NCT05111275

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
29mo left

Started Oct 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress66%
Oct 2021Sep 2028

Study Start

First participant enrolled

October 1, 2021

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 8, 2021

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2028

Last Updated

June 27, 2023

Status Verified

June 1, 2023

Enrollment Period

7 years

First QC Date

October 30, 2021

Last Update Submit

June 25, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Cognitive disorders

    Cognitive disorders assessed by the MoCA (Montreal Cognitive Assessment) test

    At one month after inclusion

  • Cognitive disorders

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

    At one month after inclusion

Other Outcomes (1)

  • Cognitive activities

    At one month after inclusion

Study Arms (2)

Group MEMO

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

Exercises that stimulate and train memory, attention, executive functions, language and gnosis.

Group MEMO

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Survivor of an ICU stay of at least 7 days
  • French speaker

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Liège

Liège, 4000, Belgium

Location

MeSH Terms

Conditions

Critical IllnessCognition Disorders

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Clinic

Study Record Dates

First Submitted

October 30, 2021

First Posted

November 8, 2021

Study Start

October 1, 2021

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

September 30, 2028

Last Updated

June 27, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations