心室辅助装置支持下患者的课程自我管理可减轻抑郁：一项多中心随机对照试验。
Curricular Self-management for patients on ventricular assist device support decreases depression: A multicenter randomized controlled trial.
作者信息
Kugler Christiane, Spielmann Hannah, Richter Fabian, Lauenroth Volker, Semmig-Könze Sandra, Spitz-Köberich Christine, Bertsche Tim, Staus Paulina, Weber Susanne, Albert Wolfgang, Tigges-Limmer Katharina
机构信息
Faculty of Medicine, Institute of Nursing Science, University of Freiburg, Freiburg, Germany.
Department of Cardiothoracic and Vascular Surgery, German Heart Center Charité, Berlin, Germany.
出版信息
Artif Organs. 2025 Mar;49(3):373-389. doi: 10.1111/aor.14918. Epub 2024 Dec 3.
BACKGROUND
Utilization of ventricular assist device (VAD) support in patients with end-stage heart failure is well advanced. Recent studies emphasize the need to develop and evaluate evidence-based psychosocial support interventions for patients following VAD implantation.
METHODS
A national, multi-center study in four established German heart centers was initiated. An evidence-based VAD curriculum was developed; a randomized controlled trial evaluated the impact of the interprofessional intervention over time. Primary combined endpoint was the occurrence of adverse events (thromboembolic events, driveline infections, bleeding, rehospitalization, and death); secondary endpoints were psychosocial outcomes (anxiety, depression [HADS], quality of life [QoLVAD], social support [FSoZu], and self-management [SELMA]). A total of 140 patients were randomized block-wise to intervention (IG n = 70) or control (CG n = 70). Center-effects were considered. Instruments were completed at four time points (T0-T3).
RESULTS
At baseline, intervention group (IG) patients were 19% female (control group [CG] 19%; p = 0.982); 58 ± 11 years. (CG 58 ± 11 years.; p = 0.966); 80% were implanted electively (CG 79%; p = 0.968). No significant difference in primary endpoint was found between IG versus CG (p > 0.05). For secondary endpoints, mixed linear regression revealed a significant reduction in depression scores in IG compared to CG (est. 1.18; 95% CI -2.17 to -0.18; p = 0.021). Clinically significant reductions in anxiety were greater in IG patients between T0 and T3 (IG 51.9%; CG 40.7%); increased anxiety was reported in 3.7% IG (11.1% CG). Mixed linear regression analyses favored IG (all >0.05) for QoL, social support, and self-management.
CONCLUSION
A comprehensive curricular VAD intervention has potential to decrease depression levels and improve psychosocial outcomes of patients on VAD support.
背景
终末期心力衰竭患者使用心室辅助装置（VAD）进行支持治疗已相当成熟。最近的研究强调，需要为接受VAD植入的患者制定和评估基于证据的心理社会支持干预措施。
方法
在德国四个成熟的心脏中心开展了一项全国性、多中心研究。制定了基于证据的VAD课程；一项随机对照试验评估了跨专业干预随时间的影响。主要联合终点是不良事件（血栓栓塞事件、驱动线感染、出血、再次住院和死亡）的发生；次要终点是心理社会结局（焦虑、抑郁[医院焦虑抑郁量表]、生活质量[VAD生活质量量表]、社会支持[社会支持问卷]和自我管理[自我管理量表]）。总共140例患者按随机区组法随机分为干预组（IG，n = 70）或对照组（CG，n = 70）。考虑了中心效应。在四个时间点（T0 - T3）完成各项评估工具。
结果
基线时，干预组（IG）患者中女性占19%（对照组[CG]为19%；p = 0.982）；年龄为58 ± 11岁（CG为58 ± 11岁；p = 0.966）；80%为择期植入（CG为79%；p = 0.968）。IG组与CG组在主要终点方面未发现显著差异（p > 0.05）。对于次要终点，混合线性回归显示，与CG组相比，IG组的抑郁评分显著降低（估计值1.18；95%置信区间为 -2.17至 -0.18；p = 0.021）。IG组患者在T0至T3期间焦虑的临床显著降低幅度更大（IG组为51.9%；CG组为40.7%）；IG组报告焦虑增加的比例为3.7%（CG组为11.1%）。混合线性回归分析在生活质量、社会支持和自我管理方面更倾向于IG组（均>0.05）。
结论
全面的课程式VAD干预有可能降低接受VAD支持患者的抑郁水平并改善其心理社会结局。
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