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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05049174
• Other study ID #: 270267
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: April 30, 2024

Study information

• Verified date: March 2024
• Source: Vestre Viken Hospital Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 221
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

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

Locations

Country	Name	City	State
Norway	Drammen Hospital	Drammen	Viken
Norway	Ringerike Hospital	Hønefoss	Viken
Norway	Kongsberg Hospital	Kongsberg	Viken

Sponsors (5)

Lead Sponsor	Collaborator
Vestre Viken Hospital Trust	Norwegian Directorate of Health, Norwegian Institute of Public Health, Oslo University Hospital, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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 2 years follow-up
Secondary	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 5 years follow-up