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NCT Number: NCT05049174

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Smoking Cessation Behavior Cardiovascular Diseases Health Behavior Nurse's Role Smoking Smoking Behaviors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Drammen Hospital, Drammen, Akershus, Norway

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. Difference between the groups in point prevalence of self-report smoking abstinence at six months follow-up

    Time frame: Six months after randomization

    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

Secondary outcomes

  1. Difference between the groups in proportion who quit smoking determined with objectively

    Time frame: Six months after randomization

    Difference between the groups in proportion of participants who quit smoking measured by the level of carbon monoxide in the exhaled air

  2. Difference between the groups in point prevalence of self-report smoking abstinence three months after randomization

    Time frame: Three 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

  3. Difference between the groups in point prevalence of self-report smoking abstinence 12 months after randomization

    Time frame: Twelve 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

  4. Differences in participation rate at healthy life-centres between the groups

    Time frame: 8 to 12 weeks after randomization

    Differences in participation rate at healthy life-centres between the groups measured by telephone interview with personnell at the healthy life-centres

  5. Differences in use of smoking cessation aids between the groups

    Time frame: 8 to 12 weeks after randomization

    Differences in the proportion of patients who use of smoking cessation aids (nicotine replacement therapy) between the groups measured by patient self-report

  6. 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

    Time frame: 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, transitrory ischemic attac, coronary revascularisation or symptomatic periperial artery disease obtained from hospital medical records

  7. 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

    Time frame: From baseline until 3.5 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 obtained from hospital medical records

Other outcomes

  1. Differences in changes in clinical and psychological factors between the study groups

    Time frame: From baseline until 6 months follow-up

    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

Sponsors and collaborators

Lead sponsor

Vestre Viken Hospital Trust

Other

Collaborators

  • Norwegian Directorate of Health
  • Norwegian Institute of Public Health
  • Oslo University Hospital
  • University of Oslo

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Sep 20, 2021
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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