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

Vestre Viken Hospital Trust

Status: Active, not recruiting

Conditions: Cardiovascular Diseases; Smoking Behaviors; Nurse's Role; Smoking Cessation

Treatments: Behavioral: Nuse-led interview and referral to municipal healthy life-centres

Study type: Interventional

Funder types: Other

Identifiers

NCT05049174

270267

Details and patient eligibility

About

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.

Enrollment: 221 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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221 participants in 2 patient groups

Intensive intervention

Experimental group

Treatment:

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

Low-threshold intervention

Active Comparator group

Treatment:

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