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| ID | Type | Description | Link |
|---|---|---|---|
| R21AG054810 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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Computerized cognitive interventions (CCIs) have been increasingly widely implemented among older adults with mild cognitive impairment (MCI). However, the efficacy of CCIs in maintaining or improving older adults' cognitive and functional health has been modest and highly variable. Older individuals' attitudes toward technology use may help explain some of the variability in CCI effects. The goal of this R21 is to generate proof-of-concept for an intervention that may improve attitudes toward computers among those with MCI, in turn improving engagement with and efficacy of a subsequent CCI. Person-centered care-that is, integrating individuals' preferences throughout the process of intervention--has improved intervention engagement among older persons, including those with MCI. A recent intervention predicated on this person-centered approach is called "personalized engagement program" (PEP). PEP involves a database of individualized computer-led leisure activities. The investigators' recent pilot data in senior living facilities suggest that PEP promotes psychological well-being among older persons with MCI, and may shift computers from dauntingly complex or personally irrelevant devices to familiar, enjoyable technology. These results are consistent with a number of theories indicating that exposure to pleasurable experiences with an object or task improves several dimensions of attitudes, including affective and cognitive components, as well as behavior and motivation. Grounded in both this pilot data and the theory around it, the investigators seek to take the next step in an arc of research ultimately intended to improve the efficacy of CCIs. A small randomized controlled trial (RCT) is proposed to assess whether an initial period of PEP, followed by a standard CCI, improves a) attitudes toward computers, b) engagement with the CCI, and c) cognitive outcomes, compared to an attention control period followed by CCI. Our design involving stratified random assignment of 50 assisted living residents with MCI from 4 senior living facilities to these two groups. The initial phase involves 4 weeks of either attention control or PEP, a "dose" suggested by prior work on attitude change and computers, followed by 6 weeks of CCI for both groups (a period our prior work indicates is sufficient for change in key cognitive domains among this population). This application is the first of which we are aware striving to augment CCIs, which are now ubiquitous, by addressing an attitudinal or affective element of the person, which are often ignored in the cognitive intervention literature. The adjuvant of PEP also answers increasing calls for "personalized" or "person-centered" behavioral interventions with older persons.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEP+CCI | Experimental | PEP: The PEP system is built on a picture-based touch-screen interface on tablet computers. PEP allows users to explore and participate in entertainment, educational, spiritual, and other recreational activities and content personalized according to their interests and preferences. It provides easy access to the Internet and communication applications, and has hundreds of modules spanning music, travel, trivia, games, and religious and inspirational domains. CCI. VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention. Intervention format and fidelity The PEP+CCI group will practice PEP for the first 4 weeks and VSOP for the following 6 weeks. |
|
| control+CCI | Active Comparator | For the control + CCI group, an inert control condition, consisting of nothing outside of the ordinary, will be implemented for the first 4 weeks, and CCI for 6 more weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEP | Behavioral | The PEP system is built on a picture-based touch-screen interface on tablet computers. PEP allows users to explore and participate in entertainment, educational, spiritual, and other recreational activities and content personalized according to their interests and preferences. It provides easy access to the Internet and communication applications, and has hundreds of modules spanning music, travel, trivia, games, and religious and inspirational domains. For instance, if music is among a person's lifelong interests, the system provides access to multiple music genres through jukebox, karaoke and therapeutic music applications that can be tailored to a particular activity and by individual interest (for instance, a preference for classic jazz). As another example, for someone who likes travel or visiting new places, the interface offers access to Google Earth, guided tours, slide shows and regional facts and history. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in ADL Score From Baseline to Week 10 | The Activities of Daily Living (ADL) score is the sum of 15 items, resulting in a total performance score ranging from 0 to 60. Lower scores indicate better self-perceived functioning in daily living activities, while higher scores indicate more impaired functioning. The change score was calculated as Week 10 minus Baseline. | Baseline to Week 10 |
