Department of Psychiatry, Psychotherapy and Psychosomatics, Faculty of Medicine, RWTH Aachen University, Aachen, Germany.
Clinic for Vascular Medicine, Klinik Für Angiologie, HELIOS Klinik Krefeld, Lutherplatz 40, Krefeld, 47805, Germany.
BMC Public Health. 2024 Oct 2;24(1):2695. doi: 10.1186/s12889-024-20192-7.
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.
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.
吸烟是心血管疾病的主要危险因素，尤其是外周动脉疾病（PAD）。尽管存在这种联系，但关于 PAD 患者戒烟干预的研究仍然很少，并且关于这些干预措施的效果也没有定论。因此，阐明这一点至关重要，应该既针对有戒烟意愿的吸烟者，也针对那些没有戒烟意愿但吸烟量大的吸烟者。
方法/设计：Aachen Smoking Cessation and Harm Reduction（ASCHR）试验是一项关于远程医疗-心理支持对 PAD 患者戒烟益处的前瞻性随机对照研究（RCT），由德国联邦联合委员会的“创新基金”资助。该试验旨在科学评估基于德国戒烟指南建议的多阶段戒烟计划的疗效、可行性、接受度和效率，该计划针对 PAD 患者量身定制，与不接受干预的对照组进行比较。该计划的核心是利用动机访谈技术进行的心理辅导，通过视频咨询通过远程医疗提供。ASCHR 试验的主要终点是干预 8 个月后的戒烟率，次要终点是进一步 6 个月随访时的持续戒烟率。戒烟定义为呼气中一氧化碳水平低于 6ppm。我们假设接受多阶段戒烟计划的组的戒烟率将比常规护理至少高 10 个百分点。预计脱落率约为 35%，计划的样本量至少为 N = 1032 名研究参与者。
如果试验显示出显著的积极结果，应努力将该计划纳入德国的常规护理中，这可能为未来 PAD 患者的戒烟支持提供一个有前途的基础。
