An interventional study of Cognitive exercises in Critical Illness and Cognition Disorder, sponsored by University of Liege. Active, not recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-27.
Sponsored by University of Liege · Not applicable, Interventional, and Supportive care
This study concerns patients who survived intensive care, after a minimum stay of 7 days and presenting cognitive disorders (with a score ≤ 26 on the MoCA test) during the post-intensive care follow-up consultation one month after ICU discharge.
The objective of this prospective open-label randomized study is to assess the impact of cognitive stimulation on recovery from cognitive impairment after a critical illness.
Patients who survive a critical illness and a stay in intensive care may present a post-intensive care syndrome. This syndrome comprises in particular cognitive disorders, with memory disorders and executive disorders. The systemic inflammatory reaction seems to play an important role in the genesis of these disorders. Frequently reported risk factors are numerous and include hypoxemia, hypotension, glycemic dysregulation, drug toxicities, and, delirium.
In post-intensive care, these cognitive disorders are most often detected using screening tests that quickly and superficially assess the major components of cognition. During the standardized screening that we offer to patients who join the follow-up clinic of our university hospital, we use the MoCA (Montreal Cognitive Assessment) as a screening test. In a series of patients who survived a severe form of COVID-19, we observed that more than 80% of patients did not achieve the maximum score on this test (MoCA \<30/30) 3 months after ICU discharge, thus signifying the presence of cognitive impairment. Half of these patients had mild disorders (MoCA> 26/30), the other half had more pronounced disorders, based on commonly accepted cut-off values (MoCA ≤ 26/30). Similar data are reported in other populations: cognitive disorders are frequently encountered after ARDS of other etiologies [5, 6], and may persist for several years after the acute episode [7].
In Belgium, access to an exhaustive cognitive assessment and cognitive rehabilitation is subject to different access criteria, which are not necessarily met by patients who have survived intensive care. Such rehabilitation is then quite expensive for the patient. Patients with cognitive impairment after intensive care may nevertheless benefit from aids in cognitive recovery. In a few rare studies, it seems that non-specific cognitive training can improve the cognitive outcome of patients who have survived intensive care [8].
According to several neuropsychologists interviewed as part of a preliminary investigation, there are cognitive stimulation tools that could activate spontaneous cognitive recovery in post-intensive care. Among them, the MEMO website (http://www.memory-motivation.org/home-2/) offers free access to batteries of cognitive exercises. This website was created by a team of psychologists, doctors, engineers and researchers in connection with the University of Nice Sophia Antipolis. It was designed to meet the needs of patients with cognitive disorders, healthcare professionals involved in prevention, rehabilitation and cognitive stimulation. This computer hardware playfully stimulates memory, attention, executive functions, language and gnosias. Several levels of difficulty are foreseen. In addition, the prescriber, by creating a professional profile on the website, can monitor the compliance and performance of patients to whom he has advised this platform.
This tool is intended as a means of stimulating cognitive recovery, but does not replace neuropsychological management in the event of persistent cognitive disorders.
The aim of our prospective randomized study is to assess the impact of cognitive stimulation on the course of cognitive impairment within two months of discharge from intensive care. Cognitive exercise cannot be offered too soon after the critical episode because patients are extremely tired. On the contrary, these exercises cannot be postponed too long in order to optimize the recovery as quickly as possible to the best possible functional state.
1,923 studies on the registry are indexed under Critical Illness; 465 are open to participants now.
This study's planned enrollment of 130 is above the median of 90 across 1,003 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →University of Liege is the lead sponsor of 250 studies on the registry; 49 are open to participants now.
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Exclusion Criteria:
Patients will perform cognitive exercises on the MEMO site at least 4 times per week for a month. During this month, patients will be contacted by phone on a weekly basis in order to maintain their motivation and ensure their treatment compliance. The time spent on the site during the month of evaluation will be quantified by the study investigator, via the professional profile created on the MEMO site, allowing to see the patient's activity on this same site.
Other: Cognitive exercises
Patients will not change their habits or perform cognitive exercises during the same assessment period.
Exercises that stimulate and train memory, attention, executive functions, language and gnosis.
Cognitive disorders
Cognitive disorders assessed by the MoCA (Montreal Cognitive Assessment) test
Time frame: At one month after inclusion
Cognitive disorders
Cognitive disorders assessed by the RBANS (Repeatable Battery for the Assessment of Neuropsychological Status) test
Time frame: At one month after inclusion
Cognitive activities
Quantification of the time dedicated to cognitive tasks during ICU stay (i.e.: reading, playing, cooking)
Time frame: At one month after inclusion
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2021 (actual). Primary completion is estimated for Sep 2028, 83 months after the start.
Of 422 non-industry interventional studies with no phase under Critical Illness, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 38. This study's planned 83 months is above that.
Counting every sponsor, half of 427 studies reached it within 21 months; a quarter within 11 and three quarters within 37.
Critical Illness covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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This study is active, not recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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