Clinical trial NCT05049174: Nurse-led Smoking Cessation Program With Follow-up in Healthy Life Centres: a Randomized Clinical Trial
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Smoking Cessation
Smoking Behaviors
Nurse's Role
Cardiovascular Diseases
Lead sponsor: Vestre Viken Hospital Trust
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: Oslo University Hospital
name: Norwegian Directorate of Health
name: Norwegian Institute of Public Health
First posted: 2021-09-20
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Difference between the groups in point prevalence of self-report smoking abstinence at six months follow-up
timeFrame: Six months after randomization
Secondary outcomes:
measure: Difference between the groups in proportion who quit smoking determined with objectively
timeFrame: Six months after randomization
measure: Difference between the groups in point prevalence of self-report smoking abstinence three months after randomization
timeFrame: Three months after randomization
measure: Difference between the groups in point prevalence of self-report smoking abstinence 12 months after randomization
timeFrame: Twelve months after randomization
measure: Differences in participation rate at healthy life-centres between the groups
timeFrame: 8 to 12 weeks after randomization
measure: Differences in use of smoking cessation aids between the groups
timeFrame: 8 to 12 weeks after randomization
measure: 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
timeFrame: From baseline until 2 years follow-up
measure: 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
timeFrame: From baseline until 5 years follow-up
Other outcomes:
measure: Differences in changes in clinical and psychological factors between the study groups
timeFrame: From baseline until 6 months follow-up
Locations:
city: Drammen
country: Norway
facility: Drammen Hospital
state: Viken
city: Hønefoss
country: Norway
facility: Ringerike Hospital
state: Viken
city: Kongsberg
country: Norway
facility: Kongsberg Hospital
state: Viken
Study officials:
References: