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Cognitive Exercises in Survivors of a Prolonged ICU Stay.

Primary Purpose

Critical Illness, Cognition Disorder

Status
Active
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Cognitive exercises
Sponsored by
University of Liege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Critical Illness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Survivor of an ICU stay of at least 7 days
  • Score ≤ 26 at the MoCA test at inclusion
  • French speaker

Exclusion Criteria:

  • Blindness
  • Known mental disability
  • Known dementia
  • Cognitive rehabilitation in progress
  • No internet connection
  • Patient not knowing how to use the internet
  • Patient refusal

Sites / Locations

  • University Hospital of Liège

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group MEMO

Control Group

Arm Description

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.

Patients will not change their habits or perform cognitive exercises during the same assessment period.

Outcomes

Primary Outcome Measures

Cognitive disorders
Cognitive disorders assessed by the MoCA (Montreal Cognitive Assessment) test
Cognitive disorders
Cognitive disorders assessed by the RBANS (Repeatable Battery for the Assessment of Neuropsychological Status) test

Secondary Outcome Measures

Full Information

First Posted
October 30, 2021
Last Updated
June 25, 2023
Sponsor
University of Liege
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1. Study Identification

Unique Protocol Identification Number
NCT05111275
Brief Title
Cognitive Exercises in Survivors of a Prolonged ICU Stay.
Official Title
Impact of Cognitive Exercises on Cognitive Disorders in Survivors of a Prolonged ICU Stay.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
September 30, 2028 (Anticipated)
Study Completion Date
September 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Cognition Disorder

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group MEMO
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patients will not change their habits or perform cognitive exercises during the same assessment period.
Intervention Type
Other
Intervention Name(s)
Cognitive exercises
Intervention Description
Exercises that stimulate and train memory, attention, executive functions, language and gnosis.
Primary Outcome Measure Information:
Title
Cognitive disorders
Description
Cognitive disorders assessed by the MoCA (Montreal Cognitive Assessment) test
Time Frame
At one month after inclusion
Title
Cognitive disorders
Description
Cognitive disorders assessed by the RBANS (Repeatable Battery for the Assessment of Neuropsychological Status) test
Time Frame
At one month after inclusion
Other Pre-specified Outcome Measures:
Title
Cognitive activities
Description
Quantification of the time dedicated to cognitive tasks during ICU stay (i.e.: reading, playing, cooking)
Time Frame
At one month after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Survivor of an ICU stay of at least 7 days Score ≤ 26 at the MoCA test at inclusion French speaker Exclusion Criteria: Blindness Known mental disability Known dementia Cognitive rehabilitation in progress No internet connection Patient not knowing how to use the internet Patient refusal
Facility Information:
Facility Name
University Hospital of Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cognitive Exercises in Survivors of a Prolonged ICU Stay.

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