Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05749731 |
| Other study ID # |
LEF2106-2-47 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2020 |
| Est. completion date |
July 31, 2022 |
Study information
| Verified date |
February 2023 |
| Source |
Leiden University Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
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.
RECRUITMENT In principle, patients admitted for geriatric rehabilitation due to COVID-19
morbidity will be informed by letter and asked if they have objections that their regular
care data will be anonymously used for research purposes to improve practice in geriatric
rehabilitation. If they do, the data will not be used (opt-out procedure). In some countries
this will be conducted under the guidelines for service evaluation and audit, as it uses
routine data, held entirely by the clinical care team. Where this is not possible because of
local legislation or guidelines, informed consent will be obtained (opt-in procedure). During
one-year (October 2020 - November 2021), patients were enrolled in the study.
Participants will receive standard rehabilitation treatment according to the discretion of
clinical teams, which will likely be adapted to the specific needs of post-COVID-19 patients.
This treatment includes physical therapy, occupational therapy, and medical treatment by an
advanced nursing practitioner, geriatrician or medical specialist. This study will not
influence any therapy provided or decisions about the medical treatment or treatment programs
already used in the participating geriatric rehabilitation setting.
This study is observational and it is not anticipated that the observations will influence
therapy or treatment, particularly since such indices, questionnaires and measurements are a
regular part of the rehabilitation program.
STUDY MANAGEMENT For each participating geriatric rehabilitation facility in Europe one
instructed local care professional will complete an online CASTOR database in which anonymous
data from the clinical records of the included patients will be collected at admission,
discharge and 6 weeks and 6 months follow-up. For countries with multiple participating
sites, a country coordinator was appointed. Most country coordinators were the members of the
Special Interest Group Geriatric Rehabilitation of the EuGMS.
DATA COLLECTION Variables collected
- Demographic factors: In all participants, selected demographic factors such as year of
birth/age, gender, and residency premorbid will be documented.
- Information from hospital / general practitioner: hospital length of stay (days), ICU
length of stay (days), complications during hospital stay or at home (Thromboembolism,
Delirium, Pressure Ulcer), and COVID-19 diagnosis confirmed (PCR, Serology, clinically)
- At admission in geriatric rehabilitation: In all participants, only already routinely
collected data will be documented. Such as ADL (Barthel index), quality of life
(EQ-5D-5L), frailty (Clinical Frailty Scale), body mass index (BMI), nutritional status
(MNA/NRS/MUST/SNAQ65/..), comorbidity (wFCI (0-36 pts)), cognition (MMSE/Demtect/ MOCA))
, delirium (DOS/SQiD), mood/anxiety (/GDS/HADS), pressure ulcer (yes/no), fatigue
(VAS-scale), dyspnoea (VAS-scale), pain (NRS-P), mobility/balance (Timed Up and Go),
muscle strength (MRC biceps /quadriceps), and speech/swallowing problems (yes/no)
- At discharge from geriatric rehabilitation: At discharge information about: hospital
readmissions, length of stay in GR, discharge destination, ADL, frailty, BMI, nutrition,
cognition, mood/anxiety, fatigue, dyspnoea, pain, mobility/balance, muscle strength,
quality of life and complications during GR stay (Thromboembolism, Delirium, Pressure
Ulcer) will be documented. At discharge we will additionally collect information about
which professionals have been involved during geriatric rehabilitation an which
treatment interventions have been applied.
- Follow-up after discharge: At 6 weeks and 6 months follow-up, and if desirable at
flexible time points following regular care in the participating countries, we will
document: ADL, Quality of life, post-traumatic stress syndrome.
- Qualitative data about countries' GR care services and triage systems: country
coordinators in the study filled in a questionnaire about in what facility types GR for
post-COVID-19 patients is provided (e.g. nursing homes, skilled nursing facility, acute
care hospital ward, or on outpatient basis), which person refers the post-COVID-19
patients to GR (e.g. physician in the hospital, or GP), at which moment the referral
takes place, which patient characteristics the referral is based on (e.g. standardized
age cut-offs, frailty, multimorbidity, functional status, or psychosocial needs), which
formal assessment is used for GR referral decisions, additional selection criteria by
health insurance/policies, and criteria that need to be met by post-COVID patients for
discharge from GR.
Data checks Data checks were performed during data collection to prepare for the steering
board meetings that were held every two to three months with the country coordinators. In
order to stimulate the achievement of the sample size, numbers of patients included were
discussed during these meeting. Also structural missing or other remarkable things in the
data were discussed during these meetings. Local care professionals were made aware of other
missings or outliers in the data via email and asked to check and if possible complete or
correct these data.
Sample Size calculation The primary outcomes are ADL functioning (Barthel index or derived
from the USER or FIM) and quality of life (EQ-5D-5L). We performed a power calculation for a
paired sample t-test on the primary outcome ADL-functioning (Barthel index). We assume a
minimal clinically important difference of 2 points on the Barthel index as relevant, this is
the mean difference between Barthel score at admission and Barthel score at discharge. The
study would require a sample size of 52 (number of pairs) to achieve a power of 80% and a
level of significance of 5% (two sided), for detecting a mean of the differences of 2 between
pairs, assuming the standard deviation of the differences to be 5. We wanted to include a
minimum of 52 patients per country which was agreed by the special interest group SIG EuGMS
as being appropriate to generate the data we require. We aimed for a minimum of 250
participants in total.
STATSISTICAL ANALYSIS Different techniques will be used to analyze the data: Descriptive
statistics will be used to give an overview of characteristics of the participants in the
participating countries for all primary and secondary outcomes.
- For cross-country comparisons, we will perform a paired sample student t-test will be
used to test the difference between ADL functioning at admission and follow-up per
participating country, multilevel models will be built to model the recovery (in various
outcome measures) of patients over time per country, supplemented with qualitative data
about the countries' GR care services and triage systems.
- The course of recovery of post-COVID-19 patients over time (in various outcome measures)
will be modelled with multilevel unconditional growth models. These multilevel models
take into account that measurements are nested in patients and that patients are nested
in countries. In doing so, the model with the best fitting shape (e.g. linear or
quadratic) to our data will reveal the amount and speed of recovery.
- The impact of frailty on this course of recovery will be modelled, by adding the
variable for frailty measured by the clinical frailty scale (CFS) to the models for the
course of recovery.
- The impact of experiencing delirium during or prior to GR on this course of recovery
will be modelled, by adding the variable delirium (yes/no) to the models for the course
of recovery.
- (Potential) confounders of the impact of frailty on course of recovery and of the impact
of delirium on the course of recovery such as age, sex, frailty status, delirium, and
hospital stay, will be added to these
- By using descriptive statistics it will be described which post-COVID-19 GR patients
receive which therapies/interventions during GR, and/or which professionals are involved
in their GR trajectory.
No imputation will be used for missing data; complete case analysis will be performed, under
the assumption that the data is missing at random.
The level of significance will be set at p < 0.05.
