COVID-19COPERIA-COGNCT05629897
Randomised Clinical Trial to Evaluate the Efficacy of an Online Cognitive Rehabilitation Programme (COPERIA-COG) for Patients With Persistent COVID-19
A study testing Sessions of cognitive stimulation in people with COVID-19 and Neuro-Degenerative Disease, run by Fundacin Biomedica Galicia Sur at 2 sites in Spain.
Trial summary
The pandemic caused by SARS-CoV-2 infection has led to the emergence of diffuse and heterogeneous persistent symptoms in addition to the well-known acute symptoms, which have come to be referred to as persistent COVID. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- COVID-19, Neuro-Degenerative Disease, Psychological
- What is being tested?
- Sessions of cognitive stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 2 sitesSpain
- Study dates
- 14 Dec 2022to Nov 2023
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 and ≤70 years old.
- Read and write.
- Diagnosis of persistent COVID according to WHO criteria.
- The patient reports cognitive dysfunction with self-assessed impact of at least grade 2 on the Post-Covid Functional Status (Chile) (Klok et al., 2020, Lorca et al., 2021).
- The patient does not present cognitive dysfunction to a degree equal to or greater than 1.5 SD assessed in the psychology consultation by means of the following instruments: RAVLT Rey Auditory Verbal Learning Test (Schmidt, 1996). Subtests of the Number Key, Symbol Search and Digit Span of the Scale for Measuring Adult and Adolescent Intelligence (WAIS III) (Wechsler, 1999). TMT Stroke Test (Reitan \& Wolfson, 1993). Verbal fluency tests (Benton et al., 1989). In case of scores above 1.5 SD below the normative mean, they will be excluded from the study and referred for treatment to the Brain Injury Unit (Winblad et al., 2004).
- Patients with capacity to consent and agree to participate in the study.
- Patients who know how to use and have a Smartphone or Tablet and an Internet connection.
Who cannot join
- Minors or persons legally incapacitated.
- Previous neurological or psychiatric pathology involving neuropsychological compromise.
- Active Covid19 infection.
- Home oxygen therapy > 16 hours or home CPAP-BiPAP.
- Be undergoing another cognitive rehabilitation process at the time of inclusion.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Complexo Hospitalario Universitario de Ourense
Ourense, 32002
Alejandro García Caballero, MD, alejandro.alberto.garcia.caballero@sergas.es
Alejandro García Caballero, MD
Galicia Sur Health Research Institute (IISGS) - Hospital Álvaro Cunqueiro
Vigo, Pontevedra, 36213
About this study
The pandemic caused by SARS-CoV-2 infection has led to the emergence of diffuse and heterogeneous persistent symptoms in addition to the well-known acute symptoms, which have come to be referred to as persistent COVID. In particular, one of the frequent complaints of patients with a previous diagnosis of COVID is impaired cognitive ability.
Various cognitive rehabilitation programmes have benefited from incorporating the methodology of so-called "serious games" are designed to train or change behaviour while entertaining players. The design of the online rehabilitation programme (COPERIA-COG) took into account the principles of neuropsychological rehabilitation (neuropsychological pre-assessment, operational goal setting, task prioritisation and continuous feedback system) and combined different individual techniques, such as restitution and compensation. Patients treated with COPERIA-COG will show neuropsychological improvements in verbal memory compared to the waiting list group.
Read more
The main objective is to identify differences in long-term memory in patients treated with COPERIA-COG vs. patients on the waiting list. For this purpose, both groups will be evaluated through RAVLT, taking the long-term memory subtest as a reference, comparing the results before and after the active group performs the online training with COPERIA-COG.
The COPERIA platform is a cloud platform that provides a range of ICT tools for monitoring and aiding the recovery of patients with persistent COVID. To achieve this goal, the platform will store patient data to which Artificial Intelligence techniques will be applied to perform an assessment of the affected person.
