Condition category
Circulatory System
Date applied
29/08/2005
Date assigned
13/09/2005
Last edited
27/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.hartstichting.nl/research

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes