Cognitive Dysfunction, Covid19
Conditions
Keywords
Covid19, Cognitive Dysfunction, Attention Disturbances, Cognitive Change
Brief summary
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.
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.
Interventions
DEVICEAKL-T01
AKL-T01 will be administered as a 6-week intervention. It is an algorithmically delivered iPad-based video game designed to improve cognitive health by targeting attention and attentional control processes.
Sponsors
Akili Interactive Labs, Inc.
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cognitive Function, as Measured by Number Correct on the Digit Symbol Matching Task | Baseline and Post Treatment (6 weeks) | Change in cognitive function in the experimental group vs. controls, measured by score on the Digit Symbol Matching Task, a timed measure of attention and processing speed. Participants are asked to correctly match pairs of shapes and numbers. Scores exceeding the normative mean number correct (mean = 65.79) reflect better task performance and scores below the normative mean reflect poorer performance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cognitive Performance, as Measured by Proportion Correct on the Multiple Object Tracking Test | Baseline and Post Treatment (6 weeks) | Change in scores on the Multiple Object Tracking task in the experimental group vs. controls This task measures sustained attention, cognitive control, and working memory, and requires participants to remember and track a set of target circles as they move around the screen, among a larger set of identical distractor circles. The outcome measure is the proportion of dots that a participant was able to track and identify successfully (on a scale of 0 to 1, with 0 being no dots and 1 being all of the dots). Higher proportion reflects better performance, while lower proportions reflect poorer task performance. |
| Change in Cognitive Performance, as Measured by Digit Span on the Digit Span Backwards Test | Baseline and Post Treatment (6 weeks) | Change in scores on the Test My Brain (TMT) Digit Span Backwards task in the experimental group vs. controls. This task measures sustained attention and working memory. Participants are shown a series of numbers and asked to reproduce them in reverse order. Higher digit spans, defined as those exceeding the population mean (M = 5.98) reflect better performance, while lower digit spans reflect poorer task performance. |
| Change in Cognitive Performance, as Measured by the Simple Reaction Time Test | Baseline and Post Treatment (6 weeks) | Change in scores on the Simple Reaction Time task in the experimental group vs. controls This task measures simple reaction time and psychomotor speed, and requires participants to press a key whenever a green square appears. Faster response times indicate better performance than slower response times. |
| Change in Cognitive Performance, as Measured by the Choice Reaction Time Test | Baseline and Post Treatment (6 weeks) | Change in scores on the Choice Reaction Time task in the experimental group vs. controls This task measures processing speed and cognitive control, and requires participants to indicate the direction of an arrow that is a different color from the rest. Faster response times indicate better performance than slower response times. |
| Change in Daily Functioning, as Measured by the NeuroQOL Cognitive Function Scale | Baseline and Post Treatment (6 weeks) | Change in scores on the NeuroQOL Cognitive Function scale in the experimental group vs. controls. The NeuroQOL Cognitive Function scale is a 28-item self-report measure of daily functioning. Higher scores, defined as those exceeding the population mean (mean (SD) = 50.09 (10.23)), reflect better self-reported daily cognitive abilities, while lower scores, defined as those falling below the population mean, reflect poorer self-reported daily cognitive abilities. |
| Change in Cognitive Performance, as Measured by D-prime on the Gradual Onset Continuous Performance Test | Baseline and Post Treatment (6 weeks) | This task measures sustained attention and response inhibition, and requires participants to respond to target stimuli and ignore distractors. Performance is measured by d-prime, a measure of memory sensitivity and discrimination. D-prime is based on the calculation of hits (i.e., responding to a target when a target is present), misses (i.e., not responding when a target is present), false alarms (i.e., responding to a target when a distractor is present), and correct rejections (i.e., not responding when a distractor is present). D-prime scores range from 0 (chance) to 4.65 (based on hit rate of 0.99 and false alarm rate of 0.01). Greater d-prime scores reflect better performance than lower d-prime scores. |
