In-patient Smoking Cessation Intervention Using Counseling, Spirometry and Nicotine Replacement Therapy

Soroka University Medical Center

Status: Unknown

Conditions: Smoking Cessation

Treatments: Drug: Nicotine replacement therapy; Behavioral: Medical advice; Behavioral: Intensive counseling

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02470923

SOR-0180-12-CTIL

Details and patient eligibility

About

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).

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Group 1

Other group

Description:

Usual care including medical advice to quit and confrontation with abnormal spirometry results if relevant.

Treatment:

Behavioral: Medical advice

Group 2

Other group

Description:

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).

Treatment:

Behavioral: Intensive counseling

Group 3

Other group

Description:

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).

Treatment:

Drug: Nicotine replacement therapy