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| Name | Class |
|---|---|
| Akili Interactive Labs, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AKL-T01 Intervention | Experimental | 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. |
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| Waitlist Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AKL-T01 | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Post Treatment (6 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Faith Gunning, PhD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | New York | New York | 10065 | United States |
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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 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | Control Arm Participants Who Started AKL-T01 Intervention | Participants who opted to start the intervention after the waitlist control period. |
| FG003 | Control Arm Participants Who Declined AKL-T01 Intervention | Participants who opted to not start the intervention after the waitlist control period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
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| Week 6 Assessment |
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| Week 10 Follow-Up |
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| Week 16 Follow-Up |
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Baseline analysis includes the sample who initiated the trial and were included in the final analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Analysis of outcome measure excludes participants who did not complete this task / timepoint and performance-based outliers. | Posted | Least Squares Mean | 95% Confidence Interval | number of correct matches | Baseline and Post Treatment (6 weeks) |
|
Adverse event data were collected in all participants for the duration of enrollment. Adverse event data were collected for 10 weeks in: participants in the intervention arm and participants in the waitlist control arm, including control participants who did not start the intervention. Adverse event data were collected for 6 additional weeks (16 weeks total) in: control participants who started the intervention after the waitlist control arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | Non-systematic Assessment | Participants experienced dizziness during gameplay, particularly during fast racing sessions. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lindsay Victoria, PhD | Weill Cornell Medicine | 646-962-3973 | liv3002@med.cornell.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 18, 2022 | Dec 13, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D011024 | Pneumonia, Viral |
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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.
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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.
| Baseline and Post Treatment (6 weeks) |
| 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. | Baseline and Post Treatment (6 weeks) |
| 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. | Baseline and Post Treatment (6 weeks) |
| 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. | Baseline and Post Treatment (6 weeks) |
| 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. | Baseline and Post Treatment (6 weeks) |
| 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. | Baseline and Post Treatment (6 weeks) |
| 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. | Baseline and Post Treatment (6 weeks) |
| 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. | Baseline and Post Treatment (6 weeks) |
| 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. | Baseline and Post Treatment (6 weeks) |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Education | Mean | Standard Deviation | years |
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| COVID Treatment Category | Count of Participants | Participants |
|
| Oral Trails A | Assessment of executive function / sequential set shifting. Participants are instructed to count verbally from 1 to 25; the time to complete the count is recorded in seconds. Longer times indicate more executive dysfunction. | Mean | Standard Deviation | seconds |
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| Oral Trails B | Assessment of executive function / sequential set shifting. Participants are instructed to count verbally from 1 to 13, alternating a number and a letter (e.g., 1-A-2-B-3-C, etc.); the time to complete the count is recorded in seconds. Longer times indicate more executive dysfunction. | Mean | Standard Deviation | seconds |
|
| Stroop Color-Word t-score | Stroop Task interference for incongruent color/word stimuli. Participants read color-word stimuli aloud for 45 seconds, score represents number of words read. Reported t-scores are corrected for age and education. Greater scores indicate less executive dysfunction. A t-score of 50 represents the population mean (with a standard deviation of 10). A t-score of 40 reflects performance one standard deviation below age- and education-adjusted norms (16th percentile). Participants that performed > or equal to one standard deviation below adjusted means were considered for inclusion in the trial. | Mean | Standard Deviation | t-score |
|
| FrSBe Total Score (before COVID) | Frontal Systems Behavior Scale, a self-report measure of apathy, disinhibition, and executive dysfunction. Scored on a scale from 46-230; higher score indicate more dysfunction. | Mean | Standard Deviation | score on a scale |
|
| FrSBe Total Score (after COVID) | Frontal Systems Behavior Scale, a self-report measure of apathy, disinhibition, and executive dysfunction. Scored on a scale from 46-230; higher score indicate more dysfunction. | Mean | Standard Deviation | score on a scale |
|
| OG001 | 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. |
|
|
|
| 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. | Analysis of outcome measure excludes participants who did not complete this scale / timepoint. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline and Post Treatment (6 weeks) |
|
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| 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. | Analysis of outcome measure excludes participants who did not complete this task / timepoint and performance-based outliers. | Posted | Least Squares Mean | 95% Confidence Interval | proportion of dots tracked | Baseline and Post Treatment (6 weeks) |
|
|
|
|
| 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. | Analysis of outcome measure excludes participants who did not complete this task / timepoint and performance-based outliers. | Posted | Least Squares Mean | 95% Confidence Interval | digit span | Baseline and Post Treatment (6 weeks) |
|
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|
|
| 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. | Analysis of outcome measure excludes participants who did not complete this task / timepoint and performance-based outliers. | Posted | Least Squares Mean | 95% Confidence Interval | millisecond | Baseline and Post Treatment (6 weeks) |
|
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|
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| 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. | Analysis of outcome measure excludes participants who did not complete this task / timepoint and performance-based outliers. | Posted | Least Squares Mean | 95% Confidence Interval | millisecond | Baseline and Post Treatment (6 weeks) |
|
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| 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. | Analysis of outcome measure excludes participants who did not complete this task / timepoint and performance-based outliers. | Posted | Least Squares Mean | 95% Confidence Interval | proportion of correct switch trials | Baseline and Post Treatment (6 weeks) |
|
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| 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. | Analysis of outcome measure excludes participants who did not complete this task / timepoint and performance-based outliers. | Posted | Least Squares Mean | 95% Confidence Interval | d-prime | Baseline and Post Treatment (6 weeks) |
|
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| 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. | Analysis of outcome measure excludes participants who did not complete this task / timepoint and performance-based outliers. | Posted | Least Squares Mean | 95% Confidence Interval | proportion of image pairs | Baseline and Post Treatment (6 weeks) |
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| 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. | Analysis of outcome measure excludes participants who did not complete this scale / timepoint. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline and Post Treatment (6 weeks) |
|
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| 0 |
| 55 |
| 0 |
| 55 |
| 5 |
| 55 |
| EG001 | 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. | 0 | 55 | 0 | 55 | 2 | 55 |
| EG002 | Control Arm Participants Who Started AKL-T01 Intervention | Participants who opted to start the intervention after the waitlist control period. | 0 | 46 | 0 | 46 | 2 | 46 |
| EG003 | Control Arm Participants Who Declined AKL-T01 Intervention | Participants who opted to not start the intervention after the waitlist control period. | 0 | 2 | 0 | 2 | 0 | 2 |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment | Participant experienced nausea the seven times she played the game - reported feeling nauseous in the middle of each daily session. |
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| Headache | Nervous system disorders | Non-systematic Assessment | Daily game session triggered headaches due to cognitive exertion / visual tracking. |
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| Visual symptoms | Eye disorders | Non-systematic Assessment | Participant had difficulty with visual sensations following gameplay. |
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| Planned surgery | Gastrointestinal disorders | Non-systematic Assessment | Participant had planned gastrointestinal surgery during enrollment. Did not impact participation. |
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| Fall | Nervous system disorders | Non-systematic Assessment | Participant fell on ice in the park. No injury or loss of consciousness. |
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| Cancer recurrence | General disorders | Non-systematic Assessment | Participant had a recurrence of cancer during participation and opted to withdraw. |
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| D011014 |
| Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Week 6 |
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| Superiority |
| Week 6 |
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Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).
| Superiority |
| Week 6 |
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Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).
| Superiority |
| Week 6 |
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Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).
| Superiority |
| Week 6 |
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Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).
| Superiority |
| Week 6 |
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Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).
| Superiority |
| Week 6 |
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Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).
| Superiority |
| Week 6 |
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Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).
| Superiority |
| Week 6 |
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Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).
| Superiority |