| Change in Cognitive Performance, as Measured by Percent Correct on the Visual Paired Associates Task | Baseline and Post Treatment (6 weeks) | Change in scores on the Visual Paired Associates Task in the experimental group vs. controls. This task measures visual memory, and requires participants to learn and identify image pairs. The outcome measure is proportion of image pairs successfully recalled (on a scale of 0 to 1, with 0 being no image pairs and 1 being all of the image pairs). A higher proportion of correct image pairs reflects better performance than a lower proportion of correct image pairs. |
| Change in Overall Daily Functioning, as Measured by the World Health Organization Disability Assessment Scale (WHODAS) 2.0 | Baseline and Post Treatment (6 weeks) | Change in total score on the 36-item WHODAS in the experimental group vs. controls. The WHODAS 2.0 assesses the following domains of functioning: cognition, mobility, getting along, self-care, participation, and life activities. Scores range from 0 (no disability) to 100 (maximum disability), with higher scores reflecting a greater degree of overall functional disability. |
| Change in Cognitive Performance, as Measured by Proportion Correct on the Letter-Number Switching Test | Baseline and Post Treatment (6 weeks) | This task measures sustained attention and set-shifting, and requires participants to switch between responses to letters and numbers. The outcome measure is proportion of correct switch trials, indicating that participants successfully switched from a letter response to a number response, or vice versa (on a scale of 0 to 1, with 0 being no correct switches and 1 being correct switches on all switch trials). Higher proportion correct for switch trials indicates better set-shifting performance, while lower proportion correct indicates worse set-shifting performance. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited between July 2021 (date of first enrollment: 7/13/2021) and December 2022 (date of final enrollment: 12/7/2022). Participants were recruited through facilities of the Manhattan Campuses of NewYork-Presbyterian Hospital (NYP)/Weill Cornell Medicine (WCM), as well as the NewYork-Presbyterian Westchester Behavioral Health Center. Participants were also recruited through community advertisement in the Greater New York City area.
Pre-assignment details
Note that the final participant was consented and enrolled on 12/7/2022, but did not have their first study visit until 12/20/2022 due to scheduling constraints. The final 6-week primary endpoint for this participant was collected on 2/6/2023.
Participants by arm
| Arm | Count |
|---|---|
| AKL-T01 Intervention Participants in the intervention arm complete 6 weeks of the AKL-T01 intervention. Participants complete the intervention (an algorithmically delivered iPad-based video game designed to improve cognitive health by targeting attention and attentional control processes) for 20-25 minutes daily for at least 5 days a week (but up to 7 days a week). Participants also have weekly check-in visits with a care manager to complete assessments and monitor mood symptoms and gameplay adherence. | 49 |
| Waitlist Control Participants in the waitlist control arm will not be engaging in any active control condition. Participants will also have weekly check-in visits with a care manager to complete assessments and 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. | 49 |
| Total | 98 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Randomization | Withdrawal by Subject | 6 | 6 | 0 | 0 |
| Week 16 Follow-Up | Lost to Follow-up | 0 | 0 | 2 | 0 |
| Week 6 Assessment | Adverse Event | 3 | 0 | 0 | 0 |
| Week 6 Assessment | Withdrawal by Subject | 2 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Waitlist Control | Total | AKL-T01 Intervention |
|---|---|---|---|
| Age, Continuous | 46.8 years STANDARD_DEVIATION 16.7 | 48.1 years STANDARD_DEVIATION 16.9 | 49.5 years STANDARD_DEVIATION 17.2 |
| COVID Treatment Category ER Admission | 4 Participants | 6 Participants | 2 Participants |
