Smoking CessationNCT05049174
Nurse-led Smoking Cessation Program With Follow-up in Healthy Life Centres: a Randomized Clinical Trial
A study testing Nuse-led interview and referral to municipal healthy life-centres in people with Smoking Cessation and Smoking Behaviors, run by Vestre Viken Hospital Trust at 3 sites in Norway.
Trial summary
A better understanding of how to incorporate effective smoking cessation measures into clinical practice is requested. In this is prospective, multi-center, randomized, open, blinded end-point (PROBE) trial, we assigned daily smokers hospitalized with an acute cardiac event 1:1 to an in-hospital nurse-led smoking… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, Smoking Behaviors, Nurse's Role
- What is being tested?
- Nuse-led interview and referral to municipal healthy life-centres
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 3 sitesNorway
- Study dates
- 1 Nov 2021to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age> 18 years and smokes at least 1 cigarette daily
- Hospitalized with an acute cardiovascular event (i.e. myocardial infarction, unstable or stable angina, arrythmias, stroke, transitory ischemic attac, carotid stenosis or claudication with need for revascularization)
- established atheroscledrotic cardiovascular disease
- Sign informed consent and is expected to participate according to ICH /GCP
Who cannot join
- Does not usually live or work in the Vestre Viken catchment area
- Any condition (e.g. psychosis, alcohol abuse, dementia) or situation that may pose a significant risk to the participant, confuse the results or make participation unethical
- Lack of Norwegian and English knowledge
- Short life expectancy (<12 months)
Trial locations and contacts
3 sites in 1 country.
Norway3 sites
Drammen Hospital
Drammen, Akershus, 3004
Ringerike Hospital
Hønefoss, Akershus, 3511
Kongsberg Hospital
Kongsberg, Akershus, 3612
About this study
Official title: Clinical and Health-economic Effects of a Nurse-led Smoking Cessation Program With Follow-up in Healthy Life Centres With Free Cessation Drugs: a Randomized Clinical Trial
A better understanding of how to incorporate effective smoking cessation measures into clinical practice is requested. In this is prospective, multi-center, randomized, open, blinded end-point (PROBE) trial, we assigned daily smokers hospitalized with an acute cardiac event 1:1 to an in-hospital nurse-led smoking cessation intervention with direct referral to further follow-up in the municipal healthy life-centres (intensive intervention) or to written information about smoking cessation and the municipal program (low-threshold intervention) . The primary outcome will be the smoking cessation rates between the groups at 6 months follow-up. Key secondary outcomes include a cost-effectiveness analysis of the intensive intervention and cessation rates at 3- and 12-months follow-up, the proportion who used nicotine replacement therapy and the proportion who attended the healthy-life center program between the two groups. We also assess effects of recurrent cardiovascular events and mortality after 12 months, two and five years follow-up. Exploratory analyses include new knowledge about the patient and system factors of importance for participation to healthy life-centers and for changes in smoking behaviour.
- Being tested
- Nuse-led interview and referral to municipal healthy life-centres
- Medical subject headings
- Smoking Cessation, Smoking, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nuse-led interview and referral to municipal healthy life-centresBehavioural
Usual care treatment and written information to patients and general practitionnaires about smoking cessation and the municipal healthy life-centres
| Study group | Role | What they receive |
|---|---|---|
| Intensive intervention | Experimental | Not described Receives: Behavioral: Nuse-led interview and referral to municipal healthy life-centres |
| Low-threshold intervention | Active comparator | Not described Receives: Behavioral: Nuse-led interview and referral to municipal healthy life-centres |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between the groups in point prevalence of self-report smoking abstinence at six months follow-up
Difference between the groups in the proportion of participants who self-report smoking abstinence over the whole follow-up period at six months follow-up allowing up to five cigarettes in total
Measured: Six months after randomization
Secondary outcomes (7)
Difference between the groups in proportion who quit smoking determined with objectively
Difference between the groups in proportion of participants who quit smoking measured by the level of carbon monoxide in the exhaled air
Measured: Six months after randomization
Difference between the groups in point prevalence of self-report smoking abstinence three months after randomization
Difference between the groups in the proportion of participants who self-report smoking abstinence over the whole periode follow-up period at six months follow-up allowing up to five cigarettes in total
Measured: Three months after randomization
Difference between the groups in point prevalence of self-report smoking abstinence 12 months after randomization
Difference between the groups in the proportion of participants who self-report smoking abstinence over the whole periode follow-up period at six months follow-up allowing up to five cigarettes in total
Measured: Twelve months after randomization
Differences in participation rate at healthy life-centres between the groups
Differences in participation rate at healthy life-centres between the groups measured by telephone interview with personnell at the healthy life-centres
Measured: 8 to 12 weeks after randomization
Differences in use of smoking cessation aids between the groups
Differences in the proportion of patients who use of smoking cessation aids (nicotine replacement therapy) between the groups measured by patient self-report
Measured: 8 to 12 weeks after randomization
Difference between the groups in the composite end-point all-cause mortality, hospitalisation for myocardial infarction, stroke, transitrory ischemic attac, coronary revascularisation or symptomatic periperial artery disease
Difference between the groups in the composite end-point all-cause mortality, hospitalisation for myocardial infarction, stroke, transitrory ischemic attac, coronary revascularisation or symptomatic periperial artery disease obtained from hospital medical records
Measured: From baseline until 1.5 years follow-up
Difference between the groups in the composite end-point all-cause mortality, hospitalisation for myocardial infarction, stroke, coronary revascularisation, revascularization therapy for periperial artery disease or amputation
Difference between the groups in the composite end-point all-cause mortality, hospitalisation for myocardial infarction, stroke, coronary revascularisation, revascularization therapy for periperial artery disease or amputation obtained from hospital medical records
Measured: From baseline until 3.5 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start1 Nov 2021
- Primary completion31 Oct 2024
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized 1:1 to an in-hospital nurse-led smoking cessation intervention with systematic referrral to the municipal healthy life-centres or to written information about smoking cessation and the municipal health service program.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vestre Viken Hospital Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, Oslo University Hospital, Norwegian Directorate of Health, Norwegian Institute of Public Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05049174
- Sponsor's protocol ID
- 270267
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2021
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Getz V, Pleym K, Dammen T, Husebye E, Sverre E, Papageorgiou C, Weedon-Fekjaer H, Munkhaugen J. Clinical and psychosocial factors predicting persistent smoking in hospitalized patients with atherosclerotic vascular disease: A prespecified analysis of two randomized controlled trials. Tob Prev Cessat. 2026 Mar 13;12. doi: 10.18332/tpc/217328. eCollection 2026.
