Nurse-led Smoking Cessation Program With Follow-up in Healthy Life Centres: a Randomized Clinical… (NCT05049174) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Nurse-led Smoking Cessation Program With Follow-up in Healthy Life Centres: a Randomized Clinical Trial
Norway221 participantsStarted 2021-11-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is run through Healthy Life Centres with nurses leading the program — is there a Healthy Life Centre near me that's involved, and would that kind of setup actually fit into my daily routine?
2The trial is no longer recruiting new participants, so could you help me find a similar nurse-led smoking cessation program that's currently open, or is there an equivalent service available to me right now?
3The main thing this study is measuring is whether people have stopped smoking at six months — how does that compare to the quit rates I might expect from the smoking cessation support you'd normally recommend for me?
4Since this trial is looking at cardiovascular disease as one of its areas of concern, does my own heart health make it especially urgent for me to quit, and should that change which cessation approach we consider first?
5This is listed as a Phase NA trial, meaning it's testing a care delivery approach rather than a new drug — does that affect the safety profile compared to what I'd get through standard NHS or GP-referred cessation support?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference between the groups in point prevalence of self-report smoking abstinence at six months follow-up