| COVID Treatment Category ICU | 5 Participants | 8 Participants | 3 Participants |
| COVID Treatment Category Inpatient | 2 Participants | 3 Participants | 1 Participants |
| COVID Treatment Category No Treatment | 21 Participants | 47 Participants | 26 Participants |
| COVID Treatment Category Other | 5 Participants | 6 Participants | 1 Participants |
| COVID Treatment Category Outpatient | 12 Participants | 28 Participants | 16 Participants |
| Education | 16.7 years STANDARD_DEVIATION 2.2 | 16.8 years STANDARD_DEVIATION 2.5 | 16.9 years STANDARD_DEVIATION 2.8 |
| FrSBe Total Score (after COVID) | 109.0 score on a scale STANDARD_DEVIATION 20.8 | 110.0 score on a scale STANDARD_DEVIATION 22.3 | 111.0 score on a scale STANDARD_DEVIATION 23.8 |
| FrSBe Total Score (before COVID) | 80.4 score on a scale STANDARD_DEVIATION 16.4 | 79.9 score on a scale STANDARD_DEVIATION 17 | 79.5 score on a scale STANDARD_DEVIATION 17.7 |
| Oral Trails A | 8.3 seconds STANDARD_DEVIATION 2.4 | 8.6 seconds STANDARD_DEVIATION 2.5 | 8.9 seconds STANDARD_DEVIATION 2.6 |
| Oral Trails B | 32.6 seconds STANDARD_DEVIATION 16.5 | 32.3 seconds STANDARD_DEVIATION 15.8 | 32.0 seconds STANDARD_DEVIATION 15.3 |
| Race/Ethnicity, Customized Asian | 5 Participants | 8 Participants | 3 Participants |
| Race/Ethnicity, Customized Black | 12 Participants | 22 Participants | 10 Participants |
| Race/Ethnicity, Customized Hispanic/Latinx | 4 Participants | 10 Participants | 6 Participants |
| Race/Ethnicity, Customized More Than One Race | 4 Participants | 6 Participants | 2 Participants |
| Race/Ethnicity, Customized Other / Not Reported | 1 Participants | 4 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 23 Participants | 48 Participants | 25 Participants |
| Region of Enrollment United States | 49 participants | 98 participants | 49 participants |
| Sex: Female, Male Female | 39 Participants | 77 Participants | 38 Participants |
| Sex: Female, Male Male | 10 Participants | 21 Participants | 11 Participants |
| Stroop Color-Word t-score | 41.8 t-score STANDARD_DEVIATION 19.5 | 40.7 t-score STANDARD_DEVIATION 19.4 | 39.6 t-score STANDARD_DEVIATION 19.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 55 | 0 / 46 | 0 / 2 |
| other Total, other adverse events | 5 / 55 | 2 / 55 | 2 / 46 | 0 / 2 |
| serious Total, serious adverse events | 0 / 55 | 0 / 55 | 0 / 46 | 0 / 2 |
Outcome results
Primary
Change in Cognitive Function, as Measured by Number Correct on the Digit Symbol Matching Task
Change in cognitive function in the experimental group vs. controls, measured by score on the Digit Symbol Matching Task, a timed measure of attention and processing speed. Participants are asked to correctly match pairs of shapes and numbers. Scores exceeding the normative mean number correct (mean = 65.79) reflect better task performance and scores below the normative mean reflect poorer performance.
Time frame: Baseline and Post Treatment (6 weeks)
Population: Analysis of outcome measure excludes participants who did not complete this task / timepoint and performance-based outliers.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| AKL-T01 Intervention | Change in Cognitive Function, as Measured by Number Correct on the Digit Symbol Matching Task | Baseline | 63.0 number of correct matches |
| AKL-T01 Intervention | Change in Cognitive Function, as Measured by Number Correct on the Digit Symbol Matching Task | Week 6 | 67.8 number of correct matches |
| Waitlist Control | Change in Cognitive Function, as Measured by Number Correct on the Digit Symbol Matching Task | Baseline | 63.5 number of correct matches |
| Waitlist Control | Change in Cognitive Function, as Measured by Number Correct on the Digit Symbol Matching Task | Week 6 | 69.0 number of correct matches |
Comparison: Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control.p-value: 0.54Mixed Models Analysis
Secondary
Change in Cognitive Performance, as Measured by Digit Span on the Digit Span Backwards Test
Change in scores on the Test My Brain (TMT) Digit Span Backwards task in the experimental group vs. controls. This task measures sustained attention and working memory. Participants are shown a series of numbers and asked to reproduce them in reverse order. Higher digit spans, defined as those exceeding the population mean (M = 5.98) reflect better performance, while lower digit spans reflect poorer task performance.
