Ignite Creation Date:
2024-05-06 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05831839
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-13
First Post:
2023-04-20
Brief Title:
Computerized Training of Attention and Working Memory in Post COVID-19 Patients With Cognitive Complaints
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
Effectiveness of Computerized Training of Attention and Working Memory in Post COVID-19 Patients With Cognitive Complaints
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CO-TRAINER
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 NL7425207820 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 timesweek 15 - 30 minutessession
Main study parametersendpoints 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
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 NL7425207820 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 timesweek 15 - 30 minutessession
Main study parametersendpoints 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None