| Mean Change in ADL Score From Baseline to Week 23 | The Activities of Daily Living (ADL) score is the sum of 15 items, creating a total score ranging from 0 to 60. Lower scores indicate better self-perceived functioning in daily living activities, while higher scores indicate more impaired functioning. The change score was calculated as Week 23 minus Baseline. | Baseline to Week 23 |
| Mean Executive Function Measured by Examiner | EXAMINER provides a scoring script that generates an Executive Function (EF) composite by applying item response theory (IRT) Empirical Bayes scoring to the raw continuous task scores. The composite is presented in the original metric used in the item response theory algorithm; the score is not a norm-referenced measure and is not adjusted for age. EF was measured with a subset of five tasks (flanker, set-shifting, dot-counting, category fluency, 1-back and anti-saccades) from the NIH EXAMINER v3.6 battery (Kramer et al., 2014). The composite is presented in the original metric used in the item response theory algorithm; the score is not a norm-referenced measure and is not adjusted for age. Scores range from -1.50 to 1.52. Higher scores mean better executive function. | Baseline to week 4 |
| Mean Executive Function Measured by Examiner | EXAMINER provides a scoring script that generates an Executive Function (EF) composite by applying item response theory (IRT) Empirical Bayes scoring to the raw continuous task scores. The composite is presented in the original metric used in the item response theory algorithm; the score is not a norm-referenced measure and is not adjusted for age. EF was measured with a subset of five tasks (flanker, set-shifting, dot-counting, category fluency, 1-back and anti-saccades) from the NIH EXAMINER v3.6 battery (Kramer et al., 2014). The composite is presented in the original metric used in the item response theory algorithm; the score is not a norm-referenced measure and is not adjusted for age. Scores range from -1.50 to 1.52. Higher scores mean better executive function. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Attitudes Toward Computers Questionnaire | The Attitudes Toward Computers Questionnaire (ATCQ) is a 35-item self-report scale using 5-point Likert responses (1 = strongly disagree to 5 = strongly agree), assessing comfort, efficacy, gender equality, control, interest, dehumanization, and utility. A composite mean score is calculated. Minimum score: 1; Maximum score: 5, Higher scores indicate more positive attitudes toward computers. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Corriveau, PhD | University of Rochester | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brickstone/Saint John Meadow | Rochester | New York | 14618 | United States | ||
| River Edge Manor |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32739240 | Derived | Lin FV, Cottone K, Mcdermott K, Jacobs A, Nelson D, Porsteinsson A, Chapman BP. Attitudes Toward Computers Moderate the Effect of Computerized Cognitive Trainings in Oldest-Old Senior Living Center Residents. Am J Geriatr Psychiatry. 2021 Mar;29(3):285-294. doi: 10.1016/j.jagp.2020.07.001. Epub 2020 Jul 7. |
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83 people were accessed to eligibility; 3 were not interested and 31 did not meet inclusion criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | PEP+CCI | PEP: The PEP system is built on a picture-based touch-screen interface on tablet computers. PEP allows users to explore and participate in entertainment, educational, spiritual, and other recreational activities and content personalized according to their interests and preferences. It provides easy access to the Internet and communication applications, and has hundreds of modules spanning music, travel, trivia, games, and religious and inspirational domains. CCI. VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention. Intervention format and fidelity The PEP+CCI group will practice PEP for the first 4 weeks and VSOP for the following 6 weeks. |
| FG001 | Control+CCI | For the control + CCI group, an inert control condition, consisting of nothing outside of the ordinary, will be implemented for the first 4 weeks, and CCI for 6 more weeks. CCI: VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention. All exercises share visual components and focus on accuracy and fast reaction times. Participants respond either by identifying what object they see or where they see it on the screen. The training will automatically adjust the difficulty of each task based on the participant's performance, ensuring that the participants always operate near their optimal capacity. The training programs will automatically record the percentage of completion of each game and scores. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| End of 4 week evaluation |
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| End of week 10 evaluation |
