Critical CarePREPICSNCT05690438
Prediction of the Post-intensive Care Syndrome
An observational study of Critical Care, run by Region Stockholm at 4 sites in Sweden.
Trial summary
The goal of this observational study is to assess whether a screening of patients at discharge from the intensive care unit (ICU) can predict psychological and physical problems three months later. The main questions to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Care
- How many people
- 773 participants
- Where
- 4 sitesSweden
- Study dates
- 9 Jan 2023to 30 Apr 2025
- 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: General adult ICU population, all admitted patients will be consecutively screened for inclusion.
Who may be able to join
- Adult patients, ≥18 years old, with an ICU stay ≥12 hours, surviving to ICU discharge.
Who cannot join
- No home address
- Dementia or other major cognitive dysfunction
- Unsufficient knowledge of the Swedish language for answering follow-up questionnaires
- Two or more limitations of treatment or moribund patient
Trial locations and contacts
4 sites in 1 country.
Sweden4 sites
Karolinska University Hospital
Stockholm, 113 45
Capio S:t Göran's Hospital
Stockholm
Danderyd's Hospital
Stockholm
Södersjukhuset
Stockholm
About this study
The goal of this observational study is to assess whether a screening of patients at discharge from the intensive care unit (ICU) can predict psychological and physical problems three months later.
The main questions to answer are:
- Can the screening method at ICU discharge predict psychological symptoms three months after ICU stay?
- Can the screening method at ICU discharge predict new-onset physical disability three months after ICU stay?
- Does pain, resilience (the individuals\' ability to handle distress) and frailty affect the risk of developing psychological and physical problems three months after ICU stay? All adult patients with an ICU stay 12 hours or longer will be assessed for inclusion in the study. Three months after discharge from the ICU included patients will be asked to digitally answer a set of questionnaires, rating symptoms of depression, anxiety, post-traumatic stress and ability to perform activities of daily living. Patients will also be asked to state their health-related quality of life and on-going pain, how the pain affects their everyday life and the ability to endure difficult situations.
Read the detailed description
Firstly, the investigators hypothesize that two novel screening instruments, developed by the research group, for identification of intensive care unit (ICU) survivors with elevated risk for psychological and physical morbidity have high external validity. Secondly, the investigators hypothesize that frailty, pain and resilience will affect the probability of developing post-intensive care syndrome (PICS) three months post-ICU.
The specific objectives with the project are:
- To assess the predictive value and hence the validity of a screening instrument assessing the risk for
- psychological problems (study I)
- new-onset physical disability (study II) three months post-ICU
- To evaluate if pain, frailty and resilience, i.e the individual's ability to handle distress, affect the development of PICS three months post-ICU (study III)
- To assess individual daily wellbeing with a digital diary (study IV)
Studies I-III are observational cohort studies including 800 adult patients admitted to the ICU for a minimum of 12 hours. Consecutively discharged ICU patients will be assessed with the PROGRESS-ICU screening instruments, generating an individual risk in percentage for a) psychological problems and b) new-onset physical disability three months post-ICU. The instruments consists of questions regarding depressive symptoms, traumatic memories from the ICU stay, social support and age and an evaluation of the patient´s physical status at ICU discharge, assessed with the first five items of the Chelsea Critical Care Physical Assessment Tool, CPAx. Patients will also be asked to state their level of pain at discharge with a numeric rating scale (NRS). Basic demographics will be collected from the patient data management system, such as sex, admission diagnosis, severity of illness, ICU length of stay and duration of mechanical ventilation. Patients or next of kin will also be asked to state the patients' level of independence in performing ten different ADLs two weeks prior to hospitalisation, assessed with the Barthel Index (BI). Frailty will be assessed with the Clinical Frailty Scale (CFS).
