Prediction of the Post-intensive Care Syndrome

NCT05690438 | Completed

• 1 other identifier: Dnr KS K2022-4466
• Study Type: observational
• Target: 773
• Locations: 1 country
• Sites: 4

Brief 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. 1.Can the screening method at ICU discharge predict psychological symptoms three months after ICU stay?
2. 2.Can the screening method at ICU discharge predict new-onset physical disability three months after ICU stay?
3. 3.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.

Conditions

Critical Care

Keywords

Post-intensive care syndrome; Depression; Anxiety; Post-traumatic stress; Physical disability; Pain; Frailty; Resilience

Outcome Measures

Primary Outcomes (15)

• Predictive accuracy of a psychological screening method

  Validation of a previously developed screening method for psychological problems three months post-ICU

  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

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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

  Inclusion during one year, follow-up three months post-ICU discharge

• Health-related quality of life in patients with pain post-ICU

  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.

  Inclusion during one year, follow-up three months post-ICU discharge

• Health-related quality of life and associations with resilience

  Inclusion during one year, follow-up three months post-ICU discharge

• Validation of questionnaires in a Swedish ICU population and psychometric testing

  One year

Other Outcomes (1)

• Physical function at ICU discharge and mortality

  Three months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

General adult ICU population, all admitted patients will be consecutively screened for inclusion.

You may qualify if:

• Adult patients, ≥18 years old, with an ICU stay ≥12 hours, surviving to ICU discharge.

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Stockholm: lead
• Karolinska Institutet: collaborator

Study Sites (4)

Karolinska University Hospital

Stockholm, 113 45, Sweden

Location

Capio S:t Göran's Hospital

Stockholm, Sweden

Location

Danderyd's Hospital

Stockholm, Sweden

Location

Södersjukhuset

Stockholm, Sweden

Location

MeSH Terms

Conditions

postintensive care syndrome; Depression; Anxiety Disorders; Pain; Frailty

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Anna Milton

  Karolinska Institutet/Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: January 19, 2023
• Study Start: January 9, 2023
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

SE (4)