- Being tested
- Sessions of cognitive stimulation
- Keywords
- Cognitive rehabilitation, SARS-CoV-2, COVID, Long-term memory, Verbal learning, RAVLT
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sessions of cognitive stimulationOther
40 sessions of cognitive stimulation of approximately 20 minutes duration per session are carried out, using the COPERIA platform.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | They will perform an initial test of processing speed, attentional span and executive control. After this test, they will start the training programme. It consists of 40 sessions of cognitive stimulation, distributed over 8 weeks of treatment with a frequency of five sessions per week. In the last session, a final test will be performed, the same as the initial one. Receives: Other: Sessions of cognitive stimulation |
| Waiting list | No intervention | They will perform an initial test of processing speed, attentional span and executive control. In the last session, 8 weeks after the initial test, a final test will be performed, the same as the initial one. They will have the opportunity to perform the same training as the experimental group after performing the final test. At 8 weeks, patients on the waiting list will be taught, if the wish, how to use the platform to perform the stimulation. They will be offered cognitive training with COPERIA-COG under the same conditions, periodicity, automatic reminders and calls from the psychologist as in the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
RAVLT Rey Auditory Verbal Learning Test
An instrument that has proven useful in assessing verbal learning and memory. Easily administered test that assesses immediate memory span, new learning, susceptibility to interference and recognition memory.
Measured: 8 weeks
Secondary outcomes (6)
Subtests of the Number Key, Symbol Search and Digit Search Scale for Measuring Adult and Adolescent Intelligence (WAIS III)
They allow the calculation of the processing speed index. The Spanish adaptation of the WAIS-III was used. Reliability coefficients (two halves) range from .77 to .96.
Measured: 8 weeks
Trail Making Test (TMT)
The test consists of two parts, A and B. Part A assesses sustained attention, processing speed, motor skills and visuospatial visual search skills. Part B assesses alternating attention and cognitive flexibility. Its reliability is between 0.86% and 0.94% and its reliability is .66. Neuronorm scales are used in Spain
Measured: 8 weeks
Verbal fluency tests
The investigators will use the phonemic fluency test, a task of oral production of words before phonetic commands (P-M-R) and the semantic fluency test (animals), a task of linguistic production that requires the implementation of the mechanisms of access to the lexicon. Neuronorm scales are used in Spain. The scale is made with scalar scores from 2 to 18, where 2 is the worst score and 18 is the best.
Measured: 8 weeks
Memory Failures Everyday-30 (MFE-30)
It is a 30-item questionnaire that explores the relationships between the occurrence of memory complaints, prefrontal symptomatology and perceived stress.
The scale has values between 0-120. Where 120 is indicative of more severe impairment in daily functioning and 0 indicates optimal functioning.
Measured: 8 weeks
Hospital Anxiety and Depression Scale (HADS Scale)
The Hospital Anxiety and Depression Scale was originally designed as a screening instrument for the detection of patients with affective disorders in response to the drawbacks of widely used instruments such as the GHQ. It consists of two sets of seven items -one representing the anxiety subscale and the other the depression subscale- both of which are psychopathological concepts of anxiety and depression independent.
There are two subscales (anxiety and depression) with a score from 0 to 21 each. Scores greater than 10 are considered indicative of morbidity, scores between 8-10 are considered bordeline and scores less than 8 indicate no significant morbidity.
Measured: 8 weeks
Adherence to online treatment
Number of games played and total time of use will be extracted from the platform, analysing whether there are differences by age or gender or severity.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start14 Dec 2022 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (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.
- 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
- Parallel groups
- Model description
- Intervention or waiting list
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacin Biomedica Galicia Sur
- Sponsor type
- University, hospital or other
- Collaborators
- Centro de Investigación Biomédica en Red de Salud Mental, Galician South Health Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629897
- Sponsor's protocol ID
- COPERIA-COG
- Acronym
- COPERIA-COG
- Status last verified
- Nov 2022
- First submitted
- 18 Nov 2022
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Clinical Trial to Evaluate the Efficacy of an Online Cognitive Rehabilitation Programme (COPERIA-COG) for Patients With Persistent COVID-19
- ClinicalTrials.gov ID
- NCT05629897
- Acronym / sponsor ID
- COPERIA-COG / COPERIA-COG
- Keywords
- Cognitive rehabilitation, SARS-CoV-2, COVID, Long-term memory, Verbal learning, RAVLT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Fundacin Biomedica Galicia SurUniversity, hospital or other
- Collaborators
- Centro de Investigación Biomédica en Red de Salud Mental, Galician South Health Research Institute
- Study start
- 14 Dec 2022 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 29 Nov 2022 (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.
The pandemic caused by SARS-CoV-2 infection has led to the emergence of diffuse and heterogeneous persistent symptoms in addition to the well-known acute symptoms, which have come to be referred to as persistent COVID. In particular, one of the frequent complaints of patients with a previous diagnosis of COVID is impaired cognitive ability.
