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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Smoking Cessation; Nurse's Role; Smoking Behaviors
• Intervention / Treatment: Behavioral: behavioural and cessation aids

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Viken
    • Drammen, Viken, Norway, 3004
      • Drammen Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Intervention group	Behavioral: behavioural and cessation aids; information, motivational interview, refferal to healty life-centers, free cessation aids

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Vestre Viken Hospital Trust
• Collaborators: University of Oslo; Norwegian Institute of Public Health; Oslo University Hospital; Norwegian Directorate of Health
• Investigators: Principal Investigator: John munkhaugen, MD, PhD, Vestre Viken Trust, Drammen hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2021
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: January 7, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (Actual): February 26, 2021

Study Record Updates

• Last Update Posted (Actual): October 18, 2022
• Last Update Submitted That Met QC Criteria: October 17, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: REK 202686

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No