Trial Outcomes & Findings for Improving Cognitive Health in COVID-19 Survivors (NCT NCT04843930)
NCT ID: NCT04843930
Last Updated: 2024-02-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
110 participants
Primary outcome timeframe
Baseline and Post Treatment (6 weeks)
Results posted on
2024-02-29
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
Control Arm Participants Who Started AKL-T01 Intervention
Participants who opted to start the intervention after the waitlist control period.
|
Control Arm Participants Who Declined AKL-T01 Intervention
Participants who opted to not start the intervention after the waitlist control period.
|
|---|---|---|---|---|
|
Randomization
STARTED
|
55
|
55
|
0
|
0
|
|
Randomization
COMPLETED
|
49
|
49
|
0
|
0
|
|
Randomization
NOT COMPLETED
|
6
|
6
|
0
|
0
|
|
Baseline Assessment
STARTED
|
49
|
49
|
0
|
0
|
|
Baseline Assessment
COMPLETED
|
49
|
49
|
0
|
0
|
|
Baseline Assessment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Week 6 Assessment
STARTED
|
49
|
49
|
0
|
0
|
|
Week 6 Assessment
COMPLETED
|
44
|
48
|
0
|
0
|
|
Week 6 Assessment
NOT COMPLETED
|
5
|
1
|
0
|
0
|
|
Week 10 Follow-Up
STARTED
|
44
|
0
|
0
|
2
|
|
Week 10 Follow-Up
COMPLETED
|
44
|
0
|
0
|
0
|
|
Week 10 Follow-Up
NOT COMPLETED
|
0
|
0
|
0
|
2
|
|
Week 16 Follow-Up
STARTED
|
0
|
0
|
46
|
0
|
|
Week 16 Follow-Up
COMPLETED
|
0
|
0
|
44
|
0
|
|
Week 16 Follow-Up
NOT COMPLETED
|
0
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
Control Arm Participants Who Started AKL-T01 Intervention
Participants who opted to start the intervention after the waitlist control period.
|
Control Arm Participants Who Declined AKL-T01 Intervention
Participants who opted to not start the intervention after the waitlist control period.
|
|---|---|---|---|---|
|
Randomization
Withdrawal by Subject
|
6
|
6
|
0
|
0
|
|
Week 6 Assessment
Adverse Event
|
3
|
0
|
0
|
0
|
|
Week 6 Assessment
Withdrawal by Subject
|
2
|
1
|
0
|
0
|
|
Week 16 Follow-Up
Lost to Follow-up
|
0
|
0
|
2
|
0
|
Baseline Characteristics
Improving Cognitive Health in COVID-19 Survivors
Baseline characteristics by cohort
| Measure |
AKL-T01 Intervention
n=49 Participants
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.
|
Waitlist Control
n=49 Participants
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.
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.5 years
STANDARD_DEVIATION 17.2 • n=5 Participants
|
46.8 years
STANDARD_DEVIATION 16.7 • n=7 Participants
|
48.1 years
STANDARD_DEVIATION 16.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latinx
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More Than One Race
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other / Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
49 participants
n=7 Participants
|
98 participants
n=5 Participants
|
|
Education
|
16.9 years
STANDARD_DEVIATION 2.8 • n=5 Participants
|
16.7 years
STANDARD_DEVIATION 2.2 • n=7 Participants
|
16.8 years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
|
COVID Treatment Category
Outpatient
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
COVID Treatment Category
ER Admission
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
COVID Treatment Category
Inpatient
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
COVID Treatment Category
ICU
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
COVID Treatment Category
No Treatment
|
26 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
COVID Treatment Category
Other
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Oral Trails A
|
8.9 seconds
STANDARD_DEVIATION 2.6 • n=5 Participants
|
8.3 seconds
STANDARD_DEVIATION 2.4 • n=7 Participants
|
8.6 seconds
STANDARD_DEVIATION 2.5 • n=5 Participants
|
|
Oral Trails B
|
32.0 seconds
STANDARD_DEVIATION 15.3 • n=5 Participants
|
32.6 seconds
STANDARD_DEVIATION 16.5 • n=7 Participants
|
32.3 seconds
STANDARD_DEVIATION 15.8 • n=5 Participants
|
|
Stroop Color-Word t-score
|
39.6 t-score
STANDARD_DEVIATION 19.3 • n=5 Participants
|
41.8 t-score
STANDARD_DEVIATION 19.5 • n=7 Participants
|
40.7 t-score
STANDARD_DEVIATION 19.4 • n=5 Participants
|
|
FrSBe Total Score (before COVID)
|
79.5 score on a scale
STANDARD_DEVIATION 17.7 • n=5 Participants
|
80.4 score on a scale
STANDARD_DEVIATION 16.4 • n=7 Participants
|
79.9 score on a scale
STANDARD_DEVIATION 17.0 • n=5 Participants
|
|
FrSBe Total Score (after COVID)
|
111.0 score on a scale
STANDARD_DEVIATION 23.8 • n=5 Participants
|
109.0 score on a scale
STANDARD_DEVIATION 20.8 • n=7 Participants
|
110.0 score on a scale
STANDARD_DEVIATION 22.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Post Treatment (6 weeks)Population: Analysis of outcome measure excludes participants who did not complete this task / timepoint and performance-based outliers.
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.
Outcome measures
| Measure |
AKL-T01 Intervention
n=48 Participants
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.
|
Waitlist Control
n=48 Participants
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.
|
|---|---|---|
|
Change in Cognitive Function, as Measured by Number Correct on the Digit Symbol Matching Task
Baseline
|
63.0 number of correct matches
Interval 61.1 to 65.0
|
63.5 number of correct matches
Interval 61.6 to 65.5
|
|
Change in Cognitive Function, as Measured by Number Correct on the Digit Symbol Matching Task
Week 6
|
67.8 number of correct matches
Interval 65.7 to 69.9
|
69.0 number of correct matches
Interval 67.0 to 70.9
|
SECONDARY outcome
Timeframe: Baseline and Post Treatment (6 weeks)Population: Analysis of outcome measure excludes participants who did not complete this scale / timepoint.
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.
Outcome measures
| Measure |
AKL-T01 Intervention
n=49 Participants
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.
|
Waitlist Control
n=49 Participants
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.
|
|---|---|---|
|
Change in Daily Functioning, as Measured by the NeuroQOL Cognitive Function Scale
Baseline
|
25.4 score on a scale
Interval 24.3 to 26.6
|
25.7 score on a scale
Interval 24.5 to 26.9
|
|
Change in Daily Functioning, as Measured by the NeuroQOL Cognitive Function Scale
Week 6
|
30.2 score on a scale
Interval 29.0 to 31.4
|
28.6 score on a scale
Interval 27.4 to 29.8
|
SECONDARY outcome
Timeframe: Baseline and Post Treatment (6 weeks)Population: Analysis of outcome measure excludes participants who did not complete this task / timepoint and performance-based outliers.
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.
Outcome measures
| Measure |
AKL-T01 Intervention
n=47 Participants
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.
|
Waitlist Control
n=49 Participants
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.
|
|---|---|---|
|
Change in Cognitive Performance, as Measured by Proportion Correct on the Multiple Object Tracking Test
Baseline
|
0.72 proportion of dots tracked
Interval 0.71 to 74.0
|
0.73 proportion of dots tracked
Interval 0.72 to 0.75
|
|
Change in Cognitive Performance, as Measured by Proportion Correct on the Multiple Object Tracking Test
Week 6
|
0.78 proportion of dots tracked
Interval 0.76 to 0.8
|
0.76 proportion of dots tracked
Interval 0.74 to 0.78
|
SECONDARY outcome
Timeframe: Baseline and Post Treatment (6 weeks)Population: Analysis of outcome measure excludes participants who did not complete this task / timepoint and performance-based outliers.
