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

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Counseling and Nicotine replacement (CN)
Counseling, Nicotine replacement and Bupropion (CNB)
Sponsored by
ZonMw: The Netherlands Organisation for Health Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Smoking cessation

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Radboud University Nijmegen Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

1

2

3

Arm Description

Usual Care

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

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

Outcomes

Primary Outcome Measures

Smoking cessation (point prevalence, both self reported as biochemical verified)

Secondary Outcome Measures

Full Information

First Posted
February 25, 2008
Last Updated
October 16, 2008
Sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborators
The Netherlands Asthma Foundation, Pharmacia, GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00628225
Brief Title
Smoking Cessation in Patients With COPD (SMOCC) in General Practice
Acronym
SMOCC
Official Title
Smoking Cessation in Patients With COPD (SMOCC) in General Practice
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
March 2000 (undefined)
Primary Completion Date
December 2002 (Actual)
Study Completion Date
December 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborators
The Netherlands Asthma Foundation, Pharmacia, GlaxoSmithKline

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
Smoking cessation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
667 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
Usual Care
Arm Title
2
Arm Type
Experimental
Arm Description
Multifacetted smoking cessation intervention (aimed at professional (training and education) and at patients (counseling + nicotine replacement)
Arm Title
3
Arm Type
Experimental
Arm Description
Multifacetted smoking cessation intervention (aimed at professional (training and education) and at patients (counseling + nicotine replacement + bupropion-SR)
Intervention Type
Behavioral
Intervention Name(s)
Counseling and Nicotine replacement (CN)
Intervention Description
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
Intervention Name(s)
Counseling, Nicotine replacement and Bupropion (CNB)
Other Intervention Name(s)
Bupropion-SR (Zyban)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Smoking cessation (point prevalence, both self reported as biochemical verified)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annelies E Jacobs, PHD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Radboud University Nijmegen Medical Centre
City
Nijmegen
ZIP/Postal Code
6500HB
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
16157462
Citation
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.
Results Reference
result
PubMed Identifier
16203030
Citation
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.
Results Reference
result
PubMed Identifier
20430565
Citation
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.
Results Reference
derived

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

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