Three months after ICU discharge, patients will be asked to digitally, or on paper by regular mail, fill out validated questionnaires assessing level of symptoms of depression, anxiety (Hospital Anxiety and Depression Scale (HADS)) and post-traumatic stress (Post-Traumatic Stress Symptom 14-question inventory (PTSS-14)). New-onset physical disability will be assessed with the Barthel index (BI), a questionnaire assessing the level of independency in performing activities of daily living. In accordance with the cut-offs recommended in the literature, and level used for caseness in the studies developing the screening instruments, a HADS subscale score ≥11 and a PTSS-14 part B score \>45 will define clinically substantial psychological symptoms 24,25. A BI score reduction of ≥10 compared to baseline will define substantial new-onset physical disability and is close to the minimum clinically important difference suggested for the BI. At the three months follow-up patients will also be assessed regarding pain with the NRS and resilience with the modified version of the validated questionnaire Psychological Inflexibility in Pain Scale (PIPS), addressing the tendency to avoid situations that could imply pain or other discomforts. Self-efficay will also be assessed, i.e. the belief in one's ability to handle distress as a measure of resilience with the General self-efficacy scale. Health-related quality of life will be assessed with the RAND-36. The investigators also plan to perform psychometric testing of the questionnaires used and validate them in Swedish for the relevant population.
In a subgroup of patients (n=15) daily wellbeing will be evaluated with a digital diary where patients will be asked to answer short questions regarding their present mood twice a day for a total of 30 days (14 days in a row, with a pause for 4 weeks and a new 14-day period of digital diary questions). The questions will be available to patients via an application in a smartphone/tablet, reminding them to answer the questions twice a day through a message/push notification. This will render multiple data points for each individual enabling analyses of the development over time as well as individual variations. Fifteen participants are deemed sufficient for a first analysis of aggregated individual data. This type of data is also an important step towards the next phase, to develop tailored interventions matching the specific needs of the individual ICU survivor.
- Conditions
- Critical Care
- Keywords
- Post-intensive care syndrome, Depression, Anxiety, Post-traumatic stress, Physical disability, Pain, Frailty, Resilience
- Medical subject headings
- postintensive care syndrome, Depression, Anxiety Disorders, Pain, Frailty
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive accuracy of a psychological screening method
Validation of a previously developed screening method for psychological problems three months post-ICU
Measured: Outcome measured three months after ICU discharge
Predictive accuracy of a physical screening method
Validation of a previously developed screening method for physical problems three months post-ICU
Measured: Outcome measured three months after ICU discharge
Frailty (assessed with the clinical frailty scale) and psychological outcome after ICU stay, assessed with the Hospital Anxiety and Depression Scale.
Assessment of associations between frailty (assessed with the clinical frailty scale) and the development of symptoms of depression and anxiety post-ICU.
Measured: Outcome measured three months after ICU discharge
Frailty (assessed with the clinical frailty scale) and psychological outcome after ICU stay, assessed with the Post-Traumatic Stress 14-Question Inventory.
Assessment of associations between frailty (assessed with the clinical frailty scale) and the development of the post-traumatic stress symptoms.
Measured: Outcome measured three months after ICU discharge
Frailty (assessed with the clinical frailty scale) and physical outcome after ICU stay, assessed with the Barthel Index.
Assessment of associations between frailty (assessed with the clinical frailty scale) and the development of the post-intensive care syndrome physical problems.
Measured: Outcome measured three months after ICU discharge
Pain (assessed with the numeric rating scale, NRS) and physical outcome after ICU stay, assessed with the Barthel Index.
Assessment of associations between pain and the development of the post-intensive care syndrome physical aspects.
Measured: Outcome measured three months after ICU discharge
Pain (assessed with the numeric rating scale, NRS) and psychological outcome after ICU stay, assessed with the Post-Traumatic Stress 14-Question Inventory.
Assessment of associations between pain and the development of symptoms of post-traumatic stress post-ICU.
Measured: Outcome measured three months after ICU discharge
Pain (assessed with the numeric rating scale, NRS) and psychological outcome after ICU stay, assessed with the Hospital Anxiety and Depression Scale.
Assessment of associations between pain and the development of symptoms of depression and anxiety post-ICU.
Measured: Outcome measured three months after ICU discharge
Resilience (assessed with the general self-efficacy scale, the pain catastrophizing scale and the psychological inflexibility in pain scale) and physical outcome after ICU stay (assessed with the Barthel Index).
Assessment of associations between resilience and the development of the post-intensive care syndrome physical problems.
