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

August 24, 2015 updated by: Soroka University Medical Center

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Be'er-Sheva, Israel, 8410101
        • Recruiting
        • Soroka University Medical Center
        • Contact:
          • Tali Shafat, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group 1
Usual care including medical advice to quit and confrontation with abnormal spirometry results if relevant.
Behavioral: Medical advice
Other: 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).
Behavioral: Intensive counseling
Other: 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).
Drug: Nicotine replacement therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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.
Within six months since discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soroka University Medical Center

Collaborators

Novartis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

June 10, 2015

First Submitted That Met QC Criteria

June 10, 2015

First Posted (Estimate)

June 12, 2015

Study Record Updates

Last Update Posted (Estimate)

August 25, 2015

Last Update Submitted That Met QC Criteria

August 24, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOR-0180-12-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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