Time frame: Baseline and Post Treatment (6 weeks)
Population: Analysis of outcome measure excludes participants who did not complete this task / timepoint and performance-based outliers.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| AKL-T01 Intervention | Change in Cognitive Performance, as Measured by Digit Span on the Digit Span Backwards Test | Baseline | 4.7 digit span |
| AKL-T01 Intervention | Change in Cognitive Performance, as Measured by Digit Span on the Digit Span Backwards Test | Week 6 | 5.6 digit span |
| Waitlist Control | Change in Cognitive Performance, as Measured by Digit Span on the Digit Span Backwards Test | Baseline | 4.9 digit span |
| Waitlist Control | Change in Cognitive Performance, as Measured by Digit Span on the Digit Span Backwards Test | Week 6 | 5.7 digit span |
Comparison: Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control.p-value: 0.45Mixed Models Analysis
Secondary
Change in Cognitive Performance, as Measured by D-prime on the Gradual Onset Continuous Performance Test
This task measures sustained attention and response inhibition, and requires participants to respond to target stimuli and ignore distractors. Performance is measured by d-prime, a measure of memory sensitivity and discrimination. D-prime is based on the calculation of hits (i.e., responding to a target when a target is present), misses (i.e., not responding when a target is present), false alarms (i.e., responding to a target when a distractor is present), and correct rejections (i.e., not responding when a distractor is present). D-prime scores range from 0 (chance) to 4.65 (based on hit rate of 0.99 and false alarm rate of 0.01). Greater d-prime scores reflect better performance than lower d-prime scores.
Time frame: Baseline and Post Treatment (6 weeks)
Population: Analysis of outcome measure excludes participants who did not complete this task / timepoint and performance-based outliers.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| AKL-T01 Intervention | Change in Cognitive Performance, as Measured by D-prime on the Gradual Onset Continuous Performance Test | Baseline | 2.3 d-prime |
| AKL-T01 Intervention | Change in Cognitive Performance, as Measured by D-prime on the Gradual Onset Continuous Performance Test | Week 6 | 2.4 d-prime |
| Waitlist Control | Change in Cognitive Performance, as Measured by D-prime on the Gradual Onset Continuous Performance Test | Baseline | 2.3 d-prime |
| Waitlist Control | Change in Cognitive Performance, as Measured by D-prime on the Gradual Onset Continuous Performance Test | Week 6 | 2.4 d-prime |
Comparison: Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control.p-value: 0.6Mixed Models Analysis
Secondary
Change in Cognitive Performance, as Measured by Percent Correct on the Visual Paired Associates Task
Change in scores on the Visual Paired Associates Task in the experimental group vs. controls. This task measures visual memory, and requires participants to learn and identify image pairs. The outcome measure is proportion of image pairs successfully recalled (on a scale of 0 to 1, with 0 being no image pairs and 1 being all of the image pairs). A higher proportion of correct image pairs reflects better performance than a lower proportion of correct image pairs.
Time frame: Baseline and Post Treatment (6 weeks)
Population: Analysis of outcome measure excludes participants who did not complete this task / timepoint and performance-based outliers.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| AKL-T01 Intervention | Change in Cognitive Performance, as Measured by Percent Correct on the Visual Paired Associates Task | Baseline | 0.56 proportion of image pairs |
| AKL-T01 Intervention | Change in Cognitive Performance, as Measured by Percent Correct on the Visual Paired Associates Task | Week 6 | 0.60 proportion of image pairs |
| Waitlist Control | Change in Cognitive Performance, as Measured by Percent Correct on the Visual Paired Associates Task | Baseline | 0.56 proportion of image pairs |
| Waitlist Control | Change in Cognitive Performance, as Measured by Percent Correct on the Visual Paired Associates Task | Week 6 | 0.67 proportion of image pairs |
Comparison: Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control.p-value: 0.06Mixed Models Analysis
Secondary
Change in Cognitive Performance, as Measured by Proportion Correct on the Letter-Number Switching Test
This task measures sustained attention and set-shifting, and requires participants to switch between responses to letters and numbers. The outcome measure is proportion of correct switch trials, indicating that participants successfully switched from a letter response to a number response, or vice versa (on a scale of 0 to 1, with 0 being no correct switches and 1 being correct switches on all switch trials). Higher proportion correct for switch trials indicates better set-shifting performance, while lower proportion correct indicates worse set-shifting performance.
