Smoking Cessation Clinical Trial
— So-Lo-MoOfficial title:
A Randomized Open-label Parallel-group Trial is to Analyze the Efficacy and the Efficiency of the Social-Local-Mobile (So-Lo-Mo) Intervention Applied to the Smoking Cessation Process.
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.
Status | Completed |
Enrollment | 240 |
Est. completion date | October 24, 2018 |
Est. primary completion date | October 24, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Smoking population attending to the Smoking Cessation Unit of "Virgen del RocĂo" 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. Exclusion Criteria: - Subjects had some previous adverse effects related to the pharmacological treatment included in the study |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla | Andaluz Health Service, European Commission |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy: Smoking abstinence rate | 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. | 1 year | |
Primary | Efficiency: Incremental Cost-Effectiveness Ratio | 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. | 1 year | |
Secondary | Incidence of Treatment-Related Adverse Events [Safety] | 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. |
1 year | |
Secondary | International Physical Activity Questionnaire (IPAQ27) score [Physical activity] | 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 |
From baseline (first evaluation in the study) to 1 year after | |
Secondary | Body Mass Index (BMI) in kg/m^2 [Healthy lifestyle] | 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). | From baseline (first evaluation in the study) to 1 year after |
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