Smoking Cessation in Patients With COPD (SMOCC) in General Practice
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...
Brief Summary
Official Title: “Smoking Cessation in Patients With COPD (SMOCC) in General Practice”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
- Study Primary Completion Date: December 2002
Intervention(s) in this Clinical Trial
- Behavioral: 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.
- 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.
Arms, Groups and Cohorts in this Clinical Trial
- No Intervention: 1
- Usual Care
- Experimental: 2
- Multifacetted smoking cessation intervention (aimed at professional (training and education) and at patients (counseling + nicotine replacement)
- Experimental: 3
- Multifacetted smoking cessation intervention (aimed at professional (training and education) and at patients (counseling + nicotine replacement + bupropion-SR)
Outcome Measures for this Clinical Trial
Primary Measures
- Smoking cessation (point prevalence, both self reported as biochemical verified)
- Time Frame: 12 months
Safety Issue?: No
- Time Frame: 12 months
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 35 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: ZonMw: The Netherlands Organisation for Health Research and Development Other
Overall Clinical Trial Officials and Contacts
Annelies E Jacobs, PHD Study Chair Radboud University
Related Publications
Citations Reporting Results
Hilberink SR, Jacobs JE, Schlösser 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. Epub 2005 Sep 12.
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. Epub 2005 Oct 3.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00628225
Study ID Number: zonmw22000039
ClinicalTrials.gov Identifier: NCT00628225
Health Authority: The Netherlands: Maastricht University
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00628225
