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ISRCTN
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ISRCTN22579361
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ClinicalTrials.gov identifier
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Public title
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A comparison of Nicotine Replacement Therapy and Nicotine Replacement Therapy combined with the Minimal Intervention Strategy for smoking cessation in cardiovascular outpatients.
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Scientific title
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Acronym
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N/A
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Serial number at source
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NHF 2000/B216
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Study hypothesis
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In the literature evidence exists that Nicotine Replacement Therapy (NRT) approximately doubles smoking cessation rates, regardless of the setting. The Minimal Intervention Strategy (MIS) is propagated by several health institutions, but its incremental effect to NRT in cardiovascular patients if performed by a nurse in an outpatient setting is not known. In this study it is hypothesised that the combination of C-MIS and NRT significantly decreases the number of smokers if compared with NRT alone.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Cardiovascular disease
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Participants - inclusion criteria
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Consecutive patients who attend the cardiological or vascular surgical outpatients clinic, have a diagnosis of atherosclerotic cardiac or arterial disease and who smoked until the cardiac event more than 5 cigarettes per day, will be included.
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Participants - exclusion criteria
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1. Acute myocardial infarction in the month prior to randomisation
2. Unstable angina
3. Serious arrhythmia
4. Recent stroke
5. Skin allergy complicating the use of nicotine patches
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Anticipated start date
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01/09/2001
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Anticipated end date
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01/05/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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365
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Interventions
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In the experimental arm: Nicotine Replacement Therapy (patches) and The Minimal Intervention Strategy (short behavioural counselling)
In the control arm: only Nicotine Replacement Therapy (patches)
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Primary outcome measure(s)
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The primary endpoint of the study is smoking cessation at 12 months follow-up, as indicated by patient self-report and objectivated by urine cotinine levels.
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Secondary outcome measure(s)
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Secondary endpoints are:
1. Changes in cognitions and smoking behaviour
2. Change in quality of life (generic and disease specific quality of life)
3. Adherence to NRT
4. Evaluation of the intervention
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Sources of funding
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The Netherlands Heart Foundation (The Netherlands) (ref: NHF2000/B216)
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Trial website
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Publications
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Results in:
1. http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=14532872
2. http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=15850883
3. http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=15917067
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Contact name
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Prof
Dink A
Legemate
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Address
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PO Box 22700
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City/town
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Amsterdam
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Zip/Postcode
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1100 DE
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Country
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Netherlands
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Tel
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+31(0)20-5667832
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Fax
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+31(0)20-5669243
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Email
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d.a.legemate@amc.uva.nl
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Sponsor
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The Netherlands Heart Foundation (The Netherlands)
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Address
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PO Box 300
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City/town
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Den Haag
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Zip/Postcode
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2501 CH
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Country
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Netherlands
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Tel
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+31 (0)70-3155514
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Fax
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+31 (0)70-3831765
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Email
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research@hartstichting.nl
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Sponsor website:
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http://www.hartstichting.nl/research
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Date applied
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29/08/2005
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Last edited
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27/09/2007
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Date ISRCTN assigned
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13/09/2005
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