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.

NCT Number	NCT05049174
Lead Sponsor	Vestre Viken Hospital Trust Collaborators: University of Oslo, Oslo University Hospital, Norwegian Directorate of Health, Norwegian Institute of Public Health
Conditions	Smoking Cessation, Smoking Behaviors, Nurse's Role, Cardiovascular Diseases
Enrollment	221 participants
Start Date	2021-11-01
Primary Completion	2024-10-31 (estimated)
Study Completion	2026-08-01 (estimated)
Updated on ClinicalTrials.gov	2026-05-12