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.
Outcome measures
| Measure |
AKL-T01 Intervention
n=49 Participants
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.
|
Waitlist Control
n=49 Participants
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.
|
|---|---|---|
|
Change in Cognitive Performance, as Measured by Digit Span on the Digit Span Backwards Test
Baseline
|
4.7 digit span
Interval 4.4 to 5.1
|
4.9 digit span
Interval 4.5 to 5.2
|
|
Change in Cognitive Performance, as Measured by Digit Span on the Digit Span Backwards Test
Week 6
|
5.6 digit span
Interval 5.2 to 5.9
|
5.7 digit span
Interval 5.3 to 6.0
|
SECONDARY outcome
Timeframe: Baseline and Post Treatment (6 weeks)Population: Analysis of outcome measure excludes participants who did not complete this task / timepoint and performance-based outliers.
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.
Outcome measures
| Measure |
AKL-T01 Intervention
n=48 Participants
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.
|
Waitlist Control
n=49 Participants
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.
|
|---|---|---|
|
Change in Cognitive Performance, as Measured by the Simple Reaction Time Test
Baseline
|
450 millisecond
Interval 431.0 to 470.0
|
434 millisecond
Interval 414.0 to 453.0
|
|
Change in Cognitive Performance, as Measured by the Simple Reaction Time Test
Week 6
|
375 millisecond
Interval 355.0 to 396.0
|
411 millisecond
Interval 392.0 to 431.0
|
SECONDARY outcome
Timeframe: Baseline and Post Treatment (6 weeks)Population: Analysis of outcome measure excludes participants who did not complete this task / timepoint and performance-based outliers.
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.
Outcome measures
| Measure |
AKL-T01 Intervention
n=46 Participants
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.
|
Waitlist Control
n=48 Participants
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.
|
|---|---|---|
|
Change in Cognitive Performance, as Measured by the Choice Reaction Time Test
Baseline
|
1183 millisecond
Interval 1135.0 to 1230.0
|
1164 millisecond
Interval 1118.0 to 1211.0
|
|
Change in Cognitive Performance, as Measured by the Choice Reaction Time Test
Week 6
|
1062 millisecond
Interval 1013.0 to 1112.0
|
1028 millisecond
Interval 981.0 to 1075.0
|
SECONDARY outcome
Timeframe: Baseline and Post Treatment (6 weeks)Population: Analysis of outcome measure excludes participants who did not complete this task / timepoint and performance-based outliers.
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.
Outcome measures
| Measure |
AKL-T01 Intervention
n=47 Participants
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.
|
Waitlist Control
n=48 Participants
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.
|
|---|---|---|
|
Change in Cognitive Performance, as Measured by Proportion Correct on the Letter-Number Switching Test
Baseline
|
0.93 proportion of correct switch trials
Interval 0.92 to 0.95
|
0.95 proportion of correct switch trials
Interval 0.94 to 0.96
|
|
Change in Cognitive Performance, as Measured by Proportion Correct on the Letter-Number Switching Test
Week 6
|
0.98 proportion of correct switch trials
Interval 0.96 to 0.99
|
0.96 proportion of correct switch trials
Interval 0.94 to 0.97
|
SECONDARY outcome
Timeframe: Baseline and Post Treatment (6 weeks)Population: Analysis of outcome measure excludes participants who did not complete this task / timepoint and performance-based outliers.
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.