Measured: Outcome measured three months after ICU discharge
Resilience (assessed with the general self-efficacy scale, the pain catastrophizing scale and the psychological inflexibility in pain scale) and psychological outcome after ICU stay, assessed with the Hospital Anxiety and Depression Scale.
Assessment of associations between resilience and the development of symptoms of depression and anxiety post-ICU.
Measured: Outcome measured three months after ICU discharge
Resilience (assessed with the general self-efficacy scale, the pain catastrophizing scale and the psychological inflexibility in pain scale) and psychological outcome after ICU stay
Assessment of associations between resilience and the development of symptoms of post-traumatic stress post-ICU.
Measured: Outcome measured three months after ICU discharge
Feasibility of a daily digital diary in ICU survivors
Feasibility of a digital diary post-ICU assessed with a patient questionnaire at the end of the diary period and number of and reason for drop out.
Measured: Diary questions during 14 + 14 days after ICU discharge, questionnaire at termination of the diary.
Daily variations of well-being in ICU survivors
Digital diary with questions related to well-being for individual ICU survivors for a total of 30 days (14 + 14 days with a 4-week pause in between) post-ICU discharge.
Measured: Digital diary questions during 14 + 14 days after ICU discharge, with follow-up questionnaires three months post-ICU
With-in person associations between cognitive-affective state and daily well-being in ICU survivors
Daily diary questions on mood and cognitive state and associations with daily well-being questions (sleep, tiredness, stress) post-ICU discharge.
Measured: Digital diary questions during 14 + 14 days after ICU discharge, with follow-up questionnaires three months post-ICU
Associations between high daily patterns of cognitive-affective state between individuals and psychological recovery
Daily diary questions on mood and cognitive state and associations with symptoms of depression, anxiety and post-traumatic stress post-ICU discharge.
Measured: Digital diary questions during 14 + 14 days after ICU discharge, with follow-up questionnaires three months post-ICU
Secondary outcomes (12)
Health-related quality of life in patients with psychological and/or physical problems post-ICU
Health-related quality of life assessed with the RAND-36
Measured: Inclusion during one year, follow-up three months post-ICU discharge
Health-related quality of life in patients with pain post-ICU
HRQL assessed with the RAND-36
Measured: Inclusion during one year, follow-up three months post-ICU discharge
Health-related quality of life and associations with pre-ICU frailty assessed with the Clinical Frailty Scale.
HRQL assessed with the RAND-36, frailty with the clinical frailty scale.
Measured: Inclusion during one year, follow-up three months post-ICU discharge
Health-related quality of life and associations with resilience
HRQL assessed with the RAND-36
Measured: Inclusion during one year, follow-up three months post-ICU discharge
Validation of questionnaires in a Swedish ICU population and psychometric testing
Used questionnaires will be validated in a Swedish ICU population and psychometric testing will be performed.
Measured: One year
Clinical frailty, assessed with the Clinical Frailty Scale, and ICU length-of-stay
Clinical frailty and associations with ICU length-of-stay
Measured: Outcome measured at discharge from the ICU
Clinical frailty, assessed with the Clinical Frailty Scale, and duration of mechanical ventilation in ICU
Clinical frailty and associations with duration of mechanical ventilation in ICU
Measured: Outcome measured at discharge from the ICU
Clinical frailty, assessed with the Clinical Frailty Scale, and symptoms of psychological problems post-ICU assessed with the Hospital Anxiety and Depression Scale.
Clinical frailty and associations with symptoms of depression and anxiety three months post-ICU
Measured: Outcome measured three months after discharge from the ICU
Clinical frailty, assessed with the Clinical Frailty Scale, and symptoms of post-traumatic stress post-ICU assessed with the Post-Traumatic Stress Symptom 14-Question Inventory.
Clinical frailty and associations with symptoms of post-traumatic stress three months post-ICU
Measured: Outcome measured three months after discharge from the ICU
Clinical frailty, assessed with the Clinical Frailty Scale, and physical performance at ICU discharge assessed with the Chelsea Critical care physical assessment tool
Clinical frailty and associations with physical status at ICU discharge
Measured: Outcome measured at discharge from the ICU
Clinical frailty, assessed with the Clinical Frailty Scale, and ICU mortality.
