Effects of a reduction-to-quit smoking programme in patients with COPD: the REDUQ study.|
|- candidate number||7792|
|- NTR Number||NTR2227|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||25-feb-2010|
|- Secondary IDs||P09-22 / AF 3.4.08.036 ; MEC MST / Netherlands Asthma Foundation|
|- Public Title||Effects of a reduction-to-quit smoking programme in patients with COPD: the REDUQ study.|
|- Scientific Title||A randomised controlled trial with 18 months follow-up in COPD patients comparing a smoking reduction programme with a self-help intervention, on reduction followed by sustained cessation.|
|- ACRONYM||REDUQ study|
|- hypothesis||A reduction-to-quit smoking intervention for COPD patients, that combines behavioural counselling with nicotine replacement therapy (NRT), leads to an increase in sustained abstinence after 18 months, compared to a brief self-help smoking reduction intervention.|
|- Healt Condition(s) or Problem(s) studied||Chronic Obstructive Pulmonary Disease (COPD), Smoking cessation, Smoking, Tobacco addiction, COPD, Lung emphysema, Chronic bronchitis, Nicotine dependence, Smoking reduction|
|- Inclusion criteria||1. Clinical COPD, GOLD stage II-IV;|
2. Age 40-75 years;
3. Smoking 10 or more cigarettes daily;
4. Motivated to reduce smoking;
5. 2 failed quit attempts (abstinence > 24 hours) in the last 3 years.
|- Exclusion criteria||1. 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 NRT;
4. Serious psychiatric morbidity (not only depressive symptoms);
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jun-2010|
|- planned closingdate||1-dec-2012|
|- Target number of participants||262|
|- Interventions||Intervention arm (Reduction-to-Quit Smoking Intervention): |
Patients in the intervention group receive an intensive reduction-to-quit smoking programme, which combines behavioural counselling with nicotine replacement therapy (NRT). The programme consists of 8 group sessions (provided by pulmonary nurses) and 4 telephone contacts between meetings. NRT (nicotine patches and/or gum and/or tablets) is provided free of charge for a period of 12 weeks.
Control arm (Brief Self-Help Intervention):
Patients in the control group attend to a single information meeting on smoking reduction and cessation + receive a self-help manual.
Smoke Stop Therapy:
As soon as a patient, regardless of study group, expresses readiness to quit, he or she will be referred to the SmokeStopTherapy (SST), an intensive smoking cessation programme for COPD patients, consisting of group sessions, individual sessions and telephone consults.
|- Primary outcome||The primary outcome parameter is the percentage of patients with continuous cotinine-validated abstinence after two years from baseline, for at least the last full year.
Continuous abstinence is defined as having salivary cotinine levels < 20ng/mL at measurements at 12 and 24 months.
|- Secondary outcome||1. Smoking reduction / decrease of the daily cigarette consumption;|
2. Behavioural prognostic determinants of smoking reduction and cessation (e.g. attitude, self-efficacy, nicotine dependence);
