Patterns and processes of cognitive and behavioural changes in patients with COPD receiving smoking reduction treatment - The REDUQ II study

Completed

Conditions: nicotineafhankelijkheid/ tabaksverslaving/rookverslaving
COPD (smoker's lung)
tobacco addiction
10037454

Registration Number: NL-OMON41681

Lead Sponsor: niversiteit Twente

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 32

Inclusion Criteria

Clinical diagnosis of COPD (GOLD criteria stage I-IV);
Currently smoking 10 or more cigarettes per day;
Age between 40 and 80 years;
Two or more failed lifetime quit attempts (abstinentie > 24 hours);
Motivated to reduce the number of cigarettes smoked.

Exclusion Criteria

Motivated to quit smoking 1 month from baseline (= ready to quit);
Not able to speak, read and write Dutch;
Contra-indication for the use of all forms of Nicotine Replacement Therapy (NRT);
Serious psychiatric morbidity (not only depressive symptoms);
Pregnancy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter of the RCT is continuous abstinence (cotinine<br /><br>validated) after 18 months, for at least the last full year (also see REDUQ<br /><br>protocol P09-22)<br /><br><br /><br>The main study parameters of the SCED are factors addressed in the smoking<br /><br>reduction intervention: smoking behaviour (change) and (psychological) factors<br /><br>thought to be predictive of behaviour change. The study parameters are (changes<br /><br>in):<br /><br>• Smoking status<br /><br>• Motivation/Intention to quit<br /><br>• Self-efficacy<br /><br>• Attitudes towards smoking cessation</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters of the RCT are (also see REDUQ protocol P09-22):<br /><br>- point prevalence abstinence rates<br /><br>- sustained reduced smoking at 6, 12, and 18 monhts<br /><br>- disease specific quality of life<br /><br>- lung function (FEV1)<br /><br>- anxiety and depression<br /><br>- nicotine dependence<br /><br>- exacerbations defined as needing treatment with a course of oral steroids or<br /><br>antibiotocs<br /><br>- use of health care services ( to enable a cost-effectiveness analysis)<br /><br><br /><br>Secondary parameters of the SCED are:<br /><br>- Social influence<br /><br>- Desire or urge to smoke<br /><br>- Treatment adherence (scheduled reduced smoking)<br /><br>- Use of NRT and/or anti-smoking medication</p><br>