Clinical frailty and associations with ICU mortality
Measured: Outcome measured at discharge from the ICU
Clinical frailty, assessed with the Clinical Frailty Scale, and three-month physical function assessed with the Barthel Index.
Clinical frailty and associations with post-ICU physical functioning.
Measured: Outcome measured three months after discharge from the ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start9 Jan 2023
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical CareStudies of the same condition, open and under way.
- More trials run by Region StockholmThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 773 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Anna Milton, Region Stockholm
- Investigators
- Anna Milton, Principal investigator, Karolinska Institutet/Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690438
- Sponsor's protocol ID
- Dnr KS K2022-4466
- Acronym
- PREPICS
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2022
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of the Post-intensive Care Syndrome
- ClinicalTrials.gov ID
- NCT05690438
- Acronym / sponsor ID
- PREPICS / Dnr KS K2022-4466
- Conditions
- Critical Care
- Keywords
- Post-intensive care syndrome, Depression, Anxiety, Post-traumatic stress, Physical disability, Pain, Frailty, Resilience
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 773 participants (actual)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Karolinska Institutet
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 19 Jan 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.
The goal of this observational study is to assess whether a screening of patients at discharge from the intensive care unit (ICU) can predict psychological and physical problems three months later.
The main questions to answer are:
- Can the screening method at ICU discharge predict psychological symptoms three months after ICU stay?
- Can the screening method at ICU discharge predict new-onset physical disability three months after ICU stay?
- Does pain, resilience (the individuals\' ability to handle distress) and frailty affect the risk of developing psychological and physical problems three months after ICU stay? All adult patients with an ICU stay 12 hours or longer will be assessed for inclusion in the study. Three months after discharge from the ICU included patients will be asked to digitally answer a set of questionnaires, rating symptoms of depression, anxiety, post-traumatic stress and ability to perform activities of daily living. Patients will also be asked to state their health-related quality of life and on-going pain, how the pain affects their everyday life and the ability to endure difficult situations.
Detailed description
Firstly, the investigators hypothesize that two novel screening instruments, developed by the research group, for identification of intensive care unit (ICU) survivors with elevated risk for psychological and physical morbidity have high external validity. Secondly, the investigators hypothesize that frailty, pain and resilience will affect the probability of developing post-intensive care syndrome (PICS) three months post-ICU.
The specific objectives with the project are:
- To assess the predictive value and hence the validity of a screening instrument assessing the risk for
- psychological problems (study I)
- new-onset physical disability (study II) three months post-ICU
- To evaluate if pain, frailty and resilience, i.e the individual's ability to handle distress, affect the development of PICS three months post-ICU (study III)
- To assess individual daily wellbeing with a digital diary (study IV)
Studies I-III are observational cohort studies including 800 adult patients admitted to the ICU for a minimum of 12 hours. Consecutively discharged ICU patients will be assessed with the PROGRESS-ICU screening instruments, generating an individual risk in percentage for a) psychological problems and b) new-onset physical disability three months post-ICU. The instruments consists of questions regarding depressive symptoms, traumatic memories from the ICU stay, social support and age and an evaluation of the patient´s physical status at ICU discharge, assessed with the first five items of the Chelsea Critical Care Physical Assessment Tool, CPAx. Patients will also be asked to state their level of pain at discharge with a numeric rating scale (NRS). Basic demographics will be collected from the patient data management system, such as sex, admission diagnosis, severity of illness, ICU length of stay and duration of mechanical ventilation. Patients or next of kin will also be asked to state the patients' level of independence in performing ten different ADLs two weeks prior to hospitalisation, assessed with the Barthel Index (BI). Frailty will be assessed with the Clinical Frailty Scale (CFS).
