Scientific evaluation of a telemedical psychological intervention to promote smoking cessation in patients with peripheral arterial occlusive disease

niklinik RWTH Aachen0 个研究点目标入组 826 人开始时间: 2023年3月6日最近更新: 2024年8月19日

适应症

试验速览

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•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.

•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.

发起方

niklinik RWTH Aachen