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| End of 23 weeks |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PEP+CCI | PEP: The PEP system is built on a picture-based touch-screen interface on tablet computers. PEP allows users to explore and participate in entertainment, educational, spiritual, and other recreational activities and content personalized according to their interests and preferences. It provides easy access to the Internet and communication applications, and has hundreds of modules spanning music, travel, trivia, games, and religious and inspirational domains. CCI. VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention. Intervention format and fidelity The PEP+CCI group will practice PEP for the first 4 weeks and VSOP for the following 6 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Mean Change in ADL Score From Baseline to Week 10 | The Activities of Daily Living (ADL) score is the sum of 15 items, resulting in a total performance score ranging from 0 to 60. Lower scores indicate better self-perceived functioning in daily living activities, while higher scores indicate more impaired functioning. The change score was calculated as Week 10 minus Baseline. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 10 |
|
up to 23 weeks
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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 | PEP+CCI | PEP: The PEP system is built on a picture-based touch-screen interface on tablet computers. PEP allows users to explore and participate in entertainment, educational, spiritual, and other recreational activities and content personalized according to their interests and preferences. It provides easy access to the Internet and communication applications, and has hundreds of modules spanning music, travel, trivia, games, and religious and inspirational domains. CCI. VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention. Intervention format and fidelity The PEP+CCI group will practice PEP for the first 4 weeks and VSOP for the following 6 weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vankee Lin | University of Rochester | (585) 276-6002 | vankee_lin@urmc.rochester.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 | Feb 26, 2018 | Sep 28, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 3, 2017 | Sep 28, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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A single-blinded, multi-site (4 SLCs) randomized controlled trial of PEP+CCI, vs. control + CCI is involved. For PEP+CCI group, PEP will be implemented for the first 4 weeks, and CCI for the following 6 weeks. For the control + CCI group, an inert control condition, consisting of nothing outside of the ordinary, will be implemented for the first 4 weeks, and CCI for 6 more weeks. Assessments will be conducted by our research team. Separate staff blind to group assignment will conduct post-training and follow-up assessments. All intervention and assessments will occur in private rooms in relevant SLCs.
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Outcome assessor will be blinded to the group assignment. The participants will be informed to avoid discussing their intervention activities at the post-training and follow up assessments.
|
| CCI | Behavioral | VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention. All exercises share visual components and focus on accuracy and fast reaction times. Participants respond either by identifying what object they see or where they see it on the screen. The training will automatically adjust the difficulty of each task based on the participant's performance, ensuring that the participants always operate near their optimal capacity. The training programs will automatically record the percentage of completion of each game and scores. |
|
| Baseline to End of Week 10 Evaluation |
| Mean Executive Function Measured by Examiner | EXAMINER provides a scoring script that generates an Executive Function (EF) composite by applying item response theory (IRT) Empirical Bayes scoring to the raw continuous task scores. The composite is presented in the original metric used in the item response theory algorithm; the score is not a norm-referenced measure and is not adjusted for age. EF was measured with a subset of five tasks (flanker, set-shifting, dot-counting, category fluency, 1-back and anti-saccades) from the NIH EXAMINER v3.6 battery (Kramer et al., 2014). The composite is presented in the original metric used in the item response theory algorithm; the score is not a norm-referenced measure and is not adjusted for age. Scores range from -1.50 to 1.52. Higher scores mean better executive function. | Baseline to End of 23 Weeks |
| Baseline to week 4 |
| Mean Change in Attitudes Toward Computers Questionnaire | The Attitudes Toward Computers Questionnaire (ATCQ) is a 35-item self-report scale using 5-point Likert responses (1 = strongly disagree to 5 = strongly agree), assessing comfort, efficacy, gender equality, control, interest, dehumanization, and utility. A composite mean score is calculated. Minimum score: 1; Maximum score: 5, Higher scores indicate more positive attitudes toward computers. | Baseline to End of Week 10 Evaluation |