Three months after ICU discharge, patients will be asked to digitally, or on paper by regular mail, fill out validated questionnaires assessing level of symptoms of depression, anxiety (Hospital Anxiety and Depression Scale (HADS)) and post-traumatic stress (Post-Traumatic Stress Symptom 14-question inventory (PTSS-14)). New-onset physical disability will be assessed with the Barthel index (BI), a questionnaire assessing the level of independency in performing activities of daily living. In accordance with the cut-offs recommended in the literature, and level used for caseness in the studies developing the screening instruments, a HADS subscale score ≥11 and a PTSS-14 part B score \>45 will define clinically substantial psychological symptoms 24,25. A BI score reduction of ≥10 compared to baseline will define substantial new-onset physical disability and is close to the minimum clinically important difference suggested for the BI. At the three months follow-up patients will also be assessed regarding pain with the NRS and resilience with the modified version of the validated questionnaire Psychological Inflexibility in Pain Scale (PIPS), addressing the tendency to avoid situations that could imply pain or other discomforts. Self-efficay will also be assessed, i.e. the belief in one's ability to handle distress as a measure of resilience with the General self-efficacy scale. Health-related quality of life will be assessed with the RAND-36. The investigators also plan to perform psychometric testing of the questionnaires used and validate them in Swedish for the relevant population.
In a subgroup of patients (n=15) daily wellbeing will be evaluated with a digital diary where patients will be asked to answer short questions regarding their present mood twice a day for a total of 30 days (14 days in a row, with a pause for 4 weeks and a new 14-day period of digital diary questions). The questions will be available to patients via an application in a smartphone/tablet, reminding them to answer the questions twice a day through a message/push notification. This will render multiple data points for each individual enabling analyses of the development over time as well as individual variations. Fifteen participants are deemed sufficient for a first analysis of aggregated individual data. This type of data is also an important step towards the next phase, to develop tailored interventions matching the specific needs of the individual ICU survivor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- General adult ICU population, all admitted patients will be consecutively screened for inclusion.
Key inclusion criteria (1 listed)
- Adult patients, ≥18 years old, with an ICU stay ≥12 hours, surviving to ICU discharge.
Key exclusion criteria (4 listed)
- No home address
- Dementia or other major cognitive dysfunction
- Unsufficient knowledge of the Swedish language for answering follow-up questionnaires
- Two or more limitations of treatment or moribund patient
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
Predictive accuracy of a psychological screening method
Time frame: Outcome measured three months after ICU discharge
Validation of a previously developed screening method for psychological problems three months post-ICU
Predictive accuracy of a physical screening method
Time frame: Outcome measured three months after ICU discharge
Validation of a previously developed screening method for physical problems three months post-ICU
Frailty (assessed with the clinical frailty scale) and psychological outcome after ICU stay, assessed with the Hospital Anxiety and Depression Scale.
Time frame: Outcome measured three months after ICU discharge
Assessment of associations between frailty (assessed with the clinical frailty scale) and the development of symptoms of depression and anxiety post-ICU.
Frailty (assessed with the clinical frailty scale) and psychological outcome after ICU stay, assessed with the Post-Traumatic Stress 14-Question Inventory.
Time frame: Outcome measured three months after ICU discharge
Assessment of associations between frailty (assessed with the clinical frailty scale) and the development of the post-traumatic stress symptoms.
Frailty (assessed with the clinical frailty scale) and physical outcome after ICU stay, assessed with the Barthel Index.
Time frame: Outcome measured three months after ICU discharge
Assessment of associations between frailty (assessed with the clinical frailty scale) and the development of the post-intensive care syndrome physical problems.
Pain (assessed with the numeric rating scale, NRS) and physical outcome after ICU stay, assessed with the Barthel Index.
Time frame: Outcome measured three months after ICU discharge
Assessment of associations between pain and the development of the post-intensive care syndrome physical aspects.
Pain (assessed with the numeric rating scale, NRS) and psychological outcome after ICU stay, assessed with the Post-Traumatic Stress 14-Question Inventory.
Time frame: Outcome measured three months after ICU discharge
Assessment of associations between pain and the development of symptoms of post-traumatic stress post-ICU.
Pain (assessed with the numeric rating scale, NRS) and psychological outcome after ICU stay, assessed with the Hospital Anxiety and Depression Scale.
Time frame: Outcome measured three months after ICU discharge
Assessment of associations between pain and the development of symptoms of depression and anxiety post-ICU.
Resilience (assessed with the general self-efficacy scale, the pain catastrophizing scale and the psychological inflexibility in pain scale) and physical outcome after ICU stay (assessed with the Barthel Index).
Time frame: Outcome measured three months after ICU discharge
Assessment of associations between resilience and the development of the post-intensive care syndrome physical problems.
