Aachen smoking cessation and harm reduction (ASCHR) trial study protocol – scientific evaluation of a psychological-telemedical counseling concept for smoking cessation in patients with vascular diseases

Abstract Background Smoking is a major risk factor of cardiovascular diseases, notably peripheral arterial disease (PAD). Despite this link, research on smoking cessation interventions in PAD patients remains scarce and inconclusive regarding the efficacy of such interventions. Therefore, elucidatin...

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Main Authors: Sebastian Scheliga, Mara Derissen, Knut Kröger, Rainer Röhrig, Lea Schomacher, Hannah Schick, Rainer Beckers, Hinrich Böhner, Ute Habel
Format: Article
Language:English
Published: BMC 2024-10-01
Series:BMC Public Health
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Online Access:https://doi.org/10.1186/s12889-024-20192-7
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author Sebastian Scheliga
Mara Derissen
Knut Kröger
Rainer Röhrig
Lea Schomacher
Hannah Schick
Rainer Beckers
Hinrich Böhner
Ute Habel
author_facet Sebastian Scheliga
Mara Derissen
Knut Kröger
Rainer Röhrig
Lea Schomacher
Hannah Schick
Rainer Beckers
Hinrich Böhner
Ute Habel
author_sort Sebastian Scheliga
collection DOAJ
description Abstract Background Smoking is a major risk factor of cardiovascular diseases, notably peripheral arterial disease (PAD). Despite this link, research on smoking cessation interventions in PAD patients remains scarce and inconclusive regarding the efficacy of such interventions. Therefore, elucidating it is crucial and should address both individuals who smoke that are motivated to quit and individuals who smoke heavily lacking the motivation to quit. Methods/Design The Aachen Smoking Cessation and Harm Reduction (ASCHR) trial is a prospective randomized controlled study (RCT) on the benefits of telemedical-psychological support for smoking cessation in patients with PAD, funded by the “Innovation Fund” of the Joint Federal Committee in Germany. This trial aims to scientifically assess the efficacy, feasibility, acceptance, and efficiency of a multi-stage smoking cessation program based on the recommendations of the German guideline for smoking cessation tailored to patients with PAD, compared to a control group receiving no intervention. Central to the program is psychological counseling utilizing motivational interviewing techniques, delivered through telemedicine via video consultations. The primary endpoint of the ASCHR trial is the smoking cessation rate after 8 months of intervention, with a secondary endpoint evaluating sustained abstinence at a further 6 months follow-up. Smoking cessation is defined as a carbon monoxide level in exhaled air of less than 6 ppm. We hypothesize that the group receiving the multi-stage cessation program will yield a cessation rate at least 10 percentage points higher than that of usual care. Anticipating a dropout rate of around 35%, the planned sample size is at least N = 1032 study participants. Discussion Should the trial demonstrate significant positive outcomes, efforts should be made to integrate the program into routine care in Germany, potentially offering a promising base for future smoking cessation support among PAD patients.
