COVID-19CO-TRAINERNCT05831839
Computerized Training of Attention and Working Memory in Post COVID-19 Patients With Cognitive Complaints
A study testing RehaCom in people with COVID-19 and Cognitive Impairment, run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Cognitive Impairment, Cognition Disorder
- What is being tested?
- RehaCom
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2023to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Computerized Training of Attention and Working Memory in Post COVID-19 Patients With Cognitive Complaints
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.
Read the 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.
- Conditions
- COVID-19, Cognitive Impairment, Cognition Disorder, Memory Disorders, Attention Deficit, Memory Impairment
- Being tested
- RehaCom
- Keywords
- COVID-19, cognitive failure, attention, memory, cognitive training, computerized training
- Medical subject headings
- COVID-19, Cognitive Dysfunction, Cognition Disorders, Memory Disorders, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehaComDevice
computerized cognitive training
| Study group | Role | What they receive |
|---|---|---|
| Cognitive training 1 | Other | Randomized wait-list controlled pilot trial Receives: Device: RehaCom |
| Cognitive training 2 | Other | Randomized wait-list controlled pilot trial Receives: Device: RehaCom |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6-9 months
Secondary outcomes (6)
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.
Measured: 6-9 months
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.
Measured: 6-9 months
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.
Measured: 6-9 months
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.
Measured: 6-9 months
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.
Measured: 1 month
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).
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start1 Dec 2023
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chantal Luijkx, Erasmus Medical Center
- Investigators
- Gerard Ribbers, Professor, Study chair, Professor Rehabilitation Medicine and chair of the department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05831839
- Sponsor's protocol ID
- NL84105.078.23
- Acronym
- CO-TRAINER
- Status last verified
- Mar 2024
- First submitted
- 20 Apr 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Computerized Training of Attention and Working Memory in Post COVID-19 Patients With Cognitive Complaints
- ClinicalTrials.gov ID
- NCT05831839
- Acronym / sponsor ID
- CO-TRAINER / NL84105.078.23
- Conditions
- COVID-19, Cognitive Impairment, Cognition Disorder, Memory Disorders, Attention Deficit, Memory Impairment
- Keywords
- COVID-19, cognitive failure, attention, memory, cognitive training, computerized training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Cognitive training 1 | Other | Device: RehaComRandomized wait-list controlled pilot trial |
| Cognitive training 2 | Other | Device: RehaComRandomized wait-list controlled pilot trial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- A potential participant who meets any of the following criteria will be excluded from participation in this study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RehaComcomputerized cognitive training | Device | Cognitive training 1, Cognitive training 2 |
Primary outcome
General cognition
Time frame: 3 months
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
Time frame: 6-9 months
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
Time frame: 6-9 months
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 secondary outcomes
Subjective cognitive complaints
Time frame: 6-9 months
Anxiety and depression
Time frame: 6-9 months
Health-related quality of life (HR-QoL)
Time frame: 6-9 months
Fatigue
Time frame: 6-9 months
Coping
Time frame: 1 month
Personality traits neuroticism and extraversion
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerard Ribbers, Professor study chair
Professor Rehabilitation Medicine and chair of the department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RehaCom in people with COVID-19 and Cognitive Impairment, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General cognition (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.