Nurse-led Smoking Cessation With Further Follow-up in Lifestyle Centres - a Randomized Pilot Study

Cardiovascular Diseases Clinical Trial

Official title:

Smoking Cessation After a Cardiovascular Disease Event With Hospital-based Nurse-coordination and Further Follow-up Care in Lifestyle Centres With Free Cessation Aids - an Interdisciplinary Randomized Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04772144
• Other study ID #: REK 202686
• Status: Completed
• Phase: N/A
• Start date: February 25, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: October 2022
• Source: Vestre Viken Hospital Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this randomized controlled pilot study is to test whether an in-hospital nurse-led smoking cessation intervention increases the refferal rate to healty life-centers in the municipalities. We will also describe the proportion who succeed in quitting smoking between the intervention group and the control group and obtain new knowledge about the patient and system factors of importance for participation to healty life-centers and for successful and unsuccessful smoking cessation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria (all):

• Age> 18 years and smokes at least 1 cigarette daily
• Hospitalized with a cardiovascular event (i.e. myocardial infarction, heart failure, unstable or stable angina, achyarrhythmias, bradyarrhythmias, carotid stenosis or claudication with need for peripheral revascularization)
• Sign informed consent and is expected to participate according to ICH / GCP

Exclusion Criteria (none of these):

• Does not meet the criteria to participate in the pilot project, i.e. patients who do not usually live or work in the Vestre Viken catchment area
• Chronic renal failure stage 4 or known allergic reaction to varenicline . 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:
• behavioural and cessation aids
information, motivational interview, refferal to healty life-centers, free cessation aids

Locations

Country	Name	City	State
Norway	Drammen Hospital	Drammen	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
Primary	Differences in participation rate at healthy life-centers between the intervention group and the control group measured by telephone interview with personnell at the healthy life-centers	Differences in participation rate at healthy life-centers between the intervention group and the control group measured by telephone interview with personnell at the healthy life-centers	8-12 weeks after randomization
Primary	Differences in use of smoking cessation aids between the intervention group and the control group	Differences in use of smoking cessation aids between the intervention group and the control group measued by patient self-report and collected from the prescription mediator in the hospital record	8-12 weeks after randomization
Secondary	Difference in point prevalence of smoke-free (no cigarettes last 7 days) after 6 months	Difference in point prevalence of smoke-free (no cigarettes last 7 days) after 6 months measured with self-reported questionnaires according to the Russell Standard	12 weeks after randomization
Secondary	Difference between the groups in proportion who quit smoking between the groups	Difference between the groups in proportion who quit smoking between the groups measured by the level of carbon monoxide in the exhaled air	12 weeks after randomization