Official Title
Patients´ Mental and Physical Health After Being Treated for Covid-19 in an Intensive Care Unit in Sweden, a National Register Study
Brief Summary

Covid-19 is a disease where both clinical experience and thus knowledge about thelong-term effects of the disease are currently sparse. However, current follow-up resultsindicate a more pronounced cognitive and respiratory impairment than previously seen in anormal ICU population. As we know that the prevalence of impairments in neurocognitiveand Health Related Quality of Life (HRQoL) is increased in a majority of ICU patients, itwould be of benefit to gain knowledge about the impact on the recovery trajectory forpatients treated for Covid-19, and to increase the understanding of which factors thataffect the HRQoL and recovery and in what way these differs between patients treated inICU for Covid-19 and other causes respectively. This can contribute to better structuresfor follow-up and possibility to individualisation that better address which patients arein risk for decreased HRQoL and where benefit for the patient, health care and socialeconomic can be achieved.

Detailed Description

Introduction During 2020, an infection disease caused by the new coronavirus Sars-Cov2,
Covid-19 were globally spread in the world. Covid-19 caused extensive consequences to the
society, economy, and health care. In some of the patients the symptoms progressed to a
life-threatening respiratory failure whit a need for intensive care. The intensive care
was complicated then the progress of the disease was not followed the usual care for
patients with difficult respiratory disease. Many of the patients with Covid-19 required
deeper sedation with high-doses of anaesthesia and muscle relaxants and long time in
ventilator. This is not in line with the current evidence regarding ventilator treatment
and sedation in intensive care and for considered to constitute risk-factors for
intensive care related residuals symptoms and worsened long-time results as well as
increased mortality. In addition, the hospitals had restrictions regarding visitors and
the relatives were not allowed to visit patients at the Intensive Care Unit (ICU). The
presence of relatives is estimated in intensive care patients as one of the most
important factors contributing to their recovery.

Today we know that intensive care patients had a risk to get physical, mental, and
cognitive problems long time after hospital discharge. Other common residual problems as
anxiety, depression, and post-traumatic stress (PTSD) can also occurred after intensive
care. However, there are an increased risk that ICU patients with Covid-19 experience
physical, and mental problems and decreased health related quality of life (HRQoL), then
the environment at ICU during the Covid-19 pandemic, could predispose for cognitive
failure and PTSD. The knowledge about this is limited. Today, data indicate that fatigue
and dyspnoea are common residual symptoms which affect the HRQoL in multiple dimensions
long time after hospital discharge.

Since 2005 the Swedish Intensive Care Registry (SIR) recommend to follow-up former ICU
patients HRQoL (RAND-36), BMI, ADL and working capacity. We have now a unique chance to
describe how patients taken care for Covid-19 in ICU experience their HRQoL with
physical, mental, and cognitive problems compared to patients who were cared for in ICU
for reasons other than Covid-19, and if they changed over time in relation to changed
treatment conditions. It is important to map which risk factors that affect patients
HRQoL. International studies show that factors important to HRQoL after intensive care
are: age, comorbidity, the severity of the illness, length of stay, diagnose, PTSD, and
symptoms of depression. It is likely that other factors also play a decisive role, such
as socioeconomics factors. The purpose of this study is to deepen the analyse and
identify other factors that are important for the patients HRQoL.

Aim The aim is to increase the knowledge about adult patient's whit Covid-19 taken care
of at ICUs in Sweden estimate their HRQoL during the first year after ICU discharge and
compare their HRQoL with patients taken care at ICU for other reasons than Covid-19 and
which risk-factors affect the HRQoL and if there are any discrepancy between the groups.

Research-questions Are there differences in self-estimated HRQoL between patients care
for Covid-19 and patients cared for other reasons at ICU, at 3, 6 and 12 months after ICU
discharge? Method Design: National quality register study. Participants/sample size: All
adult patients ≥18 year who have been treated at ICUs in Sweden and have a registered
follow-up in SIR. (Covid-19 and non-Covid-19).

Data Collection:

Anonymous data collected from the Swedish intensive quality register (SIR), the national
patient register in the National board of health and welfare, and the Statistics Sweden
(SBC) LISA register for patients cared for in ICU and how have a registered RAND-36 in
SIR. The Covid-19 group include patients cared in ICU between 01-03-2020 and as long as
the pandemic is ongoing. The non-Covid-19 group includes patients how have been cared in
ICU 01-01-2017 until 31-12-2019, before the outbreak of the pandemic to get the best
comparing data. The reasons to include data from SIR are 1) to reduce the effort for the
patients, to fill in more questionnaires and 2) that the time before outbreak of Covid-19
is more valid to compare with then the intensive care during the Covid-19 pandemic have
to deviate from their usual regimen regarding care and treatment as well as the selection
of patients and a comparison during the Covid period therefore has a risk of bias Data
analysis Data compiled on group-level and to be used to compare between the groups.
Quantitative methods are used to describe tendances in the group and analysis of
differences between the groups. Data regarding demography and comorbidity analysis
descriptively at group level.

Association is investigated with correlation and regression analysis, t-test or
corresponding.

Comparison between the groups is done with t-test parametric data and Mann-Whitney
non-parametric variables. Identifying of factors influencing the outcome of RAND-36
(HRQoL) is done with univariate regression analysis. Values with significant outcomes are
further analysed with multivariate regression analysis for identification of independent
risk factors versus outcomes in RAND-36 (HRQoL). The results of variate analysis reports
as OR.

Active, not recruiting
Quality of Life
Intensive Care Unit Syndrome
Eligibility Criteria

Inclusion Criteria:

Consecutively admitted ICU patients with a completed RAND-36 follow-up form

Exclusion Criteria:

-

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Sweden
Locations

The Swedish Intensive Care Registry
Karlstad, Sweden

Sten Walther, PhD, Study Chair
Linkoping University

Swedish Intensive Care Registry
NCT Number
Keywords
COVID 19
MeSH Terms
COVID-19