Time frame: Baseline and Post Treatment (6 weeks)
Population: Analysis of outcome measure excludes participants who did not complete this task / timepoint and performance-based outliers.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| AKL-T01 Intervention | Change in Cognitive Performance, as Measured by Proportion Correct on the Letter-Number Switching Test | Baseline | 0.93 proportion of correct switch trials |
| AKL-T01 Intervention | Change in Cognitive Performance, as Measured by Proportion Correct on the Letter-Number Switching Test | Week 6 | 0.98 proportion of correct switch trials |
| Waitlist Control | Change in Cognitive Performance, as Measured by Proportion Correct on the Letter-Number Switching Test | Baseline | 0.95 proportion of correct switch trials |
| Waitlist Control | Change in Cognitive Performance, as Measured by Proportion Correct on the Letter-Number Switching Test | Week 6 | 0.96 proportion of correct switch trials |
Comparison: Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control.p-value: 0.04Mixed Models Analysis
Secondary
Change in Cognitive Performance, as Measured by Proportion Correct on the Multiple Object Tracking Test
Change in scores on the Multiple Object Tracking task in the experimental group vs. controls This task measures sustained attention, cognitive control, and working memory, and requires participants to remember and track a set of target circles as they move around the screen, among a larger set of identical distractor circles. The outcome measure is the proportion of dots that a participant was able to track and identify successfully (on a scale of 0 to 1, with 0 being no dots and 1 being all of the dots). Higher proportion reflects better performance, while lower proportions reflect poorer task performance.
Time frame: Baseline and Post Treatment (6 weeks)
Population: Analysis of outcome measure excludes participants who did not complete this task / timepoint and performance-based outliers.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| AKL-T01 Intervention | Change in Cognitive Performance, as Measured by Proportion Correct on the Multiple Object Tracking Test | Baseline | 0.72 proportion of dots tracked |
| AKL-T01 Intervention | Change in Cognitive Performance, as Measured by Proportion Correct on the Multiple Object Tracking Test | Week 6 | 0.78 proportion of dots tracked |
| Waitlist Control | Change in Cognitive Performance, as Measured by Proportion Correct on the Multiple Object Tracking Test | Baseline | 0.73 proportion of dots tracked |
| Waitlist Control | Change in Cognitive Performance, as Measured by Proportion Correct on the Multiple Object Tracking Test | Week 6 | 0.76 proportion of dots tracked |
Comparison: Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control.p-value: 0.79Mixed Models Analysis
Secondary
Change in Cognitive Performance, as Measured by the Choice Reaction Time Test
Change in scores on the Choice Reaction Time task in the experimental group vs. controls This task measures processing speed and cognitive control, and requires participants to indicate the direction of an arrow that is a different color from the rest. Faster response times indicate better performance than slower response times.
Time frame: Baseline and Post Treatment (6 weeks)
Population: Analysis of outcome measure excludes participants who did not complete this task / timepoint and performance-based outliers.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| AKL-T01 Intervention | Change in Cognitive Performance, as Measured by the Choice Reaction Time Test | Baseline | 1183 millisecond |
| AKL-T01 Intervention | Change in Cognitive Performance, as Measured by the Choice Reaction Time Test | Week 6 | 1062 millisecond |
| Waitlist Control | Change in Cognitive Performance, as Measured by the Choice Reaction Time Test | Baseline | 1164 millisecond |
| Waitlist Control | Change in Cognitive Performance, as Measured by the Choice Reaction Time Test | Week 6 | 1028 millisecond |
Comparison: Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control.p-value: 0.96Mixed Models Analysis
Secondary
Change in Cognitive Performance, as Measured by the Simple Reaction Time Test
Change in scores on the Simple Reaction Time task in the experimental group vs. controls This task measures simple reaction time and psychomotor speed, and requires participants to press a key whenever a green square appears. Faster response times indicate better performance than slower response times.
