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

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ClinicalTrials.gov Identifier: NCT05049174
Recruitment Status : Recruiting
First Posted : September 20, 2021
Last Update Posted : October 19, 2022
Sponsor:
Collaborators:
University of Oslo
Oslo University Hospital
Norwegian Directorate of Health
Norwegian Institute of Public Health
Information provided by (Responsible Party):
Vestre Viken Hospital Trust

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Smoking Behaviors Nurse's Role Cardiovascular Diseases Behavioral: Nuse-led interview and referral to municipal healthy life-centres Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants were randomized 1:1 to an in-hospital nurse-led smoking cessation intervention with systematic referrral to the municipal healthy life-centres or to written information about smoking cessation and the municipal health service program.
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
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
Actual Study Start Date : November 1, 2021
Estimated Primary Completion Date : February 15, 2024
Estimated Study Completion Date : February 15, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intensive 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
Active Comparator: Low-threshold 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


Outcome Measures
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Primary Outcome Measures :
  1. Difference between the groups in point prevalence of self-report smoking abstinence at six months follow-up [ Time Frame: Six months after randomization ]
    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


Secondary Outcome Measures :
  1. Difference between the groups in proportion who quit smoking determined with objectively [ Time Frame: Six months after randomization ]
    Difference between the groups in proportion of participants who quit smoking measured by the level of carbon monoxide in the exhaled air

  2. Difference between the groups in point prevalence of self-report smoking abstinence three months after randomization [ Time Frame: 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

  3. Difference between the groups in point prevalence of self-report smoking abstinence 12 months after randomization [ Time Frame: Twelve 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

  4. Differences in participation rate at healthy life-centres between the groups [ Time Frame: 8 to 12 weeks after randomization ]
    Differences in participation rate at healthy life-centres between the groups measured by telephone interview with personnell at the healthy life-centres

  5. Differences in use of smoking cessation aids between the groups [ Time Frame: 8 to 12 weeks after randomization ]
    Differences in the proportion of patients who use of smoking cessation aids (nicotine replacement therapy) between the groups measured by patient self-report

  6. 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 [ Time Frame: From baseline until 12 months follow-up ]
    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

  7. 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 [ Time Frame: From baseline until 2 years follow-up ]
    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

  8. 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 [ Time Frame: From baseline until 5 years follow-up ]
    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


Other Outcome Measures:
  1. Differences in changes in clinical and psychological factors between the study groups [ Time Frame: From baseline until 6 months follow-up ]
    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


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:

  • 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)
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): NCT05049174


Contacts
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Contact: John Munkhaugen, MD, PhD +47 97524194 johmun@vestreviken.no
Contact: Elise Sverre, MD, PhD +47 99020329 elisbj@vestreviken.no

Locations
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Norway
Drammen Hospital Recruiting
Drammen, Viken, Norway, 3004
Contact: John Munkhaugen, MD, PhD    +4797524194    johmun@vestreviken.no   
Contact: Elise Sverre, MD, PhD    +4799020329    elisbj@vestreviken.no   
Ringerike Hospital Recruiting
Hønefoss, Viken, Norway, 3511
Contact: Marie Stugaard, MD, PhD         
Kongsberg Hospital Recruiting
Kongsberg, Viken, Norway, 3612
Contact: Mohpal Kahlon, MD         
Sponsors and Collaborators
Vestre Viken Hospital Trust
University of Oslo
Oslo University Hospital
Norwegian Directorate of Health
Norwegian Institute of Public Health
More Information
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Responsible Party: Vestre Viken Hospital Trust
ClinicalTrials.gov Identifier: NCT05049174    
Other Study ID Numbers: 270267
First Posted: September 20, 2021    Key Record Dates
Last Update Posted: October 19, 2022
Last Verified: October 2022

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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