Smoking CessationNCT04772144
Nurse-led Smoking Cessation With Further Follow-up in Lifestyle Centres - a Randomized Pilot Study
A study testing behavioural and cessation aids in people with Smoking Cessation and Smoking Behaviors, run by Vestre Viken Hospital Trust at 1 site in Norway.
Trial summary
The purpose of this randomized controlled pilot study is to test whether an in-hospital nurse-led smoking cessation intervention increases the refferal rate to healty life-centers in the municipalities. 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?
- behavioural and cessation aids
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteNorway
- Study dates
- 25 Feb 2021to 1 Jun 2022
- 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 a cardiovascular event (i.e. myocardial infarction, heart failure, unstable or stable angina, achyarrhythmias, bradyarrhythmias, carotid stenosis or claudication with need for peripheral revascularization)
- Sign informed consent and is expected to participate according to ICH / GCP
Who cannot join
- Does not meet the criteria to participate in the pilot project, i.e. patients who do not usually live or work in the Vestre Viken catchment area
- Chronic renal failure stage 4 or known allergic reaction to varenicline
- . 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
1 site in 1 country.
About this study
Official title: Smoking Cessation After a Cardiovascular Disease Event With Hospital-based Nurse-coordination and Further Follow-up Care in Lifestyle Centres With Free Cessation Aids - an Interdisciplinary Randomized Pilot Study
The purpose of this randomized controlled pilot study is to test whether an in-hospital nurse-led smoking cessation intervention increases the refferal rate to healty life-centers in the municipalities. We will also describe the proportion who succeed in quitting smoking between the intervention group and the control group and obtain new knowledge about the patient and system factors of importance for participation to healty life-centers and for successful and unsuccessful smoking cessation.
- Being tested
- behavioural and cessation aids
- 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.
behavioural and cessation aidsBehavioural
information, motivational interview, refferal to healty life-centers, free cessation aids
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Behavioral: behavioural and cessation aids |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in participation rate at healthy life-centers between the intervention group and the control group measured by telephone interview with personnell at the healthy life-centers
Differences in participation rate at healthy life-centers between the intervention group and the control group measured by telephone interview with personnell at the healthy life-centers
Measured: 8-12 weeks after randomization
Differences in use of smoking cessation aids between the intervention group and the control group
Differences in use of smoking cessation aids between the intervention group and the control group measued by patient self-report and collected from the prescription mediator in the hospital record
Measured: 8-12 weeks after randomization
Secondary outcomes (2)
Difference in point prevalence of smoke-free (no cigarettes last 7 days) after 6 months
Difference in point prevalence of smoke-free (no cigarettes last 7 days) after 6 months measured with self-reported questionnaires according to the Russell Standard
Measured: 12 weeks after randomization
Difference between the groups in proportion who quit smoking between the groups
Difference between the groups in proportion who quit smoking between the groups measured by the level of carbon monoxide in the exhaled air
Measured: 12 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start25 Feb 2021
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
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
- patients were randomized to an in-hospital nurse-led smoking cessation intervention with prescription of free cessation aids and systematic referrral to healthy life-centeres or usual care
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vestre Viken Hospital Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, Norwegian Directorate of Health, Oslo University Hospital, Norwegian Institute of Public Health
- Responsible party
- Sponsor
- Investigators
- John munkhaugen, MD, PhD, Principal investigator, Vestre Viken Trust, Drammen hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772144
- Sponsor's protocol ID
- REK 202686
- Status last verified
- Oct 2022
- First submitted
- 7 Jan 2021
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Cessation After a Cardiovascular Disease Event With Hospital-based Nurse-coordination and Further Follow-up Care in Lifestyle Centres With Free Cessation Aids - an Interdisciplinary Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT04772144
- Acronym / sponsor ID
- REK 202686
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Vestre Viken Hospital TrustUniversity, hospital or other
- Collaborators
- University of Oslo, Norwegian Directorate of Health, Oslo University Hospital, Norwegian Institute of Public Health
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 26 Feb 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.
The purpose of this randomized controlled pilot study is to test whether an in-hospital nurse-led smoking cessation intervention increases the refferal rate to healty life-centers in the municipalities. We will also describe the proportion who succeed in quitting smoking between the intervention group and the control group and obtain new knowledge about the patient and system factors of importance for participation to healty life-centers and for successful and unsuccessful smoking cessation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- patients were randomized to an in-hospital nurse-led smoking cessation intervention with prescription of free cessation aids and systematic referrral to healthy life-centeres or usual care
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: behavioural and cessation aids |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age> 18 years and smokes at least 1 cigarette daily
- Hospitalized with a cardiovascular event (i.e. myocardial infarction, heart failure, unstable or stable angina, achyarrhythmias, bradyarrhythmias, carotid stenosis or claudication with need for peripheral revascularization)
- Sign informed consent and is expected to participate according to ICH / GCP
Key exclusion criteria (5 listed)
- Does not meet the criteria to participate in the pilot project, i.e. patients who do not usually live or work in the Vestre Viken catchment area
- Chronic renal failure stage 4 or known allergic reaction to varenicline
- . 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 |
|---|---|---|
| behavioural and cessation aidsinformation, motivational interview, refferal to healty life-centers, free cessation aids | Behavioural | Intervention group |
Primary outcome
Differences in participation rate at healthy life-centers between the intervention group and the control group measured by telephone interview with personnell at the healthy life-centers
Time frame: 8-12 weeks after randomization
Differences in participation rate at healthy life-centers between the intervention group and the control group measured by telephone interview with personnell at the healthy life-centers
Differences in use of smoking cessation aids between the intervention group and the control group
Time frame: 8-12 weeks after randomization
Differences in use of smoking cessation aids between the intervention group and the control group measued by patient self-report and collected from the prescription mediator in the hospital record
2 secondary outcomes
Difference in point prevalence of smoke-free (no cigarettes last 7 days) after 6 months
Time frame: 12 weeks after randomization
Difference between the groups in proportion who quit smoking between the groups
Time frame: 12 weeks after randomization
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 18 Oct 2022.
- 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.
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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.
John munkhaugen, MD, PhD principal investigator
Vestre Viken Trust, Drammen hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing behavioural and cessation aids in people with Smoking Cessation and Smoking Behaviors, run by Vestre Viken Hospital Trust at 1 site 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 3 inclusion and 5 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 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Differences in participation rate at healthy life-centers between the intervention group and the control group measured by telephone interview with personnell at the healthy life-centers (time frame: 8-12 weeks after randomization). The study lists 2 primary outcomes in all. 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 NCT04772144, 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 18 Oct 2022.