Improving Cognitive Health in COVID-19 Survivors
Purpose
The primary objective of this study is to investigate the efficacy of AKL-T01, a remotely-delivered digital cognitive intervention, relative to a waitlist control in improving cognitive functioning in COVID-19 survivors.
Conditions
- Cognitive Dysfunction
- Covid19
Eligibility
- Eligible Ages
- Between 18 Years and 89 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Male or female 18-89 years of age - Documentation of a deficit in cognitive function (score > 1 standard deviation below normal range) compared to age-adjusted normative data) on at least one screening measure of attention and executive function (Oral Trail Making Test, Stroop Test, or FrSBe) - Previous diagnosis of COVID-19 confirmed via SARS-CoV-2 polymerase chain reaction (PCR) test (or reported experience of COVID-19 symptoms with a documented positive antibody test or clinical diagnosis based on symptoms and accompanying physician's note) documented in the electronic medical record or in other existing medical records - Access to and self-report of ability to connect wireless devices to a functional wireless network. - Ability to follow written and verbal instructions (English) as assessed by the PI and/or coinvestigator. - Able to comply with all testing and study requirements and willingness to participate in the full study duration
Exclusion Criteria
- History of neurologic disorder prior to COVID-19 diagnosis, such as Parkinson's disease, multiple sclerosis, Alzheimer's disease, stroke, brain tumor, or dementia. - History of severe mental illness (e.g., schizophrenia, psychosis, history of suicide attempt in the last year) or substance use disorder, recent history (in the past year) of symptoms of psychosis - Participant is currently considered at risk for attempting suicide by the Investigator, has made a suicide attempt within the past year, or is currently demonstrating active suicidal ideation or self-injurious behavior. - Motor condition (e.g., physical deformity of the hands/arms) that prevents game playing as reported by the participant or observed by the Investigator - Recent history (within 6 months prior to screening/baseline) of substance use disorder - History of seizures (excluding febrile seizures), a tic disorder, significant tics, a current diagnosis of Tourette's Disorder. - Color blindness as determined by self-report - Regular use of psychoactive drugs other than antidepressants or benzodiazepines, including stimulants that in the opinion of the Investigator may confound study data/assessments. - Any other acute medical condition that may interfere with participation or interpretation of the results - Previous exposure to AKL-T01.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- This study is a randomized clinical trial designed to compare efficacy of the AKL-T01 intervention relative to a waitlist control in patients who were infected with COVID-19. Participants will be randomized to the AKL-T01 or a waitlist control. We will use a waitlist design; at the end of the intervention period, participants in the control group will have the option to receive the 6-week AKL-T01 intervention.
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
- Masking Description
- Participants and care managers will be instructed not to reveal the group assignment to the member of the research team conducting assessments. Following the completion of recruitment, data analysts will be provided with the data for the arms simply labelled as "Group A" and "Group B" to avoid bias. These generic labels will be unmasked only after completion of all the planned statistical analyses described below. Participants in the waitlist control arm who begin the intervention at the end of the waitlist period will have different assessors for the initial 6-week control procedures and the subsequent 6-week intervention period so as to maintain the blind.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental AKL-T01 Intervention |
Participants in the experimental group will complete 6 weeks of the AKL-T01 intervention. Participants enrolled in the intervention arm will play the game via an iPad application for 20-25 minutes daily for at least 5 days a week (but up to 7 days a week). Participants will also have weekly check-in visits via phone or a secure HIPAA compliant videoconferencing platform (Zoom) with a care manager, who will monitor mood symptoms and gameplay adherence. |
|
|
No Intervention Waitlist Control |
Participants in the Waitlist Control arm will not be engaging in any active control condition. Participants in the waitlist control arm will continue any ongoing self- or provider-based cognitive intervention (or no intervention) during the initial 6-week waitlist period. Participants will also have weekly check-in visits via phone or a secure HIPAA compliant videoconferencing platform (Zoom) with a care manager, who will monitor mood symptoms. The control arm will be offered the intervention at the end of 6 weeks waitlist period to ensure all participants ultimately have access to the intervention. |
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Recruiting Locations
More Details
- NCT ID
- NCT04843930
- Status
- Completed
- Sponsor
- Weill Medical College of Cornell University
Detailed Description
Emerging evidence suggests a subgroup of survivors of COVID- 19 have residual difficulties with cognition and daily functioning. These deficits are pronounced in cognitive domains including attention, learning and executive skills, and may continue to impact quality of life after recovery from other COVID-19 symptoms. This study aims to investigate the efficacy of AKL-T01 (Akili Interactive), a remotely-delivered digital cognitive intervention, in targeting and improving cognition and functional outcomes in individuals recovering from COVID-19. The efficacy of the AKL-T01 intervention will be measured relative to a waitlist control group.