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

Primary Purpose

COVID-19, Cognitive Impairment, Cognition Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
RehaCom
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, cognitive failure, attention, memory, cognitive training, computerized training

Eligibility Criteria

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

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Cognitive training 1

    Cognitive training 2

    Arm Description

    Randomized wait-list controlled pilot trial

    Randomized wait-list controlled pilot trial

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.

    Secondary Outcome Measures

    Subjective cognitive complaints
    The Cognitive Failures Test (CFQ) is used for all participants at baseline measurement, after the intervention and at 3 months follow-up to assess the frequency with which people experience cognitive failures in everyday life, such as absent-mindedness, slips and errors of perception, memory, and motor functioning. The total score of the scale is the sum of the ratings of the 25 individual items, yielding a score from 0-100. The CFQ has 3 sub-scales: forgetfulness, distractibility, and false triggering.
    Anxiety and depression
    The Dutch Hospital Anxiety and Depression Scale (HADS) is used for all participants at baseline measurement, after the intervention and at 3 months follow-up as a general measure of emotional distress and contains two sub-scales: anxiety and depression. Each sub-scale consists of 7 items, which are rated on a 0 to 3 point rating scale. Sub-scale scores ≥ 8 might indicate the presence of a depressive disorder or an anxiety disorder. Reliability and validity are adequate for several clinical populations, including multiple sclerosis and acquired brain injury.
    Health-related quality of life (HR-QoL)
    The EQ-5D-5L is used for all participants at baseline measurement, after the intervention and at 3 months follow-up as a measurement for HR-QoL. The EQ-5D-5L consists of the 5-item EQ-5D index (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and a visual analogue scale (EQ VAS). Psychometric properties of the Dutch version showed to be good. The five EQ-5D index items are summarized into one weighted overall score, which runs from 0 for the value of death to 1.00 for full health. The EQ VAS ranges from 0 to 100 (worst to best imaginable health state). For the general Dutch population average EQ-5D index = 0.843 and average EQ VAS = 81.36.
    Fatigue
    The Fatigue Assessment Scale (FAS) is used for all participants at baseline measurement, after the intervention and at 3 months follow-up as a measurement for fatigue. The FAS is a simple and short self-administered questionnaire to assess chronic fatigue. Patients' agreement with 10 statements is rated on a 5 points Likert-scale, ranging from 1 ("never") to 5 ("always"). Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest.
    Coping
    The Coping Inventory for Stressful Situations (CISS-Short Form) is used at baseline measurement to measure coping styles of all participants. The short version of the CISS is used as a measure of coping with stressful situations. It has 21 items which are rated on a 1 to 5 point rating scale. It contains 3 subscales: task-oriented, emotion-oriented, and avoidance-oriented coping.
    Personality traits neuroticism and extraversion
    The Eysenck Personality Questionnaire Brief Version (EPQ-BV) is used at baseline measurement to measure level of neuroticism and level of extraversion of all participants. The EPQ-BV is a revised version of the EPQ-S to measure individuals on two primary personality traits in Eysenck's personality theory (1990). It consists of two measures, one for extraversion (12 items) and one for neuroticism (12 items).

    Full Information

    First Posted
    April 20, 2023
    Last Updated
    April 25, 2023
    Sponsor
    Erasmus Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05831839
    Brief Title
    Computerized Training of Attention and Working Memory in Post COVID-19 Patients With Cognitive Complaints
    Acronym
    CO-TRAINER
    Official Title
    Effectiveness of Computerized Training of Attention and Working Memory in Post COVID-19 Patients With Cognitive Complaints
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    September 1, 2024 (Anticipated)
    Study Completion Date
    September 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Erasmus Medical Center