Outcome measures
| Measure |
AKL-T01 Intervention
n=48 Participants
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.
|
Waitlist Control
n=49 Participants
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.
|
|---|---|---|
|
Change in Cognitive Performance, as Measured by D-prime on the Gradual Onset Continuous Performance Test
Week 6
|
2.4 d-prime
Interval 2.2 to 2.5
|
2.4 d-prime
Interval 2.2 to 2.5
|
|
Change in Cognitive Performance, as Measured by D-prime on the Gradual Onset Continuous Performance Test
Baseline
|
2.3 d-prime
Interval 2.2 to 2.4
|
2.3 d-prime
Interval 2.1 to 2.4
|
SECONDARY outcome
Timeframe: Baseline and Post Treatment (6 weeks)Population: Analysis of outcome measure excludes participants who did not complete this task / timepoint and performance-based outliers.
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.
Outcome measures
| Measure |
AKL-T01 Intervention
n=48 Participants
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.
|
Waitlist Control
n=49 Participants
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.
|
|---|---|---|
|
Change in Cognitive Performance, as Measured by Percent Correct on the Visual Paired Associates Task
Baseline
|
0.56 proportion of image pairs
Interval 0.52 to 0.59
|
0.56 proportion of image pairs
Interval 0.52 to 0.59
|
|
Change in Cognitive Performance, as Measured by Percent Correct on the Visual Paired Associates Task
Week 6
|
0.60 proportion of image pairs
Interval 0.57 to 0.64
|
0.67 proportion of image pairs
Interval 0.64 to 0.7
|
SECONDARY outcome
Timeframe: Baseline and Post Treatment (6 weeks)Population: Analysis of outcome measure excludes participants who did not complete this scale / timepoint.
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.
Outcome measures
| Measure |
AKL-T01 Intervention
n=44 Participants
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.
|
Waitlist Control
n=48 Participants
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.
|
|---|---|---|
|
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
Interval 67.4 to 73.4
|
69.8 score on a scale
Interval 67.0 to 72.7
|
|
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
Interval 57.3 to 63.5
|
66.1 score on a scale
Interval 63.0 to 69.1
|
Adverse Events
AKL-T01 Intervention
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Waitlist Control
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Control Arm Participants Who Started AKL-T01 Intervention
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Control Arm Participants Who Declined AKL-T01 Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AKL-T01 Intervention
n=55 participants at risk
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.
|
Waitlist Control
n=55 participants at risk
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.
|
Control Arm Participants Who Started AKL-T01 Intervention
n=46 participants at risk
Participants who opted to start the intervention after the waitlist control period.
|
Control Arm Participants Who Declined AKL-T01 Intervention
n=2 participants at risk
Participants who opted to not start the intervention after the waitlist control period.
|
|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
3.6%
2/55 • Number of events 4 • 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.
|
0.00%
0/55 • 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.
|
2.2%
1/46 • Number of events 3 • 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.
|
0.00%
0/2 • 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.
|
|
Gastrointestinal disorders
Nausea
|
1.8%
1/55 • Number of events 7 • 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.
|
0.00%
0/55 • 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.
|
0.00%
0/46 • 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.
|
0.00%
0/2 • 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.
|
|
Nervous system disorders
Headache
|
1.8%
1/55 • Number of events 3 • 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.
|
0.00%
0/55 • 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.
|
0.00%
0/46 • 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.
|
0.00%
0/2 • 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.
|
|
Eye disorders
Visual symptoms
|
0.00%
0/55 • 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.
|
0.00%
0/55 • 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.
|
2.2%
1/46 • Number of events 1 • 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.
|
0.00%
0/2 • 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.
|
|
Gastrointestinal disorders
Planned surgery
|
1.8%
1/55 • Number of events 1 • 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.
|
0.00%
0/55 • 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.
|
0.00%
0/46 • 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.
|
0.00%
0/2 • 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.
|
|
Nervous system disorders
Fall
|
0.00%
0/55 • 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.
|
1.8%
1/55 • Number of events 1 • 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.
|
0.00%
0/46 • 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.
|
0.00%
0/2 • 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.
|
|
General disorders
Cancer recurrence
|
0.00%
0/55 • 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.
|
1.8%
1/55 • Number of events 1 • 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.
|
0.00%
0/46 • 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.
|
0.00%
0/2 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place