Smoking Cessation in Patients With COPD (SMOCC) in General Practice

NCT ID: NCT00628225

Last Updated: 2008-10-17

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

667 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-03-31

Study Completion Date

2003-12-31

Brief Summary

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Background: Smoking cessation is the key element in the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD). The role of the general practice in assisting these patients with successful quitting smoking was suboptimal. Therefore we evaluated the effectiveness of two smoking cessation programs (counseling and nicotine replacement) for smokers with COPD in routine general practice, one with (CNB) and one without (CN) the combination with bupropion-SR, compared to usual care (UC) and explored the role of COPD symptoms in successful smoking cessation.

Method: RCT with 667 patients with COPD, 68 general practices were randomly allocated. The usual care group (UC) consisted of 148 patients (22 practices), the first intervention group (counseling plus nicotine replacement (CN) of 243 patients (21 practices) and the second intervention group of 276 patients (25 practices. Main outcome measure was (biochemically verified) point prevalence.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Keywords

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Smoking cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Usual Care

Group Type NO_INTERVENTION

No interventions assigned to this group

2

Multifacetted smoking cessation intervention (aimed at professional (training and education) and at patients (counseling + nicotine replacement)

Group Type EXPERIMENTAL

Counseling and Nicotine replacement (CN)

Intervention Type BEHAVIORAL

Professionals in general practice received a central training (4 hours) about smoking, smoking cessation and COPD. They received materials (leaflet, video, smoking cessation protocol and informationfolder). Moreover, professionals received a maximum of 4 practice visits from an outreach visitor. General practitioners were encouraged to advise nicotine replacement.

Smoking COPD patients received smoking cessation counseling and were advised to use nicotine replacement.

3

Multifacetted smoking cessation intervention (aimed at professional (training and education) and at patients (counseling + nicotine replacement + bupropion-SR)

Group Type EXPERIMENTAL

Counseling, Nicotine replacement and Bupropion (CNB)

Intervention Type BEHAVIORAL

Professionals in general practice received a central training (4 hours) about smoking, smoking cessation and COPD. They received materials (leaflet, video, smoking cessation protocol and informationfolder). Moreover, professionals received a maximum of 4 practice visits from an outreach visitor. The general practitioner was encouraged to advice the patients to use both nicotine replacements and Bupropion-SR.

Smoking COPD patients received smoking cessation counseling and were advised to use nicotine replacement and Bupropion-SR.

Interventions

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Counseling and Nicotine replacement (CN)

Professionals in general practice received a central training (4 hours) about smoking, smoking cessation and COPD. They received materials (leaflet, video, smoking cessation protocol and informationfolder). Moreover, professionals received a maximum of 4 practice visits from an outreach visitor. General practitioners were encouraged to advise nicotine replacement.

Smoking COPD patients received smoking cessation counseling and were advised to use nicotine replacement.

Intervention Type BEHAVIORAL

Counseling, Nicotine replacement and Bupropion (CNB)

Professionals in general practice received a central training (4 hours) about smoking, smoking cessation and COPD. They received materials (leaflet, video, smoking cessation protocol and informationfolder). Moreover, professionals received a maximum of 4 practice visits from an outreach visitor. The general practitioner was encouraged to advice the patients to use both nicotine replacements and Bupropion-SR.

Smoking COPD patients received smoking cessation counseling and were advised to use nicotine replacement and Bupropion-SR.

Intervention Type BEHAVIORAL

Other Intervention Names

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Bupropion-SR (Zyban)

Eligibility Criteria

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Inclusion Criteria

A software program using Anatomical Therapeutical Chemical (ATC) prescription codes and International Classification of Primary Care (ICPC) diagnosis codes selected potential patients with COPD. Criteria: age \>35 years and a diagnosis recorded as COPD or as ICPC code R95/96, or a prescription of at least three times of bronchodilators (ATC code R03a/bc) and/or prescription of at least two times of inhaled anti-inflammatory medication in the past year (ATC code R03). General practitioners (GPs) had to confirm the diagnosis of the selection. Patients were eligible to participate if they met the following criteria:

* Current smoking
* Suffering from COPD according to the GP's diagnosis
* In command of the Dutch language.

Exclusion Criteria

* Too ill
* Under control of a chest physician
* Serious physical or psychological comorbidity
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Netherlands Asthma Foundation

OTHER

Sponsor Role collaborator

Pharmacia

INDUSTRY

Sponsor Role collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role lead

Responsible Party

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Radboud University Nijmegen Medical Centre

Principal Investigators

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Annelies E Jacobs, PHD

Role: STUDY_CHAIR

Radboud University Medical Center

Locations

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Radboud University Nijmegen Medical Centre

Nijmegen, , Netherlands

Site Status

Countries

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Netherlands

References

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Hilberink SR, Jacobs JE, Schlosser M, Grol RP, de Vries H. Characteristics of patients with COPD in three motivational stages related to smoking cessation. Patient Educ Couns. 2006 Jun;61(3):449-57. doi: 10.1016/j.pec.2005.05.012. Epub 2005 Sep 12.

Reference Type RESULT
PMID: 16157462 (View on PubMed)

Hilberink SR, Jacobs JE, Bottema BJ, de Vries H, Grol RP. Smoking cessation in patients with COPD in daily general practice (SMOCC): six months' results. Prev Med. 2005 Nov-Dec;41(5-6):822-7. doi: 10.1016/j.ypmed.2005.08.003. Epub 2005 Oct 3.

Reference Type RESULT
PMID: 16203030 (View on PubMed)

Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.

Reference Type DERIVED
PMID: 37230961 (View on PubMed)

Hilberink SR, Jacobs JE, Breteler MH, de Vries H, Grol RP. General practice counseling for patients with chronic obstructive pulmonary disease to quit smoking: impact after 1 year of two complex interventions. Patient Educ Couns. 2011 Apr;83(1):120-4. doi: 10.1016/j.pec.2010.04.009. Epub 2010 Apr 28.

Reference Type DERIVED
PMID: 20430565 (View on PubMed)

Other Identifiers

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GlaxoSmithKline ZYB40023

Identifier Type: -

Identifier Source: secondary_id

Pharmacia HK/jh/00013

Identifier Type: -

Identifier Source: secondary_id

Dutch Asthma Found. 3.4.98.47

Identifier Type: -

Identifier Source: secondary_id

zonmw22000039

Identifier Type: -

Identifier Source: org_study_id