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spelling doaj-art-63b4eeaf8a314b398bbddf59e0ccfb062025-08-20T01:57:13ZengBMCBMC Public Health1471-24582024-10-012411910.1186/s12889-024-20192-7Aachen smoking cessation and harm reduction (ASCHR) trial study protocol – scientific evaluation of a psychological-telemedical counseling concept for smoking cessation in patients with vascular diseasesSebastian Scheliga0Mara Derissen1Knut Kröger2Rainer Röhrig3Lea Schomacher4Hannah Schick5Rainer Beckers6Hinrich Böhner7Ute Habel8Department of Psychiatry, Psychotherapy and Psychosomatics, Faculty of Medicine, RWTH Aachen UniversityDepartment of Psychiatry, Psychotherapy and Psychosomatics, Faculty of Medicine, RWTH Aachen UniversityClinic for Vascular Medicine, Klinik Für Angiologie, HELIOS Klinik KrefeldInstitute for Medical Informatics, RWTH Aachen UniversityZTG Center for Telematics and Telemedicine GmbHZTG Center for Telematics and Telemedicine GmbHZTG Center for Telematics and Telemedicine GmbHDepartment of General and Visceral Surgery, Catholic Hospital Dortmund WestDepartment of Psychiatry, Psychotherapy and Psychosomatics, Faculty of Medicine, RWTH Aachen UniversityAbstract Background Smoking is a major risk factor of cardiovascular diseases, notably peripheral arterial disease (PAD). Despite this link, research on smoking cessation interventions in PAD patients remains scarce and inconclusive regarding the efficacy of such interventions. Therefore, elucidating it is crucial and should address both individuals who smoke that are motivated to quit and individuals who smoke heavily lacking the motivation to quit. Methods/Design The Aachen Smoking Cessation and Harm Reduction (ASCHR) trial is a prospective randomized controlled study (RCT) on the benefits of telemedical-psychological support for smoking cessation in patients with PAD, funded by the “Innovation Fund” of the Joint Federal Committee in Germany. This trial aims to scientifically assess the efficacy, feasibility, acceptance, and efficiency of a multi-stage smoking cessation program based on the recommendations of the German guideline for smoking cessation tailored to patients with PAD, compared to a control group receiving no intervention. Central to the program is psychological counseling utilizing motivational interviewing techniques, delivered through telemedicine via video consultations. The primary endpoint of the ASCHR trial is the smoking cessation rate after 8 months of intervention, with a secondary endpoint evaluating sustained abstinence at a further 6 months follow-up. Smoking cessation is defined as a carbon monoxide level in exhaled air of less than 6 ppm. We hypothesize that the group receiving the multi-stage cessation program will yield a cessation rate at least 10 percentage points higher than that of usual care. Anticipating a dropout rate of around 35%, the planned sample size is at least N = 1032 study participants. Discussion Should the trial demonstrate significant positive outcomes, efforts should be made to integrate the program into routine care in Germany, potentially offering a promising base for future smoking cessation support among PAD patients.https://doi.org/10.1186/s12889-024-20192-7Smoking cessationPeripheral arterial diseaseTelemedicinePsychological support
spellingShingle Sebastian Scheliga
Mara Derissen
Knut Kröger
Rainer Röhrig
Lea Schomacher
Hannah Schick
Rainer Beckers
Hinrich Böhner
Ute Habel
Aachen smoking cessation and harm reduction (ASCHR) trial study protocol – scientific evaluation of a psychological-telemedical counseling concept for smoking cessation in patients with vascular diseases
BMC Public Health
Smoking cessation
Peripheral arterial disease
Telemedicine
Psychological support
title Aachen smoking cessation and harm reduction (ASCHR) trial study protocol – scientific evaluation of a psychological-telemedical counseling concept for smoking cessation in patients with vascular diseases
title_full Aachen smoking cessation and harm reduction (ASCHR) trial study protocol – scientific evaluation of a psychological-telemedical counseling concept for smoking cessation in patients with vascular diseases
title_fullStr Aachen smoking cessation and harm reduction (ASCHR) trial study protocol – scientific evaluation of a psychological-telemedical counseling concept for smoking cessation in patients with vascular diseases
title_full_unstemmed Aachen smoking cessation and harm reduction (ASCHR) trial study protocol – scientific evaluation of a psychological-telemedical counseling concept for smoking cessation in patients with vascular diseases
title_short Aachen smoking cessation and harm reduction (ASCHR) trial study protocol – scientific evaluation of a psychological-telemedical counseling concept for smoking cessation in patients with vascular diseases
title_sort aachen smoking cessation and harm reduction aschr trial study protocol scientific evaluation of a psychological telemedical counseling concept for smoking cessation in patients with vascular diseases
topic Smoking cessation
Peripheral arterial disease
Telemedicine
Psychological support
url https://doi.org/10.1186/s12889-024-20192-7
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