PubMed 41869372
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Health-economic Effects of a Nurse-led Smoking Cessation Program With Follow-up in Healthy Life Centres With Free Cessation Drugs: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05049174
- Acronym / sponsor ID
- 270267
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Vestre Viken Hospital TrustUniversity, hospital or other
- Collaborators
- University of Oslo, Oslo University Hospital, Norwegian Directorate of Health, Norwegian Institute of Public Health
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 20 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A better understanding of how to incorporate effective smoking cessation measures into clinical practice is requested. In this is prospective, multi-center, randomized, open, blinded end-point (PROBE) trial, we assigned daily smokers hospitalized with an acute cardiac event 1:1 to an in-hospital nurse-led smoking cessation intervention with direct referral to further follow-up in the municipal healthy life-centres (intensive intervention) or to written information about smoking cessation and the municipal program (low-threshold intervention) . The primary outcome will be the smoking cessation rates between the groups at 6 months follow-up. Key secondary outcomes include a cost-effectiveness analysis of the intensive intervention and cessation rates at 3- and 12-months follow-up, the proportion who used nicotine replacement therapy and the proportion who attended the healthy-life center program between the two groups. We also assess effects of recurrent cardiovascular events and mortality after 12 months, two and five years follow-up. Exploratory analyses include new knowledge about the patient and system factors of importance for participation to healthy life-centers and for changes in smoking behaviour.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomized 1:1 to an in-hospital nurse-led smoking cessation intervention with systematic referrral to the municipal healthy life-centres or to written information about smoking cessation and the municipal health service program.
| Arm | Type | Receives |
|---|---|---|
| Intensive intervention | Experimental | Behavioral: Nuse-led interview and referral to municipal healthy life-centres |
| Low-threshold intervention | Active comparator | Behavioral: Nuse-led interview and referral to municipal healthy life-centres |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age> 18 years and smokes at least 1 cigarette daily
- Hospitalized with an acute cardiovascular event (i.e. myocardial infarction, unstable or stable angina, arrythmias, stroke, transitory ischemic attac, carotid stenosis or claudication with need for revascularization)
- established atheroscledrotic cardiovascular disease
- Sign informed consent and is expected to participate according to ICH /GCP
Key exclusion criteria (4 listed)
- Does not usually live or work in the Vestre Viken catchment area
- Any condition (e.g. psychosis, alcohol abuse, dementia) or situation that may pose a significant risk to the participant, confuse the results or make participation unethical
- Lack of Norwegian and English knowledge
- Short life expectancy (<12 months)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nuse-led interview and referral to municipal healthy life-centresUsual care treatment and written information to patients and general practitionnaires about smoking cessation and the municipal healthy life-centres | Behavioural | Intensive intervention, Low-threshold intervention |
Primary outcome
Difference between the groups in point prevalence of self-report smoking abstinence at six months follow-up
Time frame: Six months after randomization
Difference between the groups in the proportion of participants who self-report smoking abstinence over the whole follow-up period at six months follow-up allowing up to five cigarettes in total
7 secondary outcomes
Difference between the groups in proportion who quit smoking determined with objectively
Time frame: Six months after randomization
Difference between the groups in point prevalence of self-report smoking abstinence three months after randomization
Time frame: Three months after randomization
Difference between the groups in point prevalence of self-report smoking abstinence 12 months after randomization
Time frame: Twelve months after randomization
Differences in participation rate at healthy life-centres between the groups
Time frame: 8 to 12 weeks after randomization
Differences in use of smoking cessation aids between the groups
Time frame: 8 to 12 weeks after randomization
Difference between the groups in the composite end-point all-cause mortality, hospitalisation for myocardial infarction, stroke, transitrory ischemic attac, coronary revascularisation or symptomatic periperial artery disease
Time frame: From baseline until 1.5 years follow-up
Difference between the groups in the composite end-point all-cause mortality, hospitalisation for myocardial infarction, stroke, coronary revascularisation, revascularization therapy for periperial artery disease or amputation
Time frame: From baseline until 3.5 years follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Derived from this study: PubMed 41869372Getz V, Pleym K, Dammen T, Husebye E, Sverre E, Papageorgiou C, Weedon-Fekjaer H, Munkhaugen J. Clinical and psychosocial factors predicting persistent smoking in hospitalized patients with atherosclerotic vascular disease: A prespecified analysis of two randomized controlled trials. Tob Prev Cessat. 2026 Mar 13;12. doi: 10.18332/tpc/217328. eCollection 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nuse-led interview and referral to municipal healthy life-centres in people with Smoking Cessation and Smoking Behaviors, run by Vestre Viken Hospital Trust at 3 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between the groups in point prevalence of self-report smoking abstinence at six months follow-up (time frame: Six months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05049174, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.