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

NCT05049174 | Active Not Recruiting

• 1 other identifier: 270267
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

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

  Six months after randomization

• 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 point prevalence of self-report smoking abstinence 12 months after randomization

  Twelve months after randomization

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

  8 to 12 weeks after randomization

• Differences in use of smoking cessation aids between the groups

  8 to 12 weeks after randomization

Other Outcomes (1)

• Differences in changes in clinical and psychological factors between the study groups

  From baseline until 6 months follow-up

Study Arms (2)

Intensive intervention

EXPERIMENTAL

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

Low-threshold intervention

ACTIVE COMPARATOR

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

Interventions

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

Intensive intervention; Low-threshold intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Vestre Viken Hospital Trust: lead
• University of Oslo: collaborator
• Oslo University Hospital: collaborator
• Norwegian Directorate of Health: collaborator
• Norwegian Institute of Public Health: collaborator

Study Sites (3)

Drammen Hospital

Drammen, Akershus, 3004, Norway

Location

Ringerike Hospital

Hønefoss, Akershus, 3511, Norway

Location

Kongsberg Hospital

Kongsberg, Akershus, 3612, Norway

Location

MeSH Terms

Conditions

Smoking Cessation; Smoking; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were randomized 1:1 to an in-hospital nurse-led smoking cessation intervention with systematic referrral to the municipal healthy life-centres or to written information about smoking cessation and the municipal health service program.

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: September 20, 2021
• Study Start: November 1, 2021
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

NO (3)