Quality of LifeNCT06042790
Patients´ Mental and Physical Health After Covid-19 Treated in ICU in Sweden
An observational study of Quality of Life and Intensive Care Unit Syndrome, run by Swedish Intensive Care Registry at 1 site in Sweden.
Trial summary
Covid-19 is a disease where both clinical experience and thus knowledge about the long-term effects of the disease are currently sparse. However, current follow-up results indicate a more pronounced cognitive and respiratory impairment than previously seen in a normal ICU population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Intensive Care Unit Syndrome
- How many people
- 2,500 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2020to 8 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Group I ICU patients with Covid-19 Group II ICU patients without Covid-19
Who may be able to join
- Consecutively admitted ICU patients with a completed RAND-36 follow-up form
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patients´ Mental and Physical Health After Being Treated for Covid-19 in an Intensive Care Unit in Sweden, a National Register Study
Covid-19 is a disease where both clinical experience and thus knowledge about the long-term effects of the disease are currently sparse. However, current follow-up results indicate a more pronounced cognitive and respiratory impairment than previously seen in a normal ICU population. As we know that the prevalence of impairments in neurocognitive and Health Related Quality of Life (HRQoL) is increased in a majority of ICU patients, it would be of benefit to gain knowledge about the impact on the recovery trajectory for patients treated for Covid-19, and to increase the understanding of which factors that affect the HRQoL and recovery and in what way these differs between patients treated in ICU for Covid-19 and other causes respectively. This can contribute to better structures for follow-up and possibility to individualisation that better address which patients are in risk for decreased HRQoL and where benefit for the patient, health care and social economic can be achieved.
Read the 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.
- Conditions
- Quality of Life, Intensive Care Unit Syndrome
- Keywords
- Covid 19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Covid-19 ICU patients | Patients with confirmed Covid-19 admitted to ICU care | |
| non-Covid-19 patients | Non Coivd-19 patients admitted to ICU before 2020 |
What is being measured
The primary outcome is the main question the study is designed to answer.
HRQoL
RAND-36
Measured: 2, 6, 12 months post ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Mar 2020
- Primary completion8 Aug 2022
- Study completion8 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swedish Intensive Care Registry
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sten Walther, Swedish Intensive Care Registry
- Investigators
- Sten Walther, PhD, Study chair, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06042790
- Sponsor's protocol ID
- SwedishICR
- Status last verified
- Sep 2023
- First submitted
- 12 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients´ Mental and Physical Health After Being Treated for Covid-19 in an Intensive Care Unit in Sweden, a National Register Study
- ClinicalTrials.gov ID
- NCT06042790
- Acronym / sponsor ID
- SwedishICR
- Conditions
- Quality of Life, Intensive Care Unit Syndrome
- Keywords
- Covid 19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Swedish Intensive Care RegistryUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 8 Aug 2022 (actual)
- Study completion
- 8 Oct 2023 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Covid-19 is a disease where both clinical experience and thus knowledge about the long-term effects of the disease are currently sparse. However, current follow-up results indicate a more pronounced cognitive and respiratory impairment than previously seen in a normal ICU population. As we know that the prevalence of impairments in neurocognitive and Health Related Quality of Life (HRQoL) is increased in a majority of ICU patients, it would be of benefit to gain knowledge about the impact on the recovery trajectory for patients treated for Covid-19, and to increase the understanding of which factors that affect the HRQoL and recovery and in what way these differs between patients treated in ICU for Covid-19 and other causes respectively. This can contribute to better structures for follow-up and possibility to individualisation that better address which patients are in risk for decreased HRQoL and where benefit for the patient, health care and social economic 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Covid-19 ICU patients | – | –Patients with confirmed Covid-19 admitted to ICU care |
| non-Covid-19 patients | – | –Non Coivd-19 patients admitted to ICU before 2020 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Group I ICU patients with Covid-19 Group II ICU patients without Covid-19
Key inclusion criteria (1 listed)
- Consecutively admitted ICU patients with a completed RAND-36 follow-up form
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HRQoL
Time frame: 2, 6, 12 months post ICU
RAND-36
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sten Walther, PhD study chair
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Intensive Care Unit Syndrome, run by Swedish Intensive Care Registry at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HRQoL (time frame: 2, 6, 12 months post ICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.