Evaluating a Comprehensive Multimodal Outpatient Rehabilitation Program to Improve the Functioning of Persons Suffering from Post-acute Sequelae of SARS-CoV-2 infection (PASC): A Randomized Controlled

评估综合多模式门诊康复计划以改善 SARS-CoV-2 感染急性后遗症患者的功能 (PASC)：一项随机对照研究

• 批准号: 10583969
• 负责人: TIMOTHY R DILLINGHAM
• 金额: $ 69.63万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-12 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10583969
• 关键词: 2019-nCoV; Address; Advisory Committees; Aerobic; Anxiety; Breathing; COVID-19; COVID-19 severity; COVID-19 survivors; COVID-19 vaccine; Caring; Clinic; Clinical; Cognition; Cognitive remediation; Consensus; Contracts; Data; Diagnosis; Diffusion; Disease; Educational Materials; Effectiveness; Effectiveness of Interventions; Enrollment; Fatigue; Growth; Guidelines; Health; Health system; Incidence; Individual; Infection; Inpatients; Intervention; Longitudinal Surveys; Measures; Mental Depression; Muscle; Neuropsychology; Outcome; Outpatients; Pain; Patient Care; Patient Education; Patients; Persons; Policies; Policy Developments; Population; Post-Acute Sequelae of SARS-CoV-2 Infection; Program Development; Psyche structure; Randomized; Randomized, Controlled Trials; Recommendation; Recovery; Rehabilitation therapy; Reporting; Research; Resistance; Respiratory Diaphragm; SARS-CoV-2 infection; SARS-CoV-2 negative; SARS-CoV-2 positive; Sampling; Self Management; Severities; Social Functioning; Standardization; Stress; Stretching; Surveys; Survivors; Symptoms; Syndrome; System; Testing; Time; Titrations; Vaccinated; Vaccines; Variant; Virus; Work; acute infection; acute symptom; cognitive function; conditioning; coronavirus disease; cost; cost comparison; cost effective; cost effectiveness; cost estimate; effectiveness evaluation; effectiveness testing; evidence base; experience; flexibility; functional improvement; functional restoration; group intervention; improved; improved outcome; intervention cost; intervention effect; long-term sequelae; multidisciplinary; multimodality; patient oriented; persistent symptom; pilot trial; post-COVID-19; prevent; primary outcome; programs; psychologic; reduce symptoms; rehabilitative care; secondary outcome; severe COVID-19; symptom management; treatment as usual; trial design; walking speed

About 10-20% of persons who contract SARS CoV-2 will experience persistent post-acute sequelae of SARS- CoV-2 infection (referred here as PASC). Given that persistent symptoms are heterogeneous with multisystem involvement, recent consensus recommendations suggest that a holistic rehabilitation program may be required to manage PASC and restore function. While treatments offered at emerging outpatient COVID recovery clinics are being informed by previous similar diseases, the need is great for a better understanding of the unique needs of this growing population and for tested, efficacious rehabilitation programs to address them. We provide both here. Specifically, our aims are: (1) To quantify the incidence and severity of PASC across different variants and their effects on health and functioning; (2) To develop and evaluate the effectiveness of a patient-centered, interdisciplinary, multimodal comprehensive rehabilitation program among patients with PASC; and (3)To estimate the costs associated with the proposed PASC rehabilitation intervention and to examine the relationship between intervention’s costs and effectiveness and their implication for rehabilitation program initiatives. Data from a large and diverse ongoing longitudinal survey of persons who tested for COVID-19 at the study health system will serve as the sampling frame from which to identify and enroll PASC patients in the study. The targeted six-week program will be comprised of a core set of therapies, including individually titrated stretching and flexibility, strengthening of accessory breathing muscles and diaphragm, resistance and aerobic conditioning, and vestibular rehabilitation, supplemented by neuropsychological and cognitive remediation tailored to patients’ needs. Using a randomized controlled trial (RCT) design, the effectiveness of the intervention will be compared to that of usual care augmented by a one- time in-person assessment and patient education materials. In addition to walking speed, a widely used global measure of aerobic capacity and endurance, and patient-reported health and functioning (primary outcomes), we will assess the intervention effectiveness on: (i) cognitive functioning, (ii) pain, (iii) fatigue, (iv) tension, stress, anxiety, and depression, and (v) self-management of PASC symptoms (secondary outcomes). Outcomes will be measured at fixed points in time at 8 weeks (shortly after therapy completion) and at 90 day’s post- study entry to examine sustainability of effects. Our overarching hypothesis is that that higher intervention costs in the intervention group will be more than offset by greater improvements in outcomes implying that, overall, persons in the intervention group will receive more cost-effective care than those in usual care group. Given the dearth of rigorous scientific evidence regarding effective assessment and treatment of PASC and the unresolved questions concerning access to and value of post-COVID rehabilitation care, the results of this study will have significant implications for both policy and program development.

大约 10-20% 的 SARS CoV-2 感染者会经历持续的 SARS 急性后遗症—— 鉴于持续症状在多系统中具有异质性，因此 CoV-2 感染（此处称为 PASC）。 参与，最近的建议共识表明，整体康复计划可能是 需要管理 PASC 和恢复功能，同时在新出现的门诊新冠患者中提供治疗。 康复诊所正在了解以前的类似疾病，因此非常需要更好地了解 这一不断增长的人口的独特需求以及经过考验的、有效的康复计划来解决 具体而言，我们的目标是：(1) 量化 PASC 的发生率和严重程度。 (2) 制定并评估 以患者为中心、跨学科、多模式综合康复计划的有效性 PASC 患者；以及 (3) 估算与拟议的 PASC 康复相关的费用 干预措施，并检查干预措施的成本和效果及其效果之间的关系 对康复计划举措的影响。数据来自一项大规模且多样化的持续纵向调查。 在研究卫生系统中接受过 COVID-19 检测的人员将作为抽样框架，从中进行 确定 PASC 患者并将其纳入研究中，为期六周的目标计划将由一组核心组成。 治疗方法，包括单独调整拉伸和灵活性、加强辅助呼吸 肌肉和膈肌、阻力和有氧调节以及前庭康复，辅以 根据患者的需求进行神经心理学和认知治疗。 （RCT）设计中，干预措施的有效性将与通过一项增强的常规护理进行比较 除了步行速度之外，还有全球广泛使用的时间亲自评估和患者教育材料。 有氧能力和耐力的测量，以及患者报告的健康和功能（主要结果）， 我们将评估干预效果：(i) 认知功能，(ii) 疼痛，(iii) 疲劳，(iv) 紧张， 压力、焦虑和抑郁，以及 (v) PASC 症状的自我管理（次要结果）。 将在 8 周（治疗完成后不久）和 90 天的固定时间点测量结果 我们的首要假设是，研究后的结果是更高的。 干预组的干预成本将被结果的更大改善所抵消 这意味着，总体而言，干预组中的人将比平常人获得更具成本效益的护理 鉴于缺乏有关有效评估和治疗的严格科学证据。 PASC 以及有关获得新冠肺炎后康复护理的机会和价值的未解决问题， 这项研究的结果将对政策和方案的制定产生重大影响。