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


- candidate number15175
- NTR NumberNTR4087
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-jul-2013
- Secondary IDsREDUQ II / P13-23 / NL45791.044.13 / AF3.4.08.036 
- Public TitlePatterns and processes of cognitive and behavioural changes in patients with COPD receiving smoking reduction treatment - The REDUQ II study
- Scientific TitlePatterns and processes of cognitive and behavioural changes in patients with COPD receiving smoking reduction treatment - The REDUQ II study
- ACRONYMREDUQ II study
- hypothesis
- Healt Condition(s) or Problem(s) studiedCOPD, Smoking, Smoking cessation, Tobacco addiction, Lung emphysema, Chronic bronchitis, Nicotine dependence,
- Inclusion criteria1. Clinical COPD, GOLD stage I-IV;
2. Age 40-80 years;
3. Smoking 10 or more cigarettes daily;
4. Motivated to reduce smoking;
5. Two or more failed lifetime quit attempts (abstinence > 24 hours).
- Exclusion criteria1. Motivated to quit smoking within 1 month from baseline (= ready to quit);
2. Not able to speak, read and write Dutch;
3. Contra-indication for the use of all forms of NRT;
4. Serious psychiatric morbidity (not only depressive symptoms);
5. Pregnancy.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2013
- planned closingdate1-okt-2014
- Target number of participants32
- InterventionsParticipants of the REDUQ II study receive one of the two (experimental and control) smoking reduction treatments of the REDUQ study (see NTR2227).
- Primary outcome- (biochemically validated) smoking status
- motivation/intention to quit
- self-efficacy
- attitudes towards smoking cessation
- Secondary outcome- social influence
- desire or urge to smoke
- treatment adherence (scheduled reduced smoking)
- use of NRT and/or anti-smoking medication
- Timepoints- Baseline and 6-month follow-up
- Repeated (weekly) measures during the baseline phase (duration: 5-8 weeks), active treatment phase (duration: 13 weeks), and follow-up phase (5-8 weeks), with a total of 26 timepoints per patient.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESPhD Marcel Pieterse
- CONTACT for SCIENTIFIC QUERIESMSc. Petra Hagens
- Sponsor/Initiator Medisch Spectrum Twente, University of Twente
- Funding
(Source(s) of Monetary or Material Support)
Lung Foundation Netherlands
- PublicationsN/A
- Brief summaryThe REDUQ II study is an addendum study to the REDUQ trial (see NTR2227) and concerns a monocentre randomized single case experimental design (SCED). The study will be conducted to examine the patterns and processes of cognitive and behavioural changes in patients with COPD receiving smoking reduction treatment, offered during the REDUQ trial. The objective is to a) gain insight into the nature of the psychological processes (including cognitive as well as behavioural changes) that participants experience during the first six months of the REDUQ trial, and b) assess whether these processes are casually related to smoking cessation (attempts); and to what extent components of both interventions (intervention and control) i.e., reduction techniques, use of Nicotine Replacement Therapy (NRT), contribute to successful smoking reduction and quitting.
- Main changes (audit trail)23-12-2013: New planned closing date: 1-aug-2015 New timepoints
-Baseline and 6, 12, 18-month follow-up, and
-Repeated (weekly) measures during a baseline phase (duration: 5-8 weeks), active treatment phase (duration: 13 weeks), and follow-up phase (5-8 weeks), with a total of 26 timepoints per patient.
- RECORD23-jul-2013 - 23-dec-2013


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