Clinical trial NCT04772144: Nurse-led Smoking Cessation With Further Follow-up in Lifestyle Centres - a Randomized Pilot 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
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: Norwegian Directorate of Health
name: Oslo University Hospital
name: Norwegian Institute of Public Health
First posted: 2021-02-26
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.


Eligibility criteria: Inclusion Criteria (all):

* 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

Exclusion Criteria (none of these):

* 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)

Primary outcomes:
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
timeFrame: 8-12 weeks after randomization
measure: Differences in use of smoking cessation aids between the intervention group and the control group
timeFrame: 8-12 weeks after randomization
Secondary outcomes:
measure: Difference in point prevalence of smoke-free (no cigarettes last 7 days) after 6 months
timeFrame: 12 weeks after randomization
measure: Difference between the groups in proportion who quit smoking between the groups
timeFrame: 12 weeks after randomization
Other outcomes:
Locations:
city: Drammen
country: Norway
facility: Drammen Hospital
state: Viken
Study officials:
affiliation: Vestre Viken Trust, Drammen hospital
name: John munkhaugen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: