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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Diseases; Smoking Cessation; Nurse's Role; Smoking Behaviors
• Intervention / Treatment: Behavioral: Nuse-led interview and referral to municipal healthy life-centres

• Study Type: Interventional
• Enrollment (Actual): 221
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Akershus
    • Drammen, Akershus, Norway, 3004
      • Drammen Hospital
    • Hønefoss, Akershus, Norway, 3511
      • Ringerike Hospital
    • Kongsberg, Akershus, Norway, 3612
      • Kongsberg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intensive intervention	Behavioral: 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
Active Comparator: Low-threshold intervention	Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference between the groups in point prevalence of self-report smoking abstinence at six months follow-up	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	Six months after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference between the groups in proportion who quit smoking determined with objectively	Difference between the groups in proportion of participants who quit smoking measured by the level of carbon monoxide in the exhaled air	Six months after randomization
Difference between the groups in point prevalence of self-report smoking abstinence 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	Three months after randomization
Difference between the groups in point prevalence of self-report smoking abstinence 12 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	Twelve months after randomization
Differences in participation rate at healthy life-centres between the groups	Differences in participation rate at healthy life-centres between the groups measured by telephone interview with personnell at the healthy life-centres	8 to 12 weeks after randomization
Differences in use of smoking cessation aids between the groups	Differences in the proportion of patients who use of smoking cessation aids (nicotine replacement therapy) between the groups measured by patient self-report	8 to 12 weeks after randomization
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	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	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, coronary revascularisation, revascularization therapy for periperial artery disease or amputation	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	From baseline until 3.5 years follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in changes in clinical and psychological factors between the study groups	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	From baseline until 6 months follow-up

Collaborators and Investigators

• Sponsor: Vestre Viken Hospital Trust
• Collaborators: University of Oslo; Norwegian Institute of Public Health; Oslo University Hospital; Norwegian Directorate of Health

Publications and helpful links

General Publications

• Getz V, Pleym K, Dammen T, Husebye E, Sverre E, Papageorgiou C, Weedon-Fekjaer H, Munkhaugen J. Clinical and psychosocial factors predicting persistent smoking in hospitalized patients with atherosclerotic vascular disease: A prespecified analysis of two randomized controlled trials. Tob Prev Cessat. 2026 Mar 13;12. doi: 10.18332/tpc/217328. eCollection 2026.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): October 31, 2024
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: September 10, 2021
• First Submitted That Met QC Criteria: September 10, 2021
• First Posted (Actual): September 20, 2021

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Health Behavior; Cardiovascular Diseases; Smoking; Smoking Cessation
• Other Study ID Numbers: 270267

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No