    4. Oversight

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

    5. Study Description

    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.
    Detailed Description
    Since 2019, the world has been overwhelmed by COVID-19, a respiratory infectious disease. Current evidence suggests that approximately 10%-20% of people experience symptoms of post COVID-19 condition. Many post COVID-19 victims suffer from fatigue, cognitive deficits and / or subjective cognitive complaints, even after 1 year after hospitalization. Detailed research shows deficits in attention, both in sustained and executive components. Furthermore, less capacity of working memory, inhibition deficits and lower information processing speed is frequently reported. Fatigue and cognitive impairment have been consistently reported to be some of the most common and debilitating features of post COVID-19 condition. Like fatigue, cognitive complaints are associated with anxiety and depression and have an impact on every day functioning, return to work and account for diminished health-related quality of life (HR-QoL). There are no established and effective treatments yet for these patients. In former studies computerized training 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. Objective: The primary aim of this study is to evaluate the effect of a computerized cognitive rehabilitation program (RehaCom) in post COVID-19 patients with cognitive complaints. The secondary aim is to evaluate the effect of this computerized cognitive rehabilitation program on subjective cognitive complaints, psychological outcome measures and HR-QoL and to assess the feasibility of the program. Study design: Randomized wait-list controlled pilot trial. Study population: Participants of the multicentre prospective cohort study CO-FLOW (NL74252.078.20) suffering from persistent cognitive complaints after 2 years after hospitalization as measured with the Cognitive Failure Questionnaire (CFQ ) will be invited. Intervention: Computerized cognitive training, 10 weeks, 3 times/week 15 - 30 minutes/session. Main study parameters/endpoints: Cognitive functioning (attention and working memory) and psychological functioning (coping, anxiety, depression) and HR-QoL, using non-invasive neuropsychological tests and standardized online questionnaires. All outcomes will be assessed pre- and post-intervention and at 3 and 6 months follow-up. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The intervention is an online cognitive rehabilitation program, 3 times a week 15 - 30 minutes per session during 10 weeks. Participants can choose what time of the day is most convenient for them to engage in the program in their home environment. They might improve their attention and working memory, and therefore may also improve quality of life. Personal and disease characteristics are copied from patient records collected in the CO-FLOW study and additional measurements are non-invasive and minimally physically demanding. Completion of online questionnaires, additional neuropsychological measurements and joining the intervention require a certain time investment from patients and might lead to temporary fatigue. By a maximum duration of 30 minutes per session for online questionnaires and neuropsychological tests we aim to minimize the burden for patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Model Description
    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)
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cognitive training 1
    Arm Type
    Other
    Arm Description
    Randomized wait-list controlled pilot trial
    Arm Title
    Cognitive training 2
    Arm Type
    Other
    Arm Description
    Randomized wait-list controlled pilot trial
    Intervention Type
    Device
    Intervention Name(s)
    RehaCom
    Intervention Description
    computerized cognitive training
    Primary Outcome Measure Information:
    Title
    General cognition
    Description
    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.
    Time Frame
    3 months
    Title
    Attention
    Description
    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.
    Time Frame
    6-9 months
    Title
    Working memory
    Description
    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.
    Time Frame
    6-9 months
    Secondary Outcome Measure Information:
    Title
    Subjective cognitive complaints
    Description
    The Cognitive Failures Test (CFQ) is used for all participants at baseline measurement, after the intervention and at 3 months follow-up to assess the frequency with which people experience cognitive failures in everyday life, such as absent-mindedness, slips and errors of perception, memory, and motor functioning. The total score of the scale is the sum of the ratings of the 25 individual items, yielding a score from 0-100. The CFQ has 3 sub-scales: forgetfulness, distractibility, and false triggering.
    Time Frame
    6-9 months
    Title
    Anxiety and depression
    Description
    The Dutch Hospital Anxiety and Depression Scale (HADS) is used for all participants at baseline measurement, after the intervention and at 3 months follow-up as a general measure of emotional distress and contains two sub-scales: anxiety and depression. Each sub-scale consists of 7 items, which are rated on a 0 to 3 point rating scale. Sub-scale scores ≥ 8 might indicate the presence of a depressive disorder or an anxiety disorder. Reliability and validity are adequate for several clinical populations, including multiple sclerosis and acquired brain injury.
    Time Frame
    6-9 months
    Title
    Health-related quality of life (HR-QoL)
    Description
    The EQ-5D-5L is used for all participants at baseline measurement, after the intervention and at 3 months follow-up as a measurement for HR-QoL. The EQ-5D-5L consists of the 5-item EQ-5D index (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and a visual analogue scale (EQ VAS). Psychometric properties of the Dutch version showed to be good. The five EQ-5D index items are summarized into one weighted overall score, which runs from 0 for the value of death to 1.00 for full health. The EQ VAS ranges from 0 to 100 (worst to best imaginable health state). For the general Dutch population average EQ-5D index = 0.843 and average EQ VAS = 81.36.
    Time Frame
    6-9 months
    Title
    Fatigue
    Description
    The Fatigue Assessment Scale (FAS) is used for all participants at baseline measurement, after the intervention and at 3 months follow-up as a measurement for fatigue. The FAS is a simple and short self-administered questionnaire to assess chronic fatigue. Patients' agreement with 10 statements is rated on a 5 points Likert-scale, ranging from 1 ("never") to 5 ("always"). Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest.
    Time Frame
    6-9 months
    Title
    Coping
    Description
    The Coping Inventory for Stressful Situations (CISS-Short Form) is used at baseline measurement to measure coping styles of all participants. The short version of the CISS is used as a measure of coping with stressful situations. It has 21 items which are rated on a 1 to 5 point rating scale. It contains 3 subscales: task-oriented, emotion-oriented, and avoidance-oriented coping.
    Time Frame
    1 month
    Title
    Personality traits neuroticism and extraversion
    Description
    The Eysenck Personality Questionnaire Brief Version (EPQ-BV) is used at baseline measurement to measure level of neuroticism and level of extraversion of all participants. The EPQ-BV is a revised version of the EPQ-S to measure individuals on two primary personality traits in Eysenck's personality theory (1990). It consists of two measures, one for extraversion (12 items) and one for neuroticism (12 items).
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Chantal Luijkx
    Phone
    010-2412412
    Email
    c.luijkx@erasmusmc.nl
    First Name & Middle Initial & Last Name or Official Title & Degree
    Majanka Heijenbrok
    Email
    m.heijenbrok@erasmusmc.nl
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gerard Ribbers, Professor
    Organizational Affiliation
    Professor Rehabilitation Medicine and chair of the department
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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