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

• ClinicalTrials.gov Identifier: NCT05049174
• Recruitment Status: Recruiting
• First Posted: September 20, 2021
• Last Update Posted: November 9, 2021
• Sponsor: Vestre Viken Hospital Trust
• 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

Brief Summary:

A better understanding of how to incorporate effective smoking cessation into clinical practice is requested. In this is prospective, multi-center, randomized, open, blinded end-point 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 varenicline or nicotine replacement therapy and the proportion who attended the healthy-life center program between the two groups. 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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 350 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: December 15, 2023
• Estimated Study Completion Date: December 15, 2025

Arms and Interventions

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

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 (varenicline or nicotine replacement therapy) between the groups measured by patient self-report

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

• 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, carotid stenosis or claudication with need for revascularization)
• 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
• 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

Contacts

Contact: John Munkhaugen, MD, PhD; +47 97524194; johmun@vestreviken.no

Contact: Elise Sverre, MD, PhD; +47 99020329; elisbj@vestreviken.no

Locations

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; Not yet recruiting

Hønefoss, Viken, Norway, 3511

Contact: Marie Stugaard, MD, PhD

Kongsberg Hospital; Not yet 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

• Responsible Party: Vestre Viken Hospital Trust
• ClinicalTrials.gov Identifier: NCT05049174
• Other Study ID Numbers: 270267
• First Posted: September 20, 2021
• Last Update Posted: November 9, 2021
• Last Verified: November 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Cardiovascular Diseases