Nurse-led Smoking Cessation With Further Follow-up in Lifestyle Centres - a Randomized Pilot Study

NCT ID: NCT04772144

Last Updated: 2022-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-25

Study Completion Date

2022-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Smoking Cessation Smoking Behaviors Nurse's Role Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention group

Group Type EXPERIMENTAL

behavioural and cessation aids

Intervention Type BEHAVIORAL

information, motivational interview, refferal to healty life-centers, free cessation aids

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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behavioural and cessation aids

information, motivational interview, refferal to healty life-centers, free cessation aids

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oslo

OTHER

Sponsor Role collaborator

Norwegian Directorate of Health

OTHER_GOV

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role collaborator

Norwegian Institute of Public Health

OTHER_GOV

Sponsor Role collaborator

Vestre Viken Hospital Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John munkhaugen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Vestre Viken Trust, Drammen hospital

Locations

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Drammen Hospital

Drammen, Akershus, Norway

Site Status

Countries

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Norway

Other Identifiers

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REK 202686

Identifier Type: -

Identifier Source: org_study_id

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