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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04772144
Recruitment Status : Active, not recruiting
First Posted : February 26, 2021
Last Update Posted : November 2, 2021
Sponsor:
Collaborators:
University of Oslo
Norwegian Directorate of Health
Oslo University Hospital
Norwegian Institute of Public Health
Information provided by (Responsible Party):
Vestre Viken Hospital Trust

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Smoking Behaviors Nurse's Role Cardiovascular Diseases Behavioral: behavioural and cessation aids Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: patients were randomized to an in-hospital nurse-led smoking cessation intervention with prescription of free cessation aids and systematic referrral to healthy life-centeres or usual care
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
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
Actual Study Start Date : February 25, 2021
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention group Behavioral: behavioural and cessation aids
information, motivational interview, refferal to healty life-centers, free cessation aids
No Intervention: Control group


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04772144


Locations
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Norway
Drammen Hospital
Drammen, Viken, Norway, 3004
Sponsors and Collaborators
Vestre Viken Hospital Trust
University of Oslo
Norwegian Directorate of Health
Oslo University Hospital
Norwegian Institute of Public Health
Investigators
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Principal Investigator: John munkhaugen, MD, PhD Vestre Viken Trust, Drammen hospital
More Information
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Responsible Party: Vestre Viken Hospital Trust
ClinicalTrials.gov Identifier: NCT04772144    
Other Study ID Numbers: REK 202686
First Posted: February 26, 2021    Key Record Dates
Last Update Posted: November 2, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases