The efficacy and cost-effectiveness of confrontational counselling for smoking cessation in smokers with previously undiagnosed COPD: a randomised controlled trial

ISRCTN ISRCTN64481813
DOI https://doi.org/10.1186/ISRCTN64481813
Secondary identifying numbers NTR627
Submission date
28/04/2006
Registration date
28/04/2006
Last edited
15/06/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Daniel Kotz
Scientific

University Maastricht (UM)
CAPHRI Research Institute
Department of General Practice
P.O. Box 616
Maastricht
6200 MD
Netherlands

+31 (0)43 3882893
d.kotz@hag.unimaas.nl

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymCOSMO
Study objectivesConfrontation with the results from spirometry as part of counselling for smoking cessation in smokers with not earlier diagnosed mild to moderate COPD is effective with regard to prolonged abstinence from smoking during a period of 12 months.
Ethics approval(s)Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studiedTobacco addiction, chronic obstructive pulmonary disease (COPD)
InterventionIntervention groups:
1. Confrontational counselling delivered by a pulmonary nurse and pharmacotherapy
2. Health education and promotion delivered by a pulmonary nurse and pharmacotherapy
3. 'Care as usual' delivered by the general practitioner
Intervention typeOther
Primary outcome measureThe primary outcome of this study is biochemically validated prolonged abstinence from smoking during a period of 12 months. A smoker is defined as prolonged abstinent if he/she is a non-smoker (no cigarette smoked during the preceding seven days), at the end of the intervention (day 50), and at the follow-up visits after 6 months (day 197) and 12 months (day 380). Non-smoking is verified by urine cotinine. Participants with a cotinine-value of >50 ng/ml are regarded as smokers as well as participants who are lost to follow-up.
Secondary outcome measures1. Point prevalence of non-smokers (no cigarette smoked during the preceding seven days) at the end of the intervention period and at 6- and 12-month follow-up
2. Self-reported number of quit attempts and temporary or complete relapse
3. Attitudes, social norms and self-efficacy with regard to smoking cessation
4. Lung function (FEV1 post-bronchodilatory and FEV1/FVC) at baseline and at 12-month follow-up
5. Anthropometry: physical height and weight at baseline, at the end of the intervention period and at 6- and 12-month follow-up
6. Perceived specific health-related complaints (impairments and functional disabilities in everyday life)
7. Health-related quality of life
8. Mental health (fear, depression)
9. Smoking related cognitions (risk perception, health concerns, self-exempting beliefs)
10. Number of unplanned visits to the general practitioner or specialized physician due to respiratory complaints and the number, severity and frequency of exacerbations (self-reported and/or reported by the general practitioner or specialist)
Overall study start date01/02/2004
Completion date01/02/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants350
Key inclusion criteria1. Age between 35 through 70 years
2. Smoker with a smoking history of >10 pack years of cigarettes
3. Motivated to stop smoking
4. One or more of the following symptoms are present: cough, progressive persistent shortness of breath (worse during exercise or respiratory infections) or sputum production
5. Bronchus obstruction detected by spirometry: FEV1/FVC-ratio <70% and postbronchodilatory FEV1 >50% predicted (= mild or moderate COPD/GOLD I or II)
6. Competent enough in speaking the Dutch language
Key exclusion criteria1. Known by the general practitioner or in the second-line medical care with the diagnosis asthma or COPD (e.g. chronic bronchitis, lung emphysema)
2. Spirometry performed during the preceding 12 months
3. FEV1 <50% predicted (= severe or very severe COPD/GOLD III or IV)
4. Contraindications for the intake of the medication such as an acute myocardial infarction and hypersensitiveness for nortriptyline
5. Current use of antidepressants
6. Quit smoking attempt(s) using nortriptyline or bupropion during the preceding 6 months
7. Co-morbidity: hypersensitiveness towards nortriptyline, tuberculosis, porfyrine, epilepsy, Parkinson's disease, glaucoma, bronchial carcinoma or any other live threatening disease
Date of first enrolment01/02/2004
Date of final enrolment01/02/2008

Locations

Countries of recruitment

  • Netherlands

Study participating centre

University Maastricht (UM)
Maastricht
6200 MD
Netherlands

Sponsor information

University Maastricht (UM), CAPHRI Research Institute (The Netherlands)
University/education

P.O. Box 616
Maastricht
6200 MD
Netherlands

+31 (0)43 3882446
e.habets@caphri.unimaas.nl
ROR logo https://ror.org/02jz4aj89

Funders

Funder type

University/education

University Hospital Maastricht (AZM) (Netherlands)

No information available

Partners in Care Solutions (PICASSO) (Netherlands)

No information available

Dutch Asthma Foundation (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/2010 Yes No
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