Smoking cessation Mental and Behavioural Disorders Mental and behavioural disorders due to use of tobacco
Conditions
Interventions
The EUROACTION programme is a comprehensive, nurse co-ordinated lifestyle programme addressing smoking cessation (with the option of using varenicline), healthy eating and increased physical activity
Sponsors
Imperial College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Vascular patients and partners: 1. Patients with a medical diagnosis of coronary or other atherosclerotic disease: 1.1. Acute myocardial infarction (ST segment elevation myocardial infarction [STEMI] or non-ST segment elevation myocardial infarction [NSTEMI]) 1.2. Unstable angina 1.3. Stable angina pectoris 1.4. Elective revascularisation: coronary artery bypass graft (CABG), percutaneous transluminal angioplasty (PTCA) 1.5. Stroke 1.6. Transient ischaemic attack (TIA) 1.7. Peripheral vascular disease (PVD) 2. Have been smoking 5 or more cigarettes per day within the last month 3. Willing to make a quit attempt 4. Aged 18 years of age or older, but less than 80 years, either sex The partners of all recruited coronary patients will also be identified and invited to participate in the preventive cardiology programme. Those who are smoking will also be offered the same smoking cessation service including varenicline. High-risk people and partners: 1. Have been smoking 5 or more cigarettes per day within the last month 2. Willing to make a quit attempt 3. Men and women, 50 years of age or older, but less than 80 years, either sex 4. Either: 4.1. Newly identified high multifactorial risk individuals: CVD risk equal or greater than 5% over 10 years (now or projected to age 60 years), according to the HeartScore risk estimation system; or 4.2. Have been treated with antihypertensive and/or lipid-lowering therapies; or 4.3. Have diabetes mellitus The partners of all recruited high risk patients will also be identified and invited to participate in the preventive cardiology programme. Those who are smoking will also be offered the same smoking cessation service including varenicline.
Exclusion criteria
Exclusion criteria: Vascular patients: 1. Severe heart failure 2. Severe physical disability 3. Impaired cognitive function 4. Patients with acute coronary syndromes, with or without revasularisation, will not be included in the study until 2 weeks has elapsed following their coronary event 5. Hypersensitivity to varenicline (active substance or to any of the inactive ingredients) 6. History of suicidal attempt 7. History of psychosis 8. Bipolar disorders 9. Panic disorders 10. Epilepsy 11. History of alcohol dependence High-risk people: 1. History of coronary or other atherosclerotic disease 2. Severe heart failure 3. Severe physical disability 4. Impaired cognitive function 5. Hypersensitivity to varenicline (active substance or to any of the inactive ingredients) 6. History of suicidal attempt within the last 10 years 7. History of psychosis 8. Bipolar disorders 9. Panic disorders 10. Epilepsy 11. History of alcohol dependence
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seven-day point (period) prevalence of non-smoking at 16 weeks. The smoking cessation will be validated by breath carbon monoxide (CO) less than 10 ppm. Patients will be classified as non-smokers if they are not smoking in the week prior to their 16 week assessment even if they have relapsed several times in the intervening period. If they are smoking in that same week, and/or breath CO is raised, they will be classified as smokers. The primary outcome is the prevalence of non-smokers in intervention compared to usual care. The proportions of vascular patients and high risk individuals who achieve the primary outcome at 16 weeks will be analysed separately for each of these two diagnostic groups. Partners will be analysed separately but this is not a pre-specified end point and there are no power calculations. However, in a family based intervention it's important to offer the partners the same package, including the smoking cessation intervention. We estimate the number of smoking partners to be about 60% from EUROACTION. This high figure is expected given the concordance for smoking within families. We assume that at least one quarter of all partners who smoke will want to try to quit smoking. | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at 16 week follow-up: 1. Number of smoking relapses in intervention. Smoking relapse is defined as "the time to last cigarette from the start of varenicline" 2. Adverse effects 3. Proportions of patients achieving European and national lifestyle, risk factors and therapeutic targets for cardiovascular disease prevention: 3.1. Smoking (self reported, breath CO) 3.2. Diet/nutrition (self reported, food habit questionnaire) 3.3. Physical activity (self reported, step counter, Chester step test, Duke Activity Status Index [DASI] physical activity questionnaire) 3.4. Overweight/obesity (body mass index (BMI), waist circumference) 3.5. Diabetes (known/new, fasting and random plasma glucose, glycated haemoglobin [Hb A1c] in patients with diabetes) 3.6. Blood pressure 3.7. Total cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides, calculated low-density lipoprotein (LDL) cholesterol 3.8. Smoking cessation drug therapies: 3.8.1. Varenicline 3.8.2. Nicotine replacement therapy 3.8.3. Bupropion hydrochloride 3.9. Cardioprotective drug therapies 4. Patient reported outcomes: Hospital Anxiety and Depression Scale (HADS), Quality of Life (EQ-5D) | — |
Countries
Denmark, Italy, Netherlands, Spain, United Kingdom
Outcome results
None listed