ICU Follow-up After Prolonged Intensive Care Stay (NCT04186468) | Clinical Trial Compass
CompletedNot Applicable
ICU Follow-up After Prolonged Intensive Care Stay
Germany40 participantsStarted 2020-06-11
Plain-language summary
Treatment in the intensive care unit (ICU) for more than five days often leads to chronic physical, cognitive and psychological complaints, such as post-traumatic stress disorders, muscle weakness, depression, anxiety and adjustment disorders. This is referred to as Post Intensive Care Syndrome (PICS). So far, there have been only a few studies investigating this syndrome.
The aim of this pilot study is to test the effectiveness and feasibility of an ICU follow-up clinic, which our study team developed in a participatory process involving patients, caregivers, health care providers and researcher.
For this purpose, the participants will be randomly assigned to a group with treatment in this follow-up clinic or to a group with usual care. Both groups will then be compared.
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:
* duration of ICU stay more than five days
* sequential organ failure assessment score (SOFA) greater than five
* expected survival time greater than six months
* written informed consent
Exclusion Criteria:
* minor participants under the age of eighteen
* no written informed consent (unable or unwilling)
* unable to complete questionnaires
* insufficient German language skills
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.
1This trial studied people recovering from a prolonged ICU stay and looked at something called Post Intensive Care Syndrome — is that something I or my loved one might be at risk for, and what does that mean for life after leaving the ICU?
2The trial measured 'health-related quality of life, physical component summary' as its main outcome — what kinds of physical challenges does this typically track, and how does that compare to what I should realistically expect during recovery?
3Since this trial is now completed, have the results been published or shared anywhere, and can you walk me through what the findings might mean for how my follow-up care is structured?
4This study focused specifically on ICU follow-up programs — does our hospital or care team offer any structured follow-up support after a prolonged ICU stay, and if not, what resources are available to help with recovery?
5Given that this was listed as 'Phase NA,' meaning it was likely an observational or quality-of-life study rather than a drug trial, how does the evidence from this kind of research influence the follow-up care plan you would recommend for someone in my situation?
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
1
Health related quality of life, physical component summary score (HRQOL-PCS)