usual care, on smoking cessation or enrollment to smoking cessation behavioral intervention.
This is prospective randomized clinical trial. The study population will include smokers subjects admitted to internal medicine departments at Soroka University Medical Center.
The study population will be divided randomly into three arms according to intervention intensity (ratio 1:1:1).
Prospective randomized clinical trial. The study population will include smokers subjects admitted to internal medicine departments at Soroka University Medical Center.
The study population will be divided randomly into three arms according to intervention intensity (ratio 1:1:1):
Group 1 - Usual care including medical advice to quit and confrontation with abnormal spirometry results if relevant.
Group 2 - Intensive counseling (15 minutes) by a smoking cessation counselor including confrontation with abnormal spirometry results if relevant, and follow up for at least 5 weeks after discharge (will be done weekly by phone for five consecutive weeks).
Group 3 - Intensive counseling (15 minutes) by a smoking cessation counselor including confrontation with abnormal spirometry results if relevant, offering and providing nicotine replacement therapy (NRT) and follow up (will be done weekly by phone for five consecutive weeks).
All participants will be given a smoking cessation leaflet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Other | Usual care including medical advice to quit and confrontation with abnormal spirometry results if relevant. |
|
| Group 2 | Other | Intensive counseling (15 minutes) by a smoking cessation counselor including confrontation with abnormal spirometry results if relevant, and follow up for at least 5 weeks after discharge (will be done weekly by phone for five consecutive weeks). |
|
| Group 3 | Other | Intensive counseling (15 minutes) by a smoking cessation counselor including confrontation with abnormal spirometry results if relevant, offering and providing nicotine replacement therapy (NRT) and follow up (will be done weekly by phone for five consecutive weeks). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine replacement therapy | Drug |
| ||
| Intensive counseling |
| Measure | Description | Time Frame |
|---|---|---|
| Composite outcome: ā¢Enrollment to a cessation behavioral intervention program according to participation in first two meetings of group therapy or personal counseling ⢠Smoking cessation validated by CO exhale test<5 ppm | The need for composite primary outcome based on the hypothesis that in Israel, the best supported way to quit smoking in by participating in group or personal counseling, with 50% success rate of smoking cessation. | Within six months since discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tali Shafat, MD | Contact | 2li.shafat@gmail.com | ||
| Nimrod Maimon, MD | Contact | nimrod.maimon@clalit.org.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soroka University Medical Center | Recruiting | Beersheba | 8410101 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18852395 | Result | Rigotti NA, Munafo MR, Stead LF. Smoking cessation interventions for hospitalized smokers: a systematic review. Arch Intern Med. 2008 Oct 13;168(18):1950-60. doi: 10.1001/archinte.168.18.1950. | |
| Result | US Department of Health & Human Services. The Health Consequences of Smoking: A Report of the Surgeon General. 2004. Accessed at www.surgeongeneral.gov/library/smokingconsequences/ on October 31, 2011. | ||
| 22417200 |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000095488 | Nicotine Replacement Therapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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|
| Medical advice | Behavioral |
|
| Result |
| Fiore MC, Goplerud E, Schroeder SA. The Joint Commission's new tobacco-cessation measures--will hospitals do the right thing? N Engl J Med. 2012 Mar 29;366(13):1172-4. doi: 10.1056/NEJMp1115176. Epub 2012 Mar 14. No abstract available. |
| 15266423 | Result | Silagy C, Lancaster T, Stead L, Mant D, Fowler G. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2004;(3):CD000146. doi: 10.1002/14651858.CD000146.pub2. |
| 10606193 | Result | Rigotti NA, Arnsten JH, McKool KM, Wood-Reid KM, Singer DE, Pasternak RC. The use of nicotine-replacement therapy by hospitalized smokers. Am J Prev Med. 1999 Nov;17(4):255-9. doi: 10.1016/s0749-3797(99)00095-1. |
| 11784452 | Result | McRobbie H, Hajek P. Nicotine replacement therapy in patients with cardiovascular disease: guidelines for health professionals. Addiction. 2001 Nov;96(11):1547-51. doi: 10.1046/j.1360-0443.2001.961115472.x. |
| 23074432 | Result | Thabane M; COPD Working Group. Smoking cessation for patients with chronic obstructive pulmonary disease (COPD): an evidence-based analysis. Ont Health Technol Assess Ser. 2012;12(4):1-50. Epub 2012 Mar 1. |
| 19129277 | Result | Kotz D, Wesseling G, Huibers MJ, van Schayck OC. Efficacy of confronting smokers with airflow limitation for smoking cessation. Eur Respir J. 2009 Apr;33(4):754-62. doi: 10.1183/09031936.00116308. Epub 2009 Jan 7. |
| 15846610 | Result | Stead LF, Lancaster T. Group behaviour therapy programmes for smoking cessation. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD001007. doi: 10.1002/14651858.CD001007.pub2. |
| Result | Fiore MC, JaƩn CR, Baker TB, et al: Clinical practice guideline: treating tobacco use and dependence: 2008 update. Rockville, MD: U.S. Department of Health and Human Services, Public Health Service. Retrieved 2011-02-16. |
| Result | Israel health ministry report 2010, Accessed at: http://www.old.health.gov.il/download/pages/smoke10_290511.pdf |