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.

约10-20%感染SARS CoV-2的人会出现持续的SARS急性期后后遗症- CoV-2感染（简称PASC）。考虑到持续性症状是异质性的， 参与，最近的共识建议表明，一个整体的康复计划可能是 管理PASC和恢复功能所需的。虽然新出现的门诊COVID提供的治疗 康复诊所正在了解以前的类似疾病，需要更好地了解 这一不断增长的人口的独特需求，并为测试，有效的康复计划，以解决 他们我们在这里提供两者。具体而言，我们的目标是：（1）量化PASC的发病率和严重程度 （2）开发和评估不同的变体及其对健康和功能的影响; 以患者为中心的跨学科多模式综合康复计划的有效性 PASC患者;（3）估计与建议的PASC康复相关的费用 干预，并审查干预的成本和效果之间的关系， 对康复计划倡议影响。数据来自一项正在进行的大规模和多样化的纵向调查， 在研究卫生系统进行COVID-19检测的人员将作为抽样框架， 在研究中识别并招募PASC患者。有针对性的六周计划将包括一个核心集 治疗，包括个别滴定拉伸和灵活性，加强辅助呼吸 肌肉和横膈膜，阻力和有氧调节，前庭康复，辅以 神经心理学和认知补救适合患者的需求。使用随机对照试验 (RCT)设计，干预的有效性将被比较，以增加一个- 时间在人的评估和病人的教育材料。除了步行速度，一个广泛使用的全球性的 有氧能力和耐力的测量，以及患者报告的健康和功能（主要结局）， 我们将评估干预对以下方面的有效性：（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（次要结局）。 将在8周（治疗完成后不久）和90天的固定时间点测量结局 研究后进入，以检查影响的可持续性。我们的首要假设是， 干预组的干预成本将被结果的更大改善所抵消 这意味着，总的来说，干预组的人将获得比普通组更具有成本效益的护理， 关怀小组鉴于缺乏关于有效评估和治疗的严格科学证据， PASC和尚未解决的问题，有关获得和价值的COVID后康复护理， 这项研究的结果将对政策和方案的制定产生重大影响。