Time frame: Baseline and Post Treatment (6 weeks)
Population: Analysis of outcome measure excludes participants who did not complete this task / timepoint and performance-based outliers.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| AKL-T01 Intervention | Change in Cognitive Performance, as Measured by the Simple Reaction Time Test | Baseline | 450 millisecond |
| AKL-T01 Intervention | Change in Cognitive Performance, as Measured by the Simple Reaction Time Test | Week 6 | 375 millisecond |
| Waitlist Control | Change in Cognitive Performance, as Measured by the Simple Reaction Time Test | Baseline | 434 millisecond |
| Waitlist Control | Change in Cognitive Performance, as Measured by the Simple Reaction Time Test | Week 6 | 411 millisecond |
Comparison: Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control.p-value: 0.02Mixed Models Analysis
Secondary
Change in Daily Functioning, as Measured by the NeuroQOL Cognitive Function Scale
Change in scores on the NeuroQOL Cognitive Function scale in the experimental group vs. controls. The NeuroQOL Cognitive Function scale is a 28-item self-report measure of daily functioning. Higher scores, defined as those exceeding the population mean (mean (SD) = 50.09 (10.23)), reflect better self-reported daily cognitive abilities, while lower scores, defined as those falling below the population mean, reflect poorer self-reported daily cognitive abilities.
Time frame: Baseline and Post Treatment (6 weeks)
Population: Analysis of outcome measure excludes participants who did not complete this scale / timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| AKL-T01 Intervention | Change in Daily Functioning, as Measured by the NeuroQOL Cognitive Function Scale | Baseline | 25.4 score on a scale |
| AKL-T01 Intervention | Change in Daily Functioning, as Measured by the NeuroQOL Cognitive Function Scale | Week 6 | 30.2 score on a scale |
| Waitlist Control | Change in Daily Functioning, as Measured by the NeuroQOL Cognitive Function Scale | Week 6 | 28.6 score on a scale |
| Waitlist Control | Change in Daily Functioning, as Measured by the NeuroQOL Cognitive Function Scale | Baseline | 25.7 score on a scale |
Comparison: Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.p-value: 0.04Mixed Models Analysis
Secondary
Change in Overall Daily Functioning, as Measured by the World Health Organization Disability Assessment Scale (WHODAS) 2.0
Change in total score on the 36-item WHODAS in the experimental group vs. controls. The WHODAS 2.0 assesses the following domains of functioning: cognition, mobility, getting along, self-care, participation, and life activities. Scores range from 0 (no disability) to 100 (maximum disability), with higher scores reflecting a greater degree of overall functional disability.
Time frame: Baseline and Post Treatment (6 weeks)
Population: Analysis of outcome measure excludes participants who did not complete this scale / timepoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| AKL-T01 Intervention | Change in Overall Daily Functioning, as Measured by the World Health Organization Disability Assessment Scale (WHODAS) 2.0 | Baseline | 70.4 score on a scale |
| AKL-T01 Intervention | Change in Overall Daily Functioning, as Measured by the World Health Organization Disability Assessment Scale (WHODAS) 2.0 | Week 6 | 60.4 score on a scale |
| Waitlist Control | Change in Overall Daily Functioning, as Measured by the World Health Organization Disability Assessment Scale (WHODAS) 2.0 | Baseline | 69.8 score on a scale |
| Waitlist Control | Change in Overall Daily Functioning, as Measured by the World Health Organization Disability Assessment Scale (WHODAS) 2.0 | Week 6 | 66.1 score on a scale |
Comparison: Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control.p-value: 0.04Mixed Models Analysis