跳至主要内容
临床试验/NCT05749731
NCT05749731已完成不适用

Pan-European Study on Outcome and Service in Geriatric Rehabilitation in Times of COVID-19 Pandemic

Leiden University Medical Center50 个研究点 分布在 10 个国家目标入组 723 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
723
试验地点
50
主要终点
change in Activities of Daily Living (ADL)-functioning

研究概览

简要总结

Older and more vulnerable persons are more likely to get very ill when infected with the coronavirus, and have the highest COVID-19 morbidity and mortality rate. The majority of patients that are admitted to the hospital are older (>70 years), and some of them have been admitted to Intensive Care Units (ICU). In the case of rehabilitation of older patients post-COVID-19, we do not know what the course of recovery for these patients will be, and what treatment/approaches will deliver the best outcomes.

Persons that are recovering from a COVID-19 infection, and admitted on a geriatric ward for early rehabilitation, or geriatric rehabilitation ward or facility, can be included in the study. They will receive routine, usual care; participation in this study will not affect their rehabilitation care. Routine care data will be collected from their electronic patient files at admission to geriatric rehabilitation, and at discharge. This also includes some data about their premorbid status. In addition, study participants will be called six weeks and six months after discharge from rehabilitation and asked some questions about their recovery. There is no risk association with participation in this study. Data will be anonymously collected in an online database.

The primary aim of this study is to get insight into the course of recovery in (geriatric) rehabilitation patients affected by COVID-19 in Europe. Mainly, we are interested in functioning in activities of daily living (ADL-functioning) such as toileting, bathing, dressing, etc., and in quality of life. The second aim of this study is to get insight into the treatment modalities employed and the organization of geriatric rehabilitation that post-COVID patients in Europe receive. Therefore, we collect data on the types of care provided and the professionals involved. Moreover, we collect some patient characteristics such as year of birth, gender, date of admission and date of discharge; and data about complications such as delirium, pain, post-traumatic stress syndrome, hospital readmissions, and mortality. Our hypothesis is that most patients will show recovery during geriatric rehabilitation and in the six months after. However, we expect that the amount and/or speed of recovery will vary between patients.

详细描述

INTRODUCTION AND RATIONALE The COVID-19 pandemic has hit the world hard, and older and vulnerable persons are more likely to get very ill when infected, and have the highest morbidity and mortality. The majority of patients that are admitted to the hospital are older (>70 years), and some of them have been, or are being, admitted to Intensive Care Units. Many patients stay on the ICU/hospital for weeks. To get back to the highest state of functional independence, these patients will need specialised care and treatment, therefore geriatric rehabilitation will be very likely required.

Geriatric Rehabilitation (GR) is defined as a multidimensional approach of diagnostic and therapeutic interventions, the purpose of which is to optimise functional capacity, promote activity and preserve functional reserve and social participation "in older people with disabling impairments." The goal of geriatric rehabilitation has been defined as "to assist [older people] to manage personal activities of daily living without the assistance of another person. If this is not possible, the goal is to minimize the need for external assistance through the use of adaptive techniques and equipment." Thereby focussing on the amelioration of dependency in activities of daily living. However, we are still in the dark about the amount of functional recovery of geriatric post-COVID-19 patients. We do know from the first lessons from Italy, that the rehabilitation process is difficult, and the course is capricious.

Before being able to assure the best outcomes for older post-COVID geriatric rehabilitation patients, we first have to be informed about what the clinical characteristics are, what treatment is provided, and what outcomes geriatric post-COVID-19 patients have in geriatric rehabilitation. Therefore, members of the Special Interest Group Geriatric Rehabilitation of the European Geriatric Medical Society (EuGMS) decided to conduct this multi-center observational cohort study into usual care data on the course of functional and clinical outcomes in post-COVID-19 geriatric rehabilitation patients in several European countries.

OBJECTIVES The primary objective of this study to get insight into the course of functional and medical recovery in (geriatric) rehabilitation patients affected by COVID-19 in Europe. The secondary objective is to get insight into the treatment modalities employed and the organisation of geriatric rehabilitation that post-COVID patients in Europe receive.

The study was conducted according to the principles of the Declaration of Helsinki (2013 version) and in accordance with the General Data Protection Regulation (GDPR) and in full conformity to any applicable state or local regulations in the participating countries.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Recovering from a COVID-19 infection (confirmed with PCR, Serology, or clinically).
  • Indication for geriatric rehabilitation

排除标准

  • Presence of severe cognitive impairment, which leads to insufficient decisional capacities to participate in the study.
  • Subjects who have opted for not using their anonymous data for research purposes

结局指标

主要结局

change in Activities of Daily Living (ADL)-functioning

时间窗: Change in ADL-functioning from two weeks before admission to geriatric rehabilitation, until approximately 6 months after discharge from geriatric rehabilitation

The primary outcome measure is: ADL functioning. ADL functioning will be assessed with the Barthel Index (BI; scale 0-20 with 0 for complete dependence and 20 for optimal independence).

次要结局

  • change in Quality of Life (EQ-5D-5L)(Change in quality of life from admission to geriatric rehabilitation until approximately 6 months after discharge from geriatric rehabilitation)

研究者

发起方
Leiden University Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

mlhaaksma

Senior researcher

Leiden University Medical Center

研究点 (50)

Loading locations...

相似试验