Nurse-led Smoking Cessation Program With Follow-up in Healthy Life Centres: a Randomized Clinical Trial
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ClinicalTrials.gov Identifier: NCT05049174 |
Recruitment Status :
Recruiting
First Posted : September 20, 2021
Last Update Posted : October 19, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Smoking Cessation Smoking Behaviors Nurse's Role Cardiovascular Diseases | Behavioral: Nuse-led interview and referral to municipal healthy life-centres | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 220 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention 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 (Outcomes Assessor) |
Primary Purpose: | Health Services Research |
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 |
Actual Study Start Date : | November 1, 2021 |
Estimated Primary Completion Date : | February 15, 2024 |
Estimated Study Completion Date : | February 15, 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: Intensive intervention |
Behavioral: Nuse-led interview and referral to municipal healthy life-centres
Usual care treatment and written information to patients and general practitionnaires about smoking cessation and the municipal healthy life-centres |
Active Comparator: Low-threshold intervention |
Behavioral: Nuse-led interview and referral to municipal healthy life-centres
Usual care treatment and written information to patients and general practitionnaires about smoking cessation and the municipal healthy life-centres |
- 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
- Difference between the groups in proportion who quit smoking determined with objectively [ Time Frame: Six months after randomization ]Difference between the groups in proportion of participants who quit smoking measured by the level of carbon monoxide in the exhaled air
- 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 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
- Difference between the groups in point prevalence of self-report smoking abstinence 12 months after randomization [ Time Frame: Twelve 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
- Differences in participation rate at healthy life-centres between the groups [ Time Frame: 8 to 12 weeks after randomization ]Differences in participation rate at healthy life-centres between the groups measured by telephone interview with personnell at the healthy life-centres
- Differences in use of smoking cessation aids between the groups [ Time Frame: 8 to 12 weeks after randomization ]Differences in the proportion of patients who use of smoking cessation aids (nicotine replacement therapy) between the groups measured by patient self-report
- 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 12 months follow-up ]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
- 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 2 years follow-up ]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
- 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 5 years follow-up ]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
- Differences in changes in clinical and psychological factors between the study groups [ Time Frame: From baseline until 6 months follow-up ]Differences between the study groups in the proportion of participants who report significant changes in clinical and psychological factors from baseline until six months follow-up measured by patient self-report

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05049174
Contact: John Munkhaugen, MD, PhD | +47 97524194 | johmun@vestreviken.no | |
Contact: Elise Sverre, MD, PhD | +47 99020329 | elisbj@vestreviken.no |
Norway | |
Drammen Hospital | Recruiting |
Drammen, Viken, Norway, 3004 | |
Contact: John Munkhaugen, MD, PhD +4797524194 johmun@vestreviken.no | |
Contact: Elise Sverre, MD, PhD +4799020329 elisbj@vestreviken.no | |
Ringerike Hospital | Recruiting |
Hønefoss, Viken, Norway, 3511 | |
Contact: Marie Stugaard, MD, PhD | |
Kongsberg Hospital | Recruiting |
Kongsberg, Viken, Norway, 3612 | |
Contact: Mohpal Kahlon, MD |
Responsible Party: | Vestre Viken Hospital Trust |
ClinicalTrials.gov Identifier: | NCT05049174 |
Other Study ID Numbers: |
270267 |
First Posted: | September 20, 2021 Key Record Dates |
Last Update Posted: | October 19, 2022 |
Last Verified: | October 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Cardiovascular Diseases |