The development and validation of a scale to measure Treatment Regimen Fatigue among older adults living with HIV

摘要 这项申请是对PAR-21-068关于艾滋病毒/艾滋病和老龄化以及鼻炎的多学科研究的回应 (NOT-OD-21-100)提高患者对治疗和预防方案的依从性。到2030年，年龄更大(老龄化 50年以上)艾滋病毒携带者(PLWH)将占所有PLWH的73%。尽管艾滋病毒治疗取得了进展， 与没有感染艾滋病毒的同龄人相比，老年PLWH的早期发病率和死亡率仍处于较高的风险，原因是 艾滋病毒疾病、多发病和生物心理社会挑战对疾病管理的累积影响。 治疗方案/疾病特异性疲劳(TRDF)-与生活、管理或应对相关的痛苦 慢性病、其症状和/或治疗--是人们进行疾病管理的关键障碍 患有慢性病。以前的研究估计，TRDF影响了所有PLWH的33%-65%。真正的价值， 然而，由于没有全面、可靠和有效的工具来评估，因此这些问题是未知的。我们的大部分TRDF 知识来自1)用单一项目评估TRDF的研究；2)来自年轻人的定性数据， 更健康 PLWH； 3)没有完全捕获TDRF及其定义特征的工具，如不平衡 患者工作量和患者容量之间的关系；以及4) 数据来自在单身出现之前进行的研究- 片剂疗法。 一个全面的TRDF工具将使我们能够确定TDRF的可修改驱动因素 开展流行病学监测，为老年评估提供信息，指导干预措施的发展。引导式 通过集成工作负荷能力模型和累积复杂性理论的新概念模型， 在我们前期工作的基础上， 本研究的目标是设计并验证 全面的评估工具 TRDF，并确定可修改的因素，以促进讲英语和西班牙语的老年患者的治疗 TRDF 在患有多发病的老年PLWH中，为了完善我们的新概念模型，建议TRDF之间的联系 以及不良的临床结果，包括艾滋病毒治疗中断和未受抑制的病毒血症。在那些有 多发病，观察到共生条件自我管理能力差的证据(S)(例如，高A1C 和/或最近一次就诊时血压升高)在报告疾病工作量较大和较低的人中 容量。对HIV临床医生的采访表明，老年PLWH可能比其他人更容易感染TRDF 年轻的PLWH，临床医生报告缺乏关于TRDF的知识和资源。我们的发现 重点 PLWH合并多发病。从我们的混合方法研究中获得的初步数据，以获得关于 迫切需要开发一种工具来评估老年PLWH中的TRDF，并帮助临床医生 确定以人为中心的干预措施，以减轻其对疾病管理的影响。要做到这一点，我们将 利用以前工作中的辅助数据为我们的TRDF的英语和西班牙语版本的设计提供信息 仪器(目标1A)，然后我们将进行预试(目标1B。然后，我们将进行心理测量研究，以验证 两个版本都使用了严格的调查开发方法，并测试了我们的新概念模型(目标2)。

ABSTRACT This application is in response to PAR-21-068 Multidisciplinary Studies of HIV/AIDS and Aging, as well as NOSI (NOT-OD-21-100) Improving Patient Adherence to Treatment and Prevention Regimens. By 2030, older (aged 50+ years) people living with HIV (PLWH) will comprise 73% of all PLWH. Despite advances in HIV treatment, older PLWH remain at elevated risk for early morbidity and mortality compared to their peers without HIV due to the cumulative impact of HIV disease, multimorbidity, and biopsychosocial challenges on disease management. Treatment regimen/disease-specific fatigue (TRDF)—distress associated with living with, managing, or coping with a chronic condition, its symptoms and/or treatments—is a key barrier to disease management among people with chronic conditions. Previous studies estimate that TRDF impacts 33-65% of all PLWH. True values, however, are unknown, as there is no comprehensive, reliable, and valid tool to assess it. Much of our TRDF knowledge is derived from 1) studies assessing TRDF with single items; 2) qualitative data from younger, healthier PLWH; 3) tools that do not fully capture TDRF and its defining characteristics, such as imbalance between patient workload and patient capacity; and 4) data from studies conducted prior to the advent of single- tablet regimens. A comprehensive TRDF tool would enable us to identify modifiable drivers of TDRF that could enable epidemiologic surveillance, inform geriatric assessments, and guide intervention development. Guided by our novel conceptual model integrating the Workload Capacity Model and Cumulative Complexity Theory and building on our preliminary work, the goal of this study is to design and validate a comprehensive tool to assess TRDF and identify modifiable factors to facilitate its treatment among older English- and Spanish-speaking TRDF among older PLWH with multimorbidity and to refine our novel conceptual model suggest links between TRDF and poor clinical outcomes, including HIV treatment interruption and unsuppressed viremia. Among those with multimorbidity, evidence of poor self-management of the co-occurring condition(s) was observed (e.g., high A1C and/or elevated blood pressure at most recent visit) among those reporting greater disease workload and lower capacity. Interviews with HIV clinicians suggested that older PLWH may be more susceptible to TRDF than younger PLWH, and clinicians reported a lack of knowledge and resources regarding TRDF. Our findings highlight PLWH with multimorbidity. Preliminary data from our mixed methods study to elicit information about an urgent need to develop a tool to assess TRDF among older PLWH and assist clinicians with identifying person-centered interventions to mitigate its effects on disease management. To do this, we will leverage secondary data from previous work to inform the design of English and Spanish versions of our TRDF instruments (Aim 1A), which we will then pre-test (Aim 1B. We will then conduct a psychometric study to validate both versions using rigorous survey development methods, and test our novel conceptual model (Aim 2).