None listed
Conditions
Interventions
2. Health education and promotion delivered by a pulmonary nurse and pharmacotherapy
or
3. "Care as usual" delivered by the general practitioner.
Intervention groups:
1. Confrontational counselling delivered by a pulmonary nurse and pharmacotherapy
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 1. 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 50% predicted (= mild or moderate COPD / GOLD I or II); 6. Competent enough in speaking the Dutch language.
Exclusion criteria
Exclusion criteria: 1. Known by the general practitioner or in the second-line medical care with the diagnosis asthma or COPD (c.q. 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 disease, glaucoma, bronchial carcinoma or any other live threatening disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The 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 > 50ng/mL are regarded as smokers as well as participants who are lost to follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 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). | — |
Contacts
Public ContactDaniel Kotz
University Maastricht (UM), CAPHRI Research Institute, Department of General Practice, P.O. Box 616
Outcome results
None listed