CompletedNot Applicable

Prediction of the Post-intensive Care Syndrome

Sweden773 participantsStarted 2023-01-09

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patients, ≥18 years old, with an ICU stay ≥12 hours, surviving to ICU discharge. Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Predictive accuracy of a psychological screening method

Timeframe: Outcome measured three months after ICU discharge

Predictive accuracy of a physical screening method

Timeframe: 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.

Timeframe: 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.

Timeframe: 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.

Timeframe: 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.

Timeframe: Outcome measured three months after ICU discharge

Trial details

NCT IDNCT05690438

SponsorRegion Stockholm

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2025-04-30

View on ClinicalTrials.gov More Critical Care trials