Clinical trial NCT05831839: Computerized Training of Attention and Working Memory in Post COVID-19 Patients With Cognitive Complaints
Official title: Effectiveness of Computerized Training of Attention and Working Memory in Post COVID-19 Patients With Cognitive Complaints
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
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
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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)
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: General cognition
timeFrame: 3 months
measure: Attention
timeFrame: 6-9 months
measure: Working memory
timeFrame: 6-9 months
Secondary outcomes:
measure: Subjective cognitive complaints
timeFrame: 6-9 months
measure: Anxiety and depression
timeFrame: 6-9 months
measure: Health-related quality of life (HR-QoL)
timeFrame: 6-9 months
measure: Fatigue
timeFrame: 6-9 months
measure: Coping
timeFrame: 1 month
measure: Personality traits neuroticism and extraversion
timeFrame: 1 month
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Rijndam Rehabilitation
state: Zuid-Holland
Study officials:
affiliation: Professor Rehabilitation Medicine and chair of the department
name: Gerard Ribbers, Professor
role: STUDY_CHAIR
References: