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

基本信息

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
项目类别：
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

项目摘要

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) 患者是否接受目的地治疗机械循环支持 (DT MCS) 的人，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、心理和社交）从基线到术后 1 年的晚期心力衰竭患者，年龄为 60-80 岁。这项拟议研究的适当目标群体，因为他们正在接受 HT 和植入 MCS 设备更加频繁，尽管临床结果不佳的风险更大，但它们虽然研究已经检验了总体生存率，但很少有人考虑过。接受 HT 或 DT MCS 的老年少数患者的 HRQOL 可能是我提出的研究的一部分。通过告知老年少数晚期心力衰竭患者，有助于更好地以患者为中心的护理我将利用改善术后 HRQOL 的决策和指导策略。维持老年人生活质量的数据资源：心脏移植或机械移植支持吗？（SUSTAIN-IT）（国家老龄化研究所# R01AG047416，2015 年 7 月 15 日 – 21 年 3 月 31 日）。 SUSTAIN-IT 是一个多地点、观察性、前瞻性、纵向、比较有效性的项目我将使用一个理论框架来模拟疾病、治疗、指导本拟议研究的不良事件和症状。确定接受 DT MCS 的老年晚期心力衰竭患者与患者相比是否接受 HT（有或没有 MCS）的人的整体 HRQOL 发生非劣质变化（主要终点，使用针对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（白人与所有少数族裔）从基线到 1 第二个目的是确定种族是否是与手术后相关的危险因素。总体 HRQOL（使用堪萨斯城心肌病 12 心力衰竭特定问卷对于在 1 年时接受 DT MCS 和 HT 的患者，汇总评分作为因变量术后。