Computerized Training of Attention and Working Memory in Post COVID-19 Patients With Cognitive Complaints

NCT05831839 | Enrolling By Invitation DMC

• 1 other identifier: NL84105.078.23
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Many post COVID-19 patients suffer from cognitive deficits, even after 1 year after hospitalization. These complaints have a huge impact on psychological well-being and quality of life. In rehabilitation programs in the Netherlands, most interventions are based on physical therapy or learning how to cope with fatigue and low levels of energy. In former studies computerized training of cognition in other populations has been proven to be effective. Knowledge on the effect of computerized training on attention and working memory in patients suffering from COVID-19 is urgently needed, and may contribute to more evidence-based rehabilitation programs for these patients. Therefore the effectiveness of computerized training of attention and working memory in post COVID-19 patients with cognitive complaints will be studied in this study.

Conditions

COVID-19; Cognitive Impairment; Cognition Disorder; Memory Disorders; Attention Deficit; Memory Impairment; Memory Loss; Attention Impaired

Keywords

COVID-19; cognitive failure; attention; memory; cognitive training; computerized training

Outcome Measures

Primary Outcomes (3)

• General cognition

  The Montreal Cognitive Assessment (MoCA) will be used for general cognitive screening for all patients at baseline measurement and after the intervention. The MoCA is designed as a rapid screening instrument for cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visioconstructional skills, conceptual thinking, calculations, and orientation. The possible score is 30 points; a score of ≥ 26 is considered as normal, 18-25 indicates mild cognitive impairment, 10-17 moderate cognitive impairment and \< 10 severe cognitive impairment.

  3 months

• Attention

  Change in visual selective attention, processing speed and concentration is measured in all patients with the D2 test at baseline measurement, after the intervention and at 3 months follow-up. Change in visual attention, executive function (divided attention) and processing speed is measured with the Trail Making Test (TMT A \& B) at baseline measurement, after the intervention and at 3 months follow up. The Stroop Test measures mental speed, executive attention and response inhibition in all participants of the study at baseline measurement, after the intervention and at 3 months follow-up.

  6-9 months

• Working memory

  Working memory is measured in all patients at baseline measurement, after the intervention and at 3 months follow-up with the use of the Digit Span Forward (DSF) and Digit Span Backward (DSB) test (part of the Wechsler adult intelligence scale). It involves the oral presentation of spans of digits. The measure has both a 7-item digits forward task and a 7-item digits backward task, each one with its own individual score. Together with 'calculation' (also a part of the Wechsler adult intelligence scale), an index for working memory can be calculated.

  6-9 months

Secondary Outcomes (6)

• Subjective cognitive complaints

  6-9 months

• Anxiety and depression

  6-9 months

• Health-related quality of life (HR-QoL)

  6-9 months

• Fatigue

  6-9 months

• Coping

  1 month

Study Arms (2)

Cognitive training 1

OTHER

Randomized wait-list controlled pilot trial

Device: RehaCom

Cognitive training 2

OTHER

Randomized wait-list controlled pilot trial

Device: RehaCom

Interventions

RehaCom DEVICE

computerized cognitive training

Cognitive training 1; Cognitive training 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18 years and older;
• patient has sufficient knowledge of Dutch language;
• CFQ\> 43 at 2 year follow-up of CO-FLOW, indicating persistent cognitive complaints;
• Computer and internet-access.

You may not qualify if:

• A potential participant who meets any of the following criteria will be excluded from participation in this study:
• Incapacitated patients like patients diagnosed with dementia;
• Patients should not be involved in concurrent rehabilitation program, cognitive behavioural therapy or psychotherapy targeting cognition, anxiety and/or depression.

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Rijndam Rehabilitation

Rotterdam, South Holland, 3015LJ, Netherlands

Location

MeSH Terms

Conditions

COVID-19; Cognitive Dysfunction; Cognition Disorders; Memory Disorders; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders

Study Officials

• Gerard Ribbers, Professor

  Professor Rehabilitation Medicine and chair of the department

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: GZ-Psychologist in training for Clinical Neuropsychologist

Model Details: Participants of the multicentre prospective cohort study CO-FLOW (NL NL74252.078.20) suffering from persistent cognitive complaints as measured with the Cognitive Failure Questionnaire (CFQ ) of the CO-FLOW-study, a multicentre prospective cohort study, will be invited (if they have agreed to be approached for further reaerch)

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: April 26, 2023
• Study Start: December 1, 2023
• Primary Completion: September 1, 2024
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)