Condition category
Mental and Behavioural Disorders
Date applied
12/09/2005
Date assigned
12/09/2005
Last edited
10/09/2009
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

Dr J. Kaper

ORCID ID

Contact details

Care and Public Health Research Institute (CAPHRI)
Maastricht University
P.O. Box 616
Maastricht
6200 MD
Netherlands
+31 (0)43 3882420
janneke.kaper@hag.unimaas.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR104; STIVORO and the Dutch Asthma Foundation 3.4.03.28

Study information

Scientific title

(Added 18/08/09) The (cost)-effectiveness of reimbursement for smoking cessation treatment

Acronym

Study hypothesis

Reimbursement for smoking cessation treatment will increase the use of the treatment and the number of quit attempts. The increased use of smoking cessation treatment by reimbursement will result into increased prolonged abstinence.

Ethics approval

Approved by the Medical Ethics Committee of the Trimbos Institute in Utrecht, The Netherlands (May 2005).

Study design

Random consent design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

Condition

Smoking cessation

Intervention

For a period of 6 months, smokers in the intervention group had the opportunity to apply for reimbursement for SCT. They received a leaflet with a description of the SCTs for which reimbursement was available, and information on how to receive the reimbursement. Smokers in the intervention group could receive full reimbursement for pharmacological treatment (bupropion and NRT (chewing gum, patch, tablet, sublingual tablet and inhaler)), behavioural counselling (written advice, telephone or face to face counselling) or a combination. To receive reimbursement, they had to send the receipt and two statements of personal contact with a health care professional (general practitioner, general practice nurse, physician, psychologist or health community worker) to the health insurance company. Before the study started, all the health care professionals in the study region were informed about the study. No limit was set on the number of applications for reimbursement. In the control, no reimbursement or information about smoking cessation treatment was offered.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The primary outcome measure of the reimbursement study was continuous abstinence from smoking. Continuous abstinence was defined as not having smoked for at least seven days preceding the 6-month and 12-month questionnaire and not having relapsed between both questionnaires. After the 6-month and 12-month questionnaire, quitters were contacted to make an appointment for biochemical validation of their smoking status.

Secondary outcome measures

Secondary outcomes were the use of smoking cessation treatment, the number of quit attempts that were undertaken, and the cost-effectiveness of reimbursement was assessed.

Overall trial start date

01/05/2002

Overall trial end date

01/05/2003

Reason abandoned

Eligibility

Participant inclusion criteria

We included smokers of at least 18 years old and healthcare insured by health insurance company "De Friesland Zorgverzekeraar". Participants did not have to be motivated to quit smoking.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1,266

Participant exclusion criteria

Only one smoker per household was allowed to participate.

Recruitment start date

01/05/2002

Recruitment end date

01/05/2003

Locations

Countries of recruitment

Netherlands

Trial participating centre

Care and Public Health Research Institute (CAPHRI), Maastricht University
Maastricht
6200 MD
Netherlands

Sponsor information

Organisation

CAPHRI research institute, University Maastricht (Netherlands)

Sponsor details

P.O box 616
Maastricht
6200 MD
Netherlands

Sponsor type

University/education

Website

http://www.caphri.nl/

Funders

Funder type

Charity

Funder name

Dutch Asthma Foundation (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

STIVORO (Netherlands)

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

1. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15955017
2. 2006 results on cost effectiveness in http://www.ncbi.nlm.nih.gov/pubmed/16706571
3. 2006 results on sustained abstinence in http://www.ncbi.nlm.nih.gov/pubmed/17034446

Publication citations

  1. Results

    Kaper J, Wagena EJ, Willemsen MC, van Schayck CP, Reimbursement for smoking cessation treatment may double the abstinence rate: results of a randomized trial., Addiction, 2005, 100, 7, 1012-1020, doi: 10.1111/j.1360-0443.2005.01097.x.

  2. Results on cost effectiveness

    Kaper J, Wagena EJ, van Schayck CP, Severens JL, Encouraging smokers to quit: the cost effectiveness of reimbursing the costs of smoking cessation treatment., Pharmacoeconomics, 2006, 24, 5, 453-464.

  3. Results on sustained abstinence

    Kaper J, Wagena EJ, Willemsen MC, van Schayck CP, A randomized controlled trial to assess the effects of reimbursing the costs of smoking cessation therapy on sustained abstinence., Addiction, 2006, 101, 11, 1656-1661, doi: 10.1111/j.1360-0443.2006.01578.x.

Additional files

Editorial Notes