ISRCTN ISRCTN55212198
DOI https://doi.org/10.1186/ISRCTN55212198
Secondary identifying numbers NTR104; STIVORO and the Dutch Asthma Foundation 3.4.03.28
Submission date
12/09/2005
Registration date
12/09/2005
Last edited
10/09/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr J. Kaper
Scientific

Care and Public Health Research Institute (CAPHRI), Maastricht University
P.O. Box 616
Maastricht
6200 MD
Netherlands

Phone +31 (0)43 3882420
Email janneke.kaper@hag.unimaas.nl

Study information

Study designRandom consent design
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeOther
Scientific title(Added 18/08/09) The (cost)-effectiveness of reimbursement for smoking cessation treatment
Study objectivesReimbursement 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(s)Approved by the Medical Ethics Committee of the Trimbos Institute in Utrecht, The Netherlands (May 2005).
Health condition(s) or problem(s) studiedSmoking cessation
InterventionFor 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 typeOther
Primary outcome measureThe 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 measuresSecondary 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 study start date01/05/2002
Completion date01/05/2003

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants1,266
Key inclusion criteriaWe 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.
Key exclusion criteriaOnly one smoker per household was allowed to participate.
Date of first enrolment01/05/2002
Date of final enrolment01/05/2003

Locations

Countries of recruitment

  • Netherlands

Study participating centre

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

Sponsor information

CAPHRI research institute, University Maastricht (Netherlands)
University/education

P.O box 616
Maastricht
6200 MD
Netherlands

Website http://www.caphri.nl/
ROR logo "ROR" https://ror.org/02jz4aj89

Funders

Funder type

Charity

Dutch Asthma Foundation (Netherlands)

No information available

STIVORO (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/07/2005 Yes No
Results article results on cost effectiveness 01/07/2006 Yes No
Results article results on sustained abstinence 01/11/2006 Yes No