F17
Conditions
Interventions
Group 1: Intervention group: Receives a time-defined, multi-stage smoking cessation counseling according to the S3 guideline "Smoking and tobacco dependence: screening, diagnostics, and treatment". Le
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Sponsors
Uniklinik RWTH Aachen
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Participants will only be included if patient documentation at one of the recruitment hospitals proves that the following criteria are met at the time of enrollment: 1. Patient is between = 18 and = 80 years old. 2. Patient is mentally and physically capable of understanding the study's meaning and scope and can follow the investigators' instructions. 3. The patient's written informed consent was obtained before study participation. 4. The patient underwent an invasive revascularization therapy due to peripheral arterial occlusive disease (pAVK) at Fontaine stage II or higher within the last 14 days, or more than 14 days ago, either on an inpatient or outpatient basis. Alternatively, the patient is currently receiving inpatient or outpatient treatment for pAVK at Fontaine stage II or higher without a history of invasive revascularization therapy 5. Active smoker.
Exclusion criteria
Exclusion criteria: Participants will only be included if documentation proves that the following criteria are not met at the time of enrollment: 1. Patient is not independently able to give consent. 2. Patient is pregnant or breastfeeding. 3. Patient suffers from a chronic dermatologic or respiratory disease. 4. Patient can't provide an appropriate compatible device to participate in the psychological-telemedical withdrawal consultation. 5. Judged by the investigator, the patient's participation may bear an unreasonable risk due to the patient's general condition. 6. Patient has a life expectancy of fewer than six months. 7. Preexisting present and past medical conditions or treatments could influence the study and the study evaluation. 8. The patient has used another smoking cessation medication within a clinical trial within the past 30 days or is enrolled in another clinical interventional study in the course of this trial. 9. The patient is expected to show missing compliance. 10. The patient is placed in an institution due to official or legal orders. 11. The patient is in a dependent relationship or employment with the sponsor, investigator, or representative.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the abstinence rate at post-intervention (T4 = 8 months after the start of the intervention). Abstinence rate = Percentage of patients in the intervention- and the control group that quit smoking at T4. At T4, we aim to achieve the following: a) an elevated abstinence rate within patients receiving the multi-stage psychological-telemedical withdrawal consultation vs. the patients in the control-group receiving usual consultation (superiority proof), b) a relevant group difference (significance level 5 %) of at least 10% in the abstinence rates between intervention- and control group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of the abstinence rate at post-intervention (T5 = 14 months after the start of the intervention). This will follow the same methodology used for the primary outcome measure. Abstinence rate = Percentage of patients in the intervention- and the control group that quit smoking at T5. At T5, we aim to achieve the following: a) an elevated abstinence rate within patients receiving the multi-stage psychological-telemedical withdrawal consultation vs. the patients in the control-group receiving usual consultation (superiority proof), b) a relevant group difference (significance level 5 %) of at least 10% in the abstinence rates between intervention- and control group. | — |
Countries
Germany
Contacts
Public ContactSebastian Scheliga
Uniklinik RWTH Aachen, Klinik für Psychiatrie, Psychotherapie und Psychosomatik
Outcome results
None listed