In-patient Smoking Cessation Intervention Using Counseling, Spirometry and Nicotine Replacement Therapy
NCT ID: NCT02470923
Last Updated: 2015-08-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2015-08-31
2017-07-31
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1
Usual care including medical advice to quit and confrontation with abnormal spirometry results if relevant.
Medical advice
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).
Intensive counseling
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).
Nicotine replacement therapy
Interventions
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Nicotine replacement therapy
Intensive counseling
Medical advice
Eligibility Criteria
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Inclusion Criteria
2. Current cigarette smokers (≥ 10 cigarettes per day)
3. Provided written informed consent.
Exclusion Criteria
2. Handicapped or bed ridden patients.
3. Patients who don't speak Hebrew, English, Russian or Arabic.
4. Medically not suitable for NRT-decided by physician on the basis of the patient's medical file.
18 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Soroka University Medical Center
OTHER
Responsible Party
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Locations
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Soroka University Medical Center
Beersheba, , Israel
Countries
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Central Contacts
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Facility Contacts
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Tali Shafat, MD
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Fiore MC, Jaén 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.
Israel health ministry report 2010, Accessed at: http://www.old.health.gov.il/download/pages/smoke10_290511.pdf
Other Identifiers
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SOR-0180-12-CTIL
Identifier Type: -
Identifier Source: org_study_id
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