So-Lo-Mo Intervention Applied to the Smoking Cessation Process
- Conditions
- Lifestyle-related ConditionSmoking CessationHealth Behavior
- Interventions
- Registration Number
- NCT03553173
- Brief Summary
This is a randomized open-label parallel-group trial. 240 subjects will be recruited during 8 months and a 12 months follow-up will be carried out for each one of them. The sample will split in two groups: control group (n=120) who will receive usual psycho-pharmacological therapy and the intervention group (n=120) who will receive usual therapy plus So-Lo-Mo app.
- Detailed Description
The main objective of this study is to analyze the efficacy and efficiency of the So-Lo-Mo intervention applied to the smoking cessation process compared to usual care.
Secondary objectives are:
1. To monitor usual psycho-pharmacological therapies (bupropion, varenicline and behavioural therapy).
2. To monitor healthy lifestyle and physical exercise habits.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
- Smoking population attending to the Smoking Cessation Unit of "Virgen del Rocío" University Hospital.
- Subjects >18 years old who want to give up smoking.
- Android-based smart phone availability.
- Ability to interact with the smart phone.
- To sign an Informed Consent Form.
- Subjects had some previous adverse effects related to the pharmacological treatment included in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Varenicline Pill Subjects undergoing usual psycho-pharmacological treatment for smoking cessation. Prescribed treatments: * Bupropion pills + Psychological advice * Varenicline pills + Psychological advice Intervention Varenicline Pill Subjects undergoing usual psycho-pharmacological treatment for smoking cessation plus a smart phone App. Prescribed treatments: * Bupropion pills + Psychological advice + So-Lo-Mo * Varenicline pills + Psychological advice + So-Lo-Mo Control Psychological advice Subjects undergoing usual psycho-pharmacological treatment for smoking cessation. Prescribed treatments: * Bupropion pills + Psychological advice * Varenicline pills + Psychological advice Control Bupropion Pill Subjects undergoing usual psycho-pharmacological treatment for smoking cessation. Prescribed treatments: * Bupropion pills + Psychological advice * Varenicline pills + Psychological advice Intervention Psychological advice Subjects undergoing usual psycho-pharmacological treatment for smoking cessation plus a smart phone App. Prescribed treatments: * Bupropion pills + Psychological advice + So-Lo-Mo * Varenicline pills + Psychological advice + So-Lo-Mo Intervention Bupropion Pill Subjects undergoing usual psycho-pharmacological treatment for smoking cessation plus a smart phone App. Prescribed treatments: * Bupropion pills + Psychological advice + So-Lo-Mo * Varenicline pills + Psychological advice + So-Lo-Mo Intervention So-Lo-Mo Subjects undergoing usual psycho-pharmacological treatment for smoking cessation plus a smart phone App. Prescribed treatments: * Bupropion pills + Psychological advice + So-Lo-Mo * Varenicline pills + Psychological advice + So-Lo-Mo
- Primary Outcome Measures
Name Time Method Efficacy: Smoking abstinence rate 1 year Smoking abstinence rate at 1 year measured by means of exhaled Carbon Monoxide (CO) and urinary cotinine tests. Subjects with cotinine concentrations \>200 ng/ml or CO \>6 ppm will be considered as smokers.
Efficiency: Incremental Cost-Effectiveness Ratio 1 year Expressed in terms of Incremental Cost-Effectiveness Ratio (ICER), calculated by dividing the difference in total costs between the intervention group and the control group by the difference in Quality-Adjusted Life Year (QALY) between both groups. Costs associated to control and intervention groups will include healthcare resources utilization measured in terms of specialist consultations related to the smoking cessation process. Costs of pharmacological treatment and time employed by healthcare professionals during the design phase will also be taken into account. Benefit for patients will be expressed in terms of QALY. EuroQol-5D-5L questionnaire will be used to estimate QALY.
- Secondary Outcome Measures
Name Time Method Incidence of Treatment-Related Adverse Events [Safety] 1 year To monitor usual pharmacological therapies (bupropion and varenicline) in order to gather the incidence of related adverse events reported. Safety will be measured as the number of adverse events related to pharmacological therapies. The following adverse events have been identified related to each pharmacological therapy:
Varenicline: Nausea, vomit, headache, insomnia, abnormal dreams, constipation and flatulence.
Bupropion: insomnia, headache, dryness in the mouth, alteration of taste, skin reactions, convulsions, cardiovascular side effects and severe skin reactions.Body Mass Index (BMI) in kg/m^2 [Healthy lifestyle] From baseline (first evaluation in the study) to 1 year after Healthy lifestyle will be measured in terms of the subject's BMI (weight in kg / height in m\^2) at baseline (first evaluation in the study) and at the end of the intervention (after 1 year of follow-up).
International Physical Activity Questionnaire (IPAQ27) score [Physical activity] From baseline (first evaluation in the study) to 1 year after Physical activity will be measured in terms of the International Physical Activity Questionnaire (IPAQ27) score calculation at baseline (first evaluation in the study) and at the end of the intervention (after 1 year of follow-up). The result is expressed as metabolic equivalent (MET)-minutes per week. Interpretation:
* Low: Individuals who not meet criteria for categories 2 or 3 are considered 'low'
* Moderate: 3 or more days of vigorous-intensity activity of at least 20 minutes per day OR 5 or more days of moderate-intensity activity and/or walking of at least 30 minutes per day OR 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum Total physical activity of at least 600 MET-minutes/week
* High: vigorous-intensity activity on at least 3 days achieving a minimum Total physical activity of at least 1500 MET-minutes/week