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

Not Applicable

Active, not recruiting

• Conditions: Smoking Cessation; Nurse's Role; Cardiovascular Diseases; Smoking Behaviors
• Interventions: Behavioral: Nuse-led interview and referral to municipal healthy life-centres

• Registration Number: NCT05049174
• Lead Sponsor: Vestre Viken Hospital Trust

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-10
• Study First Submitted QC: 2021-09-10
• Study First Posted: 2021-09-20
• Study Start: 2021-11-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-13
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 221

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive intervention	Nuse-led interview and referral to municipal healthy life-centres	-
Low-threshold intervention	Nuse-led interview and referral to municipal healthy life-centres	-

Primary Outcome Measures

Name	Time	Method
Difference between the groups in point prevalence of self-report smoking abstinence at six months follow-up	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 Outcome Measures

Name	Time	Method
Differences in use of smoking cessation aids between the groups	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
Difference between the groups in proportion who quit smoking determined with objectively	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
Difference between the groups in point prevalence of self-report smoking abstinence three months after randomization	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
Difference between the groups in point prevalence of self-report smoking abstinence 12 months after randomization	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
Differences in participation rate at healthy life-centres between the groups	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
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	From baseline until 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

Trial Locations

Locations (3)

Kongsberg Hospital; 🇳🇴 Kongsberg, Viken, Norway

Drammen Hospital; 🇳🇴 Drammen, Viken, Norway

Ringerike Hospital; 🇳🇴 Hønefoss, Viken, Norway