Smoking Cessation
Conditions
Keywords
Smoking cessation, Nicotine, Spirometry, Internal medicine
Brief summary
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).
Detailed description
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.
Interventions
Sponsors
Novartis
Soroka University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Admitted to Internal Medicine at Soroka University Medical Center. 2. Current cigarette smokers (≥ 10 cigarettes per day) 3. Provided written informed consent.
Exclusion criteria
1. Substance abuse (except for tobacco). 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite outcome: •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 | Within six months since discharge | 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. |
Countries
Israel
Contacts
Primary ContactTali Shafat, MD
Backup ContactNimrod Maimon, MD
Outcome results
None listed