Nurse-led Smoking Cessation Program With Follow-up in Healthy Life Centres: a Randomized Clinical Trial

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

221 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2024-04-30

Brief Summary

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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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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

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intensive intervention

Group Type EXPERIMENTAL

Nuse-led interview and referral to municipal healthy life-centres

Intervention Type BEHAVIORAL

Usual care treatment and written information to patients and general practitionnaires about smoking cessation and the municipal healthy life-centres

Low-threshold intervention

Group Type ACTIVE_COMPARATOR

Nuse-led interview and referral to municipal healthy life-centres

Intervention Type BEHAVIORAL

Usual care treatment and written information to patients and general practitionnaires about smoking cessation and the municipal healthy life-centres

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No