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Completed

NCT Number: NCT04772144

Nurse-led Smoking Cessation With Further Follow-up in Lifestyle Centres - a 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.

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Key information

Conditions

Smoking Cessation Behavior Cardiovascular Diseases Health Behavior Nurse's Role Smoking Smoking Behaviors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Drammen Hospital

Drammen, Akershus, 3004, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

behavioural and cessation aids

Behavioral

information, motivational interview, refferal to healty life-centers, free cessation aids

Primary outcomes

  1. 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

    Time frame: 8-12 weeks after randomization

    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

  2. Differences in use of smoking cessation aids between the intervention group and the control group

    Time frame: 8-12 weeks after randomization

    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

Secondary outcomes

  1. Difference in point prevalence of smoke-free (no cigarettes last 7 days) after 6 months

    Time frame: 12 weeks after randomization

    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

  2. Difference between the groups in proportion who quit smoking between the groups

    Time frame: 12 weeks after randomization

    Difference between the groups in proportion who quit smoking between the groups measured by the level of carbon monoxide in the exhaled air

Sponsors and collaborators

Lead sponsor

Vestre Viken Hospital Trust

Other

Collaborators

  • Norwegian Directorate of Health
  • Norwegian Institute of Public Health
  • Oslo University Hospital
  • University of Oslo

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 26, 2021
Registry last updated
Oct 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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