Profiling the Determinants of Recovery to Establish Novel Rehabilitation Guidelines to Improve Clinically Relevant and Patient-reported Outcomes in the Post-COVID-19 Period
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Post-COVID-19 Functional Status (PCFS) Scale
研究概览
简要总结
Currently, there are few studies that have been established that consist of a variety of established and coherent approaches that sought to profile the determinants of recovery, nor used interrogative procedures to understand lasting physical impairment. In this context, measurements obtained from an assessment of cardio-respiratory responses to physiological stress could provide an important insight regarding the integrity of the pulmonary-vascular interface and characterisation of any impairment or abnormal cardio-respiratory function [4]. Indeed, current approaches are being developed to support patients using previous knowledge from other acute respiratory infections (e.g. Acute Respiratory Distress Syndrome; ARDS and Middle Eastern Respiratory Syndrome; MERS), approaches that do not consider the novel challenges presented by COVID-19. The knowledge obtained from the proposed research plan will inform the development of COVID-19 specific rehabilitation and clinical management guidelines which can be implemented globally to increase patient wellbeing, physical capacity, and functional status which will be directly related national and international health and wellbeing, economical and societal impacts.
详细描述
3.1 Screening and Eligibility Assessment Study investigators will identify eligible participants within 72 hours of expected discharge from hospital. Eligibility will be determined using the criteria outlined which incorporates the Post-COVID-19 Functional Status (PCFS) Scale, a tool which has been developed and endorsed by the European Respiratory Society to measure functional status over time following COVID-19 infection. Patients graded 2, 3 or 4 on the PCFS will be eligible for participation. Eligible patients will be provided with a detailed explanation of the study including the provision of written information (PIS). Patients will be given time to consider participation in the research study before being approached again by the research team.
If the patient expresses an interest in study participation the research team will invite participants to a baseline data collection session that will be held at the University of Derby in the days following discharge.
3.2 Assessments: Upon enrolment, admission clinical data and the results of investigations undertaken as part of the participants' usual care, before study enrolment will be collected, as outlined below. In the days following discharge (2 +/- 2 days) participants will complete a baseline assessments and measurements, outlined below and in the schedule of procedures.
At days 14, 42, 70, 98 (+/- 2 days) participants will conduct a consultation via telephone where all scales and questionnaires completed at baseline will be repeated (see the schedule of procedures outlined below). The total duration of these consultations' will be 15 minutes each time.
At Days 28, 56, 84, 112, 140 and 168 (+/- 2 days) participants will be attend a face to face appointment at the University of Derby's Human Performance Unit where physiological, biological, cognitive, and patient-reported outcome measures will be completed (see the schedule of procedures outlined below).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged >18 years, including immunocompromised patients
- •Admitted to hospital for treatment for mild/moderate COVID-19 (from NLR and PLR ratios and grade 2, 3 or grade 4 using PCFS Scale).
- •Chest radiograph/CT scan consistent with COVID-19 infection.
- •Able to understand verbal or written information in English
排除标准
- •Below 18 years of age
- •No confirmed diagnosis of COVID-
- •Achieving a grade 0 or 1 on the PCFS.
- •Not admitted to hospital/critical care for treatment of COVID-
- •Reduced or lack of mental capacity
- •Not able to understand verbal or written information in English
结局指标
主要结局
Post-COVID-19 Functional Status (PCFS) Scale
时间窗: 16 weeks
The PCFS offers the full spectrum of functional outcomes, and focuses on both limitations in usual duties/activities and changes in lifestyle in six scale grades.
次要结局
- EQ-5D-5L(16 weeks)
研究者
Mark Faghy
Senior Lecturer in Exercise Physiology
University of Derby