The Impact of Race on Quality of Life of the Aged after Heart Transplant or Destination Therapy Mechanical Support

种族对心脏移植或目的地治疗机械支持后老年人生活质量的影响

• 批准号: 10282497
• 负责人: Jerian Dixon-Evans
• 金额: $ 6.94万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10282497
• 关键词: Address; Adult; Adverse event; Affect; African American; Age; Age-Years; Aging; Alaska Native; American Indians; Asians; Cardiac Surgery procedures; Cardiology; Cardiomyopathies; Cities; Clinical; Death Rate; Decision Making; Destinations; Devices; Disease; Ethnic Origin; Hawaiian population; Heart Transplantation; Heart failure; Implant; Incidence; Inequality; Interagency Registry for Mechanically Assisted Circulatory Support; Kansas; Knowledge; Literature; Mechanics; Medical; Minority; Modeling; National Institute on Aging; Operative Surgical Procedures; Outcome; Pacific Island Americans; Participant; Patient-Centered Care; Patients; Population; Postoperative Period; Preparation; Prevalence; Procedures; Psyche structure; Quality of life; Questionnaires; Race; Reporting; Research Personnel; Research Project Grants; Resources; Risk; Risk Factors; Site; Survival Rate; Symptoms; Time; Training; Transplant Recipients; Transplantation; aged; comparative effectiveness study; data resource; experience; health difference; health disparity; health related quality of life; improved; interest; left ventricular assist device; middle age; primary endpoint; prospective; racial difference; social

The purpose of this study is to determine whether older advanced heart failure (HF) patients who undergo destination therapy mechanical circulatory support (DT MCS), as compared to patients who undergo heart transplantation (HT), experience non-inferior change in overall health-related quality of life (HRQOL) and HRQOL domains (physical, mental, and social) by race from baseline to 1 year post-operatively. Advanced HF patients, 60-80 years of age, are an appropriate target group for this proposed study because they are receiving HTs and implant of MCS devices more frequently, and despite a greater risk for poor clinical outcomes, they have acceptable rates of survival. While studies have examined overall survival, few have considered HRQOL of older minority patients who undergo HT or DT MCS. MY proposed study may contribute to better patient-centered care of older minority advanced HF patients, by informing decision making and guiding strategies to enhance post-operative HRQOL. I will leverage the data resources of Sustaining Quality of Life of the Aged: Heart Transplant or Mechanical Support? (SUSTAIN-IT) (National Institute on Aging # R01AG047416, 7/15/15 – 3/31/21). SUSTAIN-IT is a multi-site, observational, prospective, longitudinal, comparative effectiveness study. I will use a theoretical framework which models the influence of disease, treatment, adverse events, and symptoms on HRQOL to guide this proposed study. The primary aim is to determine whether older advanced HF patients who undergo DT MCS, as compared to patients who undergo HT (with or without MCS) experience non-inferior change in overall HRQOL (primary endpoint, using the heart failure-specific Kansas City Cardiomyopathy-12 questionnaire summary score), and HRQOL domains by race (white versus all minorities) from baseline to 1 year post-operatively. The secondary Aim is to determine whether race is a risk factor related to overall HRQOL (using the Kansas City Cardiomyopathy-12 heart-failure specific questionnaire summary score as the dependent variable), for patients who undergo DT MCS and HT at 1 year post-operatively.

本研究的目的是确定老年晚期心力衰竭(HF)患者 接受目的地治疗机械循环支持(DT MCS)的患者与 接受心脏移植(HT)的患者总体上经历了非劣质的变化 健康相关生活质量(HRQOL)和HRQOL领域(身体、心理和社会) 从基线到术后1年的比赛。60-80岁的晚期心力衰竭患者是 适合这项拟议研究的目标群体，因为他们正在接受HTS并植入 MCS设备更频繁，尽管临床结果较差的风险更大，但它们 可接受的存活率。虽然研究检查了总体存活率，但很少有人考虑到 老年少数民族患者接受高龄低血压和低血压治疗后的HRQOL。我提议的研究可能 通过告知以下信息，有助于更好地以患者为中心护理老年少数民族晚期心衰患者 提高术后HRQOL的决策和指导策略。我将利用 老年人维持生活质量的数据来源：心脏移植还是机械移植 支持？(维系信息技术)(国家老龄研究所#R01AG047416，7/15/15-3/31/21)。 持续-IT是一种多站点、观察性、前瞻性、纵向、相对有效性 学习。我将使用一个理论框架来模拟疾病、治疗、 不良事件和HRQOL症状，以指导这项拟议的研究。其主要目的是 确定接受DT MCS的老年晚期心衰患者是否与患者相比 接受高血压(伴或不伴MCS)的患者在总体HRQOL中经历了非劣质的变化 (主要终点，使用特定于心力衰竭的堪萨斯城心肌病-12问卷 总分)，以及按种族划分的HRQOL领域(白人对所有少数族裔)，从基线到1 术后一年。第二个目的是确定种族是否是与 总体HRQOL(使用堪萨斯城心肌病-12心力衰竭特定问卷 以总分为因变量)，适用于1年后接受DT MCS和HT的患者 手术后。