Contact information
Type
Scientific
Primary contact
Prof Dink A Legemate
ORCID ID
Contact details
PO Box 22700
Amsterdam
1100 DE
Netherlands
+31(0)20-5667832
d.a.legemate@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NHF 2000/B216
Study information
Scientific title
Acronym
Study hypothesis
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Cardiovascular disease
Intervention
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)
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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.
Secondary outcome measures
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
Overall trial start date
01/09/2001
Overall trial end date
01/05/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
365
Participant exclusion criteria
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
Recruitment start date
01/09/2001
Recruitment end date
01/05/2004
Locations
Countries of recruitment
Netherlands
Trial participating centre
PO Box 22700
Amsterdam
1100 DE
Netherlands
Sponsor information
Organisation
The Netherlands Heart Foundation (The Netherlands)
Sponsor details
PO Box 300
Den Haag
2501 CH
Netherlands
+31 (0)70-3155514
research@hartstichting.nl
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
The Netherlands Heart Foundation (The Netherlands) (ref: NHF2000/B216)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
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
Publication citations
-
Wiggers LC, Smets EM, de Haes JC, Peters RJ, Legemate DA, Smoking cessation interventions in cardiovascular patients., Eur J Vasc Endovasc Surg, 2003, 26, 5, 467-475.
-
Wiggers LC, Oort FJ, Dijkstra A, de Haes JC, Legemate DA, Smets EM, Cognitive changes in cardiovascular patients following a tailored behavioral smoking cessation intervention., Prev Med, 2005, 40, 6, 812-821, doi: 10.1016/j.ypmed.2004.09.028.
-
Wiggers LC, Stalmeier PF, Oort FJ, Smets EM, Legemate DA, de Haes JC, Do patients' preferences predict smoking cessation?, Prev Med, 2005, 41, 2, 667-675, doi: 10.1016/j.ypmed.2004.12.009.