Resilience (assessed with the general self-efficacy scale, the pain catastrophizing scale and the psychological inflexibility in pain scale) and psychological outcome after ICU stay, assessed with the Hospital Anxiety and Depression Scale.
Time frame: Outcome measured three months after ICU discharge
Assessment of associations between resilience and the development of symptoms of depression and anxiety post-ICU.
Resilience (assessed with the general self-efficacy scale, the pain catastrophizing scale and the psychological inflexibility in pain scale) and psychological outcome after ICU stay
Time frame: Outcome measured three months after ICU discharge
Assessment of associations between resilience and the development of symptoms of post-traumatic stress post-ICU.
Feasibility of a daily digital diary in ICU survivors
Time frame: Diary questions during 14 + 14 days after ICU discharge, questionnaire at termination of the diary.
Feasibility of a digital diary post-ICU assessed with a patient questionnaire at the end of the diary period and number of and reason for drop out.
Daily variations of well-being in ICU survivors
Time frame: Digital diary questions during 14 + 14 days after ICU discharge, with follow-up questionnaires three months post-ICU
Digital diary with questions related to well-being for individual ICU survivors for a total of 30 days (14 + 14 days with a 4-week pause in between) post-ICU discharge.
With-in person associations between cognitive-affective state and daily well-being in ICU survivors
Time frame: Digital diary questions during 14 + 14 days after ICU discharge, with follow-up questionnaires three months post-ICU
Daily diary questions on mood and cognitive state and associations with daily well-being questions (sleep, tiredness, stress) post-ICU discharge.
Associations between high daily patterns of cognitive-affective state between individuals and psychological recovery
Time frame: Digital diary questions during 14 + 14 days after ICU discharge, with follow-up questionnaires three months post-ICU
Daily diary questions on mood and cognitive state and associations with symptoms of depression, anxiety and post-traumatic stress post-ICU discharge.
12 secondary outcomes
Health-related quality of life in patients with psychological and/or physical problems post-ICU
Time frame: Inclusion during one year, follow-up three months post-ICU discharge
Health-related quality of life in patients with pain post-ICU
Time frame: Inclusion during one year, follow-up three months post-ICU discharge
Health-related quality of life and associations with pre-ICU frailty assessed with the Clinical Frailty Scale.
Time frame: Inclusion during one year, follow-up three months post-ICU discharge
Health-related quality of life and associations with resilience
Time frame: Inclusion during one year, follow-up three months post-ICU discharge
Validation of questionnaires in a Swedish ICU population and psychometric testing
Time frame: One year
Clinical frailty, assessed with the Clinical Frailty Scale, and ICU length-of-stay
Time frame: Outcome measured at discharge from the ICU
Clinical frailty, assessed with the Clinical Frailty Scale, and duration of mechanical ventilation in ICU
Time frame: Outcome measured at discharge from the ICU
Clinical frailty, assessed with the Clinical Frailty Scale, and symptoms of psychological problems post-ICU assessed with the Hospital Anxiety and Depression Scale.
Time frame: Outcome measured three months after discharge from the ICU
Clinical frailty, assessed with the Clinical Frailty Scale, and symptoms of post-traumatic stress post-ICU assessed with the Post-Traumatic Stress Symptom 14-Question Inventory.
Time frame: Outcome measured three months after discharge from the ICU
Clinical frailty, assessed with the Clinical Frailty Scale, and physical performance at ICU discharge assessed with the Chelsea Critical care physical assessment tool
Time frame: Outcome measured at discharge from the ICU
Clinical frailty, assessed with the Clinical Frailty Scale, and ICU mortality.
Time frame: Outcome measured at discharge from the ICU
Clinical frailty, assessed with the Clinical Frailty Scale, and three-month physical function assessed with the Barthel Index.
Time frame: Outcome measured three months after discharge from the ICU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
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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.
Anna Milton principal investigator
Karolinska Institutet/Karolinska University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Care, run by Region Stockholm at 4 sites 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 4 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: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Predictive accuracy of a psychological screening method (time frame: Outcome measured three months after ICU discharge). The study lists 15 primary outcomes in all. 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 23 Dec 2025.