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| Name | Class |
|---|---|
| University of Oslo | OTHER |
| Oslo University Hospital | OTHER |
| Norwegian Directorate of Health | OTHER_GOV |
| Norwegian Institute of Public Health |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive intervention | Experimental |
| |
| Low-threshold intervention | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nuse-led interview and referral to municipal healthy life-centres | Behavioral | Usual care treatment and written information to patients and general practitionnaires about smoking cessation and the municipal healthy life-centres |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Six months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Six months after randomization |
| Difference between the groups in point prevalence of self-report smoking abstinence three months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in changes in clinical and psychological factors between the study groups | 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 | From baseline until 6 months follow-up |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Drammen Hospital | Drammen | Akershus | 3004 | Norway | ||
| Ringerike Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41869372 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | May 6, 2026 | May 7, 2026 |
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| OTHER_GOV |
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.
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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 |
| 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 | 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 | 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 | 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 | 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 | From baseline until 3.5 years follow-up |
| Hønefoss |
| Akershus |
| 3511 |
| Norway |
| Kongsberg Hospital | Kongsberg | Akershus | 3612 | Norway |
| SAP_002.pdf |
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D012907 | Smoking |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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