3. Point prevalence abstinence rates at 12, 18, and 24 months;
4. Disease-specific QoL;
5. Lung function (FEV1, IVC, FEV1/IVC, FEV1% predicted);
6. Frequency and severity of exacerbations;
7. Disease-specific symptoms (breathlessness, coughing, sputum production);
8. Motivation/readiness to quit smoking;
9. Cost-effectiveness data.
|- Timepoints||Primary timepoints: Baseline, 12 and 24 months.|
Secondary timepoints: 6 and 18 months.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||PhD Marcel Pieterse|
|- CONTACT for SCIENTIFIC QUERIES||MSc. Petra Hagens|
|- Sponsor/Initiator ||University of Twente, Department of Psychology and Communication of Health and Risk (PCGR), University Medical Center Groningen (UMCG), Department of Pulmonology, Slotervaart Hospital, Catharina Hospital Eindhoven, Medisch Spectrum Twente|
(Source(s) of Monetary or Material Support)
|Netherlands Asthma Foundation|
|- Brief summary||Rationale:|
Chronic obstructive pulmonary disease (COPD) is a major cause of chronic morbidity and mortality and represents a substantial economic and social burden throughout the world. Smoking is the most common cause of COPD and smoking cessation the most effective means of favourably modifying the course of COPD. However, due to several failed quit attempts, many smoking COPD patients are convinced that they are unable to quit smoking. Other avenues to convince these patients to try again to quit smoking are therefore urgently needed. One of such strategies would be to prepare a patient for a new serious attempt by first successfully reducing the number of cigarettes smoked per day. Although total abstinence of smoking is the ultimate goal in COPD patients, sustained smoking reduction might be a valuable interlude which limits health damage until the next serious quit attempt.
The primary objective of this study is to evaluate the (cost-)effectiveness of a reduction-to-quit smoking programme, which combines behavioural counselling with nicotine replacement therapy, by comparing it to a single information meeting on smoking reduction and a self-help manual.
The REDUQ study is a multicenter, randomised, controlled (non-blinded, parallel groups) trial with 18-months follow-up in patients with COPD. Patients will be randomly assigned (1:1) to an intervention and a control group. Outcomes will be assessed at baseline, and after 6, 12, and 18 months.
262 patients with COPD (GOLD stage I-IV), 40-80 years old, currently smoking 10 cigarettes or more per day, are recruited from the outpatient departments of pulmonary medicine of five hospitals in the Netherlands. Only smoking COPD patients, who have failed at least two previous cessation attempts, and are unwilling or perceive themselves to be unable to quit smoking, but are motivated to reduce their cigarette consumption, are enrolled.
Patients in the intervention group receive an intensive reduction-to-quit smoking programme, which combines behavioural counselling and nicotine replacement therapy (NRT). It consists of eight small-group sessions, provided by pulmonary nurses, and four telephone contacts between meetings. NRT is offered free of charge for a period of 12 weeks. Patients in the control group attend to a single information meeting on smoking reduction and cessation, and receive a self-help manual with reduction strategies. As soon as patients in both groups express readiness to quit, they will be referred to an intensive smoking cessation programme.
Main study parameters/endpoints:
The primary outcome parameter is the percentage of patients with continuous cotinine-validated abstinence after 18 months, for at least the last full year. Continuous abstinence is defined as having cotinine levels < 20 ng/mL at 6, 12 and 18 months, respectively. Secondary endpoints are point prevalence abstinence rates and sustained reduced smoking at 6, 12 and 18 months. Other outcomes are disease specific quality of life, motivation/readiness to quit smoking, lung function, and exacerbations defined as needing treatment with a course of oral steroids or antibiotics. Finally, the use of health-care services is evaluated to enable a cost-effectiveness analysis.
Country of recruitment: the Netherlands.
|- Main changes (audit trail)||8-May-2010: Start- and enddate postponed for a month - NM|
26-Jul-2010: MEC-approval received on 29-Jun-2010 - NM
26-Jul-2011: Withdrawal of the Isala Clinics as sponsor - NM
03-May-2013: Planned closingdate delayed to 15-Jan-2014 - NM
29-apr-2017: Changes approved by MEC at mentioned dates, only now added to the NTR. -EB
08-11-2011 (date of MEC approval for amendment):
Change in follow-up from 24 months to 18 months and corresponding change in time points (6, 12 and 18 months instead of 12 and 24 months).
Change inclusion criterion “Clinical COPD, GOLD stage II-IV” into COPD, GOLD stage I-IV”.
Change inclusion criterion “Age 40 – 75 years” into “Age 40-80 years)
08-07-2013 (date of MEC approval for amendment): Change inclusion criterion “2 failed quit attempts (abstinence > 24 hours) in the last 3 years” into “2 failed lifetime quit attempts (abstinence > 24 hours).
Planned closing date delayed to 1 January 2016
|- RECORD||25-feb-2010 - 29-apr-2017|
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