Various cognitive rehabilitation programmes have benefited from incorporating the methodology of so-called "serious games" are designed to train or change behaviour while entertaining players. The design of the online rehabilitation programme (COPERIA-COG) took into account the principles of neuropsychological rehabilitation (neuropsychological pre-assessment, operational goal setting, task prioritisation and continuous feedback system) and combined different individual techniques, such as restitution and compensation. Patients treated with COPERIA-COG will show neuropsychological improvements in verbal memory compared to the waiting list group.
The main objective is to identify differences in long-term memory in patients treated with COPERIA-COG vs. patients on the waiting list. For this purpose, both groups will be evaluated through RAVLT, taking the long-term memory subtest as a reference, comparing the results before and after the active group performs the online training with COPERIA-COG.
The COPERIA platform is a cloud platform that provides a range of ICT tools for monitoring and aiding the recovery of patients with persistent COVID. To achieve this goal, the platform will store patient data to which Artificial Intelligence techniques will be applied to perform an assessment of the affected person.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention or waiting list
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Sessions of cognitive stimulationThey will perform an initial test of processing speed, attentional span and executive control. After this test, they will start the training programme. It consists of 40 sessions of cognitive stimulation, distributed over 8 weeks of treatment with a frequency of five sessions per week. In the last session, a final test will be performed, the same as the initial one. |
| Waiting list | No intervention | –They will perform an initial test of processing speed, attentional span and executive control. In the last session, 8 weeks after the initial test, a final test will be performed, the same as the initial one. They will have the opportunity to perform the same training as the experimental group after performing the final test. At 8 weeks, patients on the waiting list will be taught, if the wish, how to use the platform to perform the stimulation. They will be offered cognitive training with COPERIA-COG under the same conditions, periodicity, automatic reminders and calls from the psychologist as in the intervention group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 and ≤70 years old.
- Read and write.
- Diagnosis of persistent COVID according to WHO criteria.
- The patient reports cognitive dysfunction with self-assessed impact of at least grade 2 on the Post-Covid Functional Status (Chile) (Klok et al., 2020, Lorca et al., 2021).
- The patient does not present cognitive dysfunction to a degree equal to or greater than 1.5 SD assessed in the psychology consultation by means of the following instruments: RAVLT Rey Auditory Verbal Learning Test (Schmidt, 1996). Subtests of the Number Key, Symbol Search and Digit Span of the Scale for Measuring Adult and Adolescent Intelligence (WAIS III) (Wechsler, 1999). TMT Stroke Test (Reitan \& Wolfson, 1993). Verbal fluency tests (Benton et al., 1989). In case of scores above 1.5 SD below the normative mean, they will be excluded from the study and referred for treatment to the Brain Injury Unit (Winblad et al., 2004).
Key exclusion criteria (5 listed)
- Minors or persons legally incapacitated.
- Previous neurological or psychiatric pathology involving neuropsychological compromise.
- Active Covid19 infection.
- Home oxygen therapy > 16 hours or home CPAP-BiPAP.
- Be undergoing another cognitive rehabilitation process at the time of inclusion.
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 |
|---|---|---|
| Sessions of cognitive stimulation40 sessions of cognitive stimulation of approximately 20 minutes duration per session are carried out, using the COPERIA platform. | Other | Intervention |
Primary outcome
RAVLT Rey Auditory Verbal Learning Test
Time frame: 8 weeks
An instrument that has proven useful in assessing verbal learning and memory. Easily administered test that assesses immediate memory span, new learning, susceptibility to interference and recognition memory.
6 secondary outcomes
Subtests of the Number Key, Symbol Search and Digit Search Scale for Measuring Adult and Adolescent Intelligence (WAIS III)
Time frame: 8 weeks
Trail Making Test (TMT)
Time frame: 8 weeks
Verbal fluency tests
Time frame: 8 weeks
Memory Failures Everyday-30 (MFE-30)
Time frame: 8 weeks
Hospital Anxiety and Depression Scale (HADS Scale)
Time frame: 8 weeks
Adherence to online treatment
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sessions of cognitive stimulation in people with COVID-19 and Neuro-Degenerative Disease, run by Fundacin Biomedica Galicia Sur at 2 sites in Spain.
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 7 inclusion and 5 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 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
Contact Alejandro García Caballero, MD (988 38 55 00, alejandro.alberto.garcia.caballero@sergas.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RAVLT Rey Auditory Verbal Learning Test (time frame: 8 weeks). 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 2 Dec 2022.