Addressing Inactive Kidney Transplant Waitlist Status through Adapting a Tailored Psycho-Social-Environmental Program

通过调整定制的心理社会环境计划来解决不活跃肾移植等候名单的问题

• 批准号: 10664169
• 负责人: Melissa Hladek
• 金额: $ 19.33万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-01 至 2028-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10664169
• 关键词: Address; Admission activity; Affect; Age; American; Behavior Therapy; Caring; Cohort Studies; Communities; Complement; Development; Dialysis procedure; Disparity; Education; Elderly; Elements; End stage renal failure; Enrollment; Environment; Equity; Evidence based intervention; Fatigue; Funding; Future; Goals; Healthcare; Heterogeneity; Home; Home environment; Hospitalization; Individual; Internet; Intervention; Interview; Kidney Transplantation; Letters; Low income; Mental Depression; Mentors; Mentorship; Modeling; Nurses; Nursing Homes; Occupational Therapist; Outcome; Pain; Participant; Patient-Focused Outcomes; Patients; Persons; Phase; Physical Function; Population; Procedures; Quality of life; Randomized; Reporting; Research; Risk; Self Efficacy; Self Management; Services; Social Network; Social isolation; Social support; Stress; Surgical complication; Symptoms; Telemedicine; Time; Training; Transplantation; Voting; Vulnerable Populations; Waiting Lists; Work; aging in place; control trial; depressive symptoms; design; disability; efficacy trial; evidence base; experience; feasibility testing; functional improvement; functional independence; health literacy; human centered design; improved; low health literacy; member; mortality; mortality risk; multidisciplinary; novel; open label; participant interview; patient portal; personalized approach; pilot test; primary outcome; programs; prospective; prototype; psychosocial; recruit; reduce symptoms; social culture; social engagement; transplant centers; transplant model

PROJECT SUMMARY/ ABSTRACT Kidney transplantation (KT) is a growing treatment for older adults with end-stage renal disease (ESRD), but there is vast heterogeneity in KT outcomes. Older adults are more likely to be listed as inactive (on the waitlist but ineligible for KT), which is associated with increased waitlist mortality and worse post-surgical outcomes. Those awaiting KT also experience depressive symptoms, pain, loss of physical function, and social isolation, which can contribute to waitlist mortality and decrease chances of KT. As of April 2022, 94,249 people were awaiting KT with an estimated 44% currently inactive. There is a critical need for enhanced models of care to improve inactive waitlist outcomes. The purpose of this study is to adapt and pilot test the evidence-based Community Aging in Place- Advancing Better Living for Elders (CAPABLE) intervention to address barriers for KT waitlist activation which involve symptom burden, self-management, social support, health literacy, patient activation and home function. CAPABLE equips older adults to age in their homes using person-directed priorities and a strengths-based tailored approach by a nurse, occupational therapist and handy worker (PI: Szanton, co-primary mentor). CAPABLE improves function, pain, depressive symptoms, and quality of life while decreasing hospitalizations and nursing home admissions. CAPABLE also improves healthcare engagement and self-efficacy which are key components to remaining active on the KT waitlist. Our adapted CAPABLE–Transplant model will extend services to include options for internet access, training, patient portal usage and patient-directed online social engagement to address the noted isolation. We hypothesize that decreasing patient and clinician reported barriers will decrease time inactive on the KT waitlist status. We plan to examine CAPABLE-Transplant among those with inactive KT waitlist status in a two-phase developmental study leveraging partnership with the JHU Comprehensive Transplant Center and an ongoing, prospective NIA R01-funded cohort study of individuals awaiting KT for recruitment (PI: McAdams-DeMarco, co-primary mentor) through the following aims: (1) To develop an adaptation of CAPABLE targeting those currently KT inactive, (2) To iteratively refine the CAPABLE -Transplant prototype for those currently KT inactive and, (3) To pilot test the CAPABLE-Transplant intervention in a 30 person 1:1 randomized waitlist control trial delivered over 16 weeks with outcomes (e.g. waitlist status, symptom burden, social networks) evaluated at 0,16, and 32 weeks post-randomization to test feasibility, acceptability, fidelity of CAPABLE-Transplant and estimate preliminary effects sizes for a future efficacy trial. To our knowledge, there are no other home-based programs that address patient-directed goals and the home environment among those inactive awaiting KT. This work will form the basis for a future R01 to expand to other KT centers and/or into other transplant populations conducting a larger community-based, efficacy trial.

项目总结/摘要 肾移植（KT）是一种治疗老年终末期肾病（ESRD）的方法，但 KT结果存在巨大的异质性。老年人更有可能被列为不活跃（在等待名单上 但不适合接受KT），这与等待名单死亡率增加和手术后结局更差相关。 那些等待KT的人也会经历抑郁症状，疼痛，身体功能丧失和社会孤立， 这可能导致等待名单死亡率并降低KT的机会。截至2022年4月， 等待KT，估计有44%目前不活跃。迫切需要加强护理模式， 改善不活跃等待名单结果。本研究的目的是适应和试点测试的证据为基础的 社区老龄化的地方-推进更好的生活为老年人（能力）干预，以解决障碍， KT等候名单激活涉及症状负担、自我管理、社会支持、健康素养、患者 激活和主页功能。能够装备老年人年龄在他们的家中使用个人指导 由护士、职业治疗师和勤杂工（PI： Szanton，co-primary mentor）. CAPABLE改善功能、疼痛、抑郁症状和生活质量 同时减少住院和疗养院的入院人数。能力也改善了医疗保健 参与度和自我效能感，这是在KT候补名单上保持活跃的关键组成部分。我们的适应 CAPABLE-移植模型将扩展服务，包括互联网接入，培训，患者门户网站 使用和患者导向的在线社交参与，以解决注意到的隔离。我们假设 减少患者和临床医生报告的障碍将减少KT等待列表状态上的非活动时间。我们计划 在两个阶段的发展中，在非活动KT等待名单状态的患者中检查CAPABLE移植 研究利用与JHU综合移植中心和正在进行的前瞻性NIA的合作伙伴关系 R 01资助的等待KT招募的个体队列研究（PI：McAdams-DeMarco，联合主要研究） （1）制定一个适应能力，以目前的KT （2）迭代地完善那些目前KT不活跃的CAPABLE -移植原型，以及（3） 在一项30人1：1随机等待名单对照试验中对CAPABLE-移植干预进行初步测试， 超过16周，结局（例如，等待名单状态、症状负担、社交网络）评价为0、16和32 随机化后6周，以检验CAPABLE-移植的可行性、可接受性、保真度和估计值 为将来的疗效试验提供初步的效应量。据我们所知，没有其他家庭项目 在那些等待KT的非活动人群中，解决以患者为导向的目标和家庭环境。这项工作 将成为未来R 01扩展到其他KT中心和/或其他移植人群的基础 开展一项更大规模的社区疗效试验。