Christiane Kugler, Hannah Spielmann, Fabian Richter, Volker Lauenroth, Sandra Semmig-Könze, Christine Spitz-Köberich, Tim Bertsche, Paulina Staus, Susanne Weber, Wolfgang Albert, Katharina Tigges-Limmer, the Selma Study Group
{"title":"在心室辅助装置支持下患者的自我管理减少抑郁：一项多中心随机对照试验。","authors":"Christiane Kugler, Hannah Spielmann, Fabian Richter, Volker Lauenroth, Sandra Semmig-Könze, Christine Spitz-Köberich, Tim Bertsche, Paulina Staus, Susanne Weber, Wolfgang Albert, Katharina Tigges-Limmer, the Selma Study Group","doi":"10.1111/aor.14918","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Background</h3>\n \n <p>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.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>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 <i>n</i> = 70) or control (CG n = 70). Center-effects were considered. Instruments were completed at four time points (T0-T3).</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>At baseline, intervention group (IG) patients were 19% female (control group [CG] 19%; <i>p</i> = 0.982); 58 ± 11 years. (CG 58 ± 11 years.; <i>p</i> = 0.966); 80% were implanted electively (CG 79%; <i>p</i> = 0.968). No significant difference in primary endpoint was found between IG versus CG (<i>p</i> > 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; <i>p</i> = 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.</p>\n </section>\n \n <section>\n \n <h3> Conclusion</h3>\n \n <p>A comprehensive curricular VAD intervention has potential to decrease depression levels and improve psychosocial outcomes of patients on VAD support.</p>\n </section>\n </div>","PeriodicalId":8450,"journal":{"name":"Artificial organs","volume":"49 3","pages":"373-389"},"PeriodicalIF":2.2000,"publicationDate":"2024-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/aor.14918","citationCount":"0","resultStr":"{\"title\":\"Curricular Self-management for patients on ventricular assist device support decreases depression: A multicenter randomized controlled trial\",\"authors\":\"Christiane Kugler, Hannah Spielmann, Fabian Richter, Volker Lauenroth, Sandra Semmig-Könze, Christine Spitz-Köberich, Tim Bertsche, Paulina Staus, Susanne Weber, Wolfgang Albert, Katharina Tigges-Limmer, the Selma Study Group\",\"doi\":\"10.1111/aor.14918\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Background</h3>\\n \\n <p>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.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods</h3>\\n \\n <p>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 <i>n</i> = 70) or control (CG n = 70). Center-effects were considered. Instruments were completed at four time points (T0-T3).</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>At baseline, intervention group (IG) patients were 19% female (control group [CG] 19%; <i>p</i> = 0.982); 58 ± 11 years. (CG 58 ± 11 years.; <i>p</i> = 0.966); 80% were implanted electively (CG 79%; <i>p</i> = 0.968). No significant difference in primary endpoint was found between IG versus CG (<i>p</i> > 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; <i>p</i> = 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.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusion</h3>\\n \\n <p>A comprehensive curricular VAD intervention has potential to decrease depression levels and improve psychosocial outcomes of patients on VAD support.</p>\\n </section>\\n </div>\",\"PeriodicalId\":8450,\"journal\":{\"name\":\"Artificial organs\",\"volume\":\"49 3\",\"pages\":\"373-389\"},\"PeriodicalIF\":2.2000,\"publicationDate\":\"2024-12-03\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://onlinelibrary.wiley.com/doi/epdf/10.1111/aor.14918\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Artificial organs\",\"FirstCategoryId\":\"5\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1111/aor.14918\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"ENGINEERING, BIOMEDICAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Artificial organs","FirstCategoryId":"5","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1111/aor.14918","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"ENGINEERING, BIOMEDICAL","Score":null,"Total":0}
引用次数: 0
摘要
背景：在终末期心力衰竭患者中使用心室辅助装置（VAD）支持是很先进的。最近的研究强调有必要开发和评估VAD植入后患者的循证心理社会支持干预措施。方法：在德国四个已建立的心脏中心开展了一项全国性的多中心研究。制定了以证据为基础的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的发生（血栓栓塞事件、传动系统感染、出血、再住院和死亡）；次要终点是社会心理结局（焦虑、抑郁[HADS]、生活质量[QoLVAD]、社会支持[FSoZu]和自我管理[SELMA]）。共有140例患者被随机分组分为干预组（IG n = 70）和对照组（CG n = 70）。考虑了中心效应。在4个时间点（T0-T3）完成仪器检查。结果：基线时，干预组（IG）患者中女性占19%(对照组[CG] 19%；p = 0.982)；58±11年。(CG 58±11岁；p = 0.966)；80%选择性植入(CG 79%；p = 0.968)。IG组与CG组的主要终点无显著差异（p < 0.05）。对于次要终点，混合线性回归显示IG组抑郁评分显著低于CG组(test . 1.18；95% CI -2.17 ~ -0.18；p = 0.021)。在T0和T3期间，IG患者焦虑的临床显著降低更大(IG 51.9%；CG 40.7%);3.7% IG组（11.1% CG组）焦虑增加。混合线性回归分析在生活质量、社会支持和自我管理方面支持IG（均为>0.05）。结论：全面的VAD课程干预有可能降低VAD支持患者的抑郁水平并改善心理社会结局。
Curricular Self-management for patients on ventricular assist device support decreases depression: A multicenter randomized controlled trial
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.
期刊介绍：
Artificial Organs is the official peer reviewed journal of The International Federation for Artificial Organs (Members of the Federation are: The American Society for Artificial Internal Organs, The European Society for Artificial Organs, and The Japanese Society for Artificial Organs), The International Faculty for Artificial Organs, the International Society for Rotary Blood Pumps, The International Society for Pediatric Mechanical Cardiopulmonary Support, and the Vienna International Workshop on Functional Electrical Stimulation. Artificial Organs publishes original research articles dealing with developments in artificial organs applications and treatment modalities and their clinical applications worldwide. Membership in the Societies listed above is not a prerequisite for publication. Articles are published without charge to the author except for color figures and excess page charges as noted.
京公网安备 11010802042870号
京ICP备2023020795号-1
分享
求助内容：
应助结果提醒方式：
扫码关注我们