| Mean Change in Attitudes Toward Computers Questionnaire | The Attitudes Toward Computers Questionnaire (ATCQ) is a 35-item self-report scale using 5-point Likert responses (1 = strongly disagree to 5 = strongly agree), assessing comfort, efficacy, gender equality, control, interest, dehumanization, and utility. A composite mean score is calculated. Minimum score: 1; Maximum score: 5, Higher scores indicate more positive attitudes toward computers. | Baseline to End of 23 Weeks |
| Mean Change in Brief Visuospatial Memory Test | The Brief Visuospatial Memory Test-Revised (BVMT-R) delayed recall raw score measures the number of stimuli correctly recalled after a delay. Scores range from 0 to 12, with higher scores indicating better memory performance. Change scores were calculated as Week 4 minus Baseline. | Baseline to Week 4 |
| Mean Change in Brief Visuospatial Memory Test | The BVMT-R delayed recall raw score measures the number of stimuli correctly recalled after a delay. Scores range from 0 to 12, with higher scores indicating better memory performance. Change scores were calculated as Week 10 minus Baseline. | Baseline to Week 10 |
| Mean Change in Brief Visuospatial Memory Test | The BVMT-R delayed recall raw score measures the number of stimuli correctly recalled after a delay. Scores range from 0 to 12, with higher scores indicating better memory performance. Change scores were calculated as Week 23 minus Baseline. | Baseline to week 23 |
| Mean Change in EPCCE Sum Score From Baseline to Week 4 | The Executive Problem-Solving and Cognitive Efficiency (EPCCE) sum score ranges from 0 to 14, with higher scores indicating greater independence and problem-solving ability. Change scores were calculated as Week 4 minus Baseline. | Baseline to Week 4 |
| Mean Change in EPCCE Sum Score From Baseline to Week 10 | The Executive Problem-Solving and Cognitive Efficiency (EPCCE) sum score ranges from 0 to 14, with higher scores indicating greater independence and problem-solving ability. Change scores were calculated as Week 10 minus Baseline. | Baseline to Week 10 |
| Mean Change in EPCCE Sum Score From Baseline to Week 23 | The Executive Problem-Solving and Cognitive Efficiency (EPCCE) sum score ranges from 0 to 14, with higher scores indicating greater independence and problem-solving ability. Change scores were calculated as Week 23 minus Baseline. | Baseline to Week 23 |
| Mean Change in UFOV Score From Baseline to Week 10 | The UFOV score is the mean of three subtests: processing speed, divided attention, and selective attention. Each subtest ranges from 17 to 500 milliseconds. Lower scores indicate faster visual processing and better cognitive performance. Change scores were calculated as Week 10 minus Baseline. | Baseline to Week 10 |
| Mean Change in UFOV Score From Baseline to Week 23 | The UFOV score is the mean of three subtests: processing speed, divided attention, and selective attention. Each subtest ranges from 17 to 500 milliseconds. Lower scores indicate faster visual processing and better cognitive performance. Change scores were calculated as Week 23 minus Baseline. | Baseline to Week 23 |
| Mean Change in Activities of Daily Living-Prevention Instrument | Mean change in self-perceived functioning in daily living activities as measured by the Activities of Daily Living - Prevention Instrument (ADL-PI). The ADL-PI is a sum score of 15 items, with a total score range of 0-60. Higher scores indicate more impaired functioning, while lower scores indicate better functioning. | Baseline to week 23 |
| Rochester |
| New York |
| 14642 |
| United States |
| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | Control+CCI | For the control + CCI group, an inert control condition, consisting of nothing outside of the ordinary, will be implemented for the first 4 weeks, and CCI for 6 more weeks. CCI: VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention. All exercises share visual components and focus on accuracy and fast reaction times. Participants respond either by identifying what object they see or where they see it on the screen. The training will automatically adjust the difficulty of each task based on the participant's performance, ensuring that the participants always operate near their optimal capacity. The training programs will automatically record the percentage of completion of each game and scores. |
| 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 | Count of Participants | Participants |
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| OG001 | Control+CCI | For the control + CCI group, an inert control condition, consisting of nothing outside of the ordinary, will be implemented for the first 4 weeks, and CCI for 6 more weeks. CCI: VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention. All exercises share visual components and focus on accuracy and fast reaction times. Participants respond either by identifying what object they see or where they see it on the screen. The training will automatically adjust the difficulty of each task based on the participant's performance, ensuring that the participants always operate near their optimal capacity. The training programs will automatically record the percentage of completion of each game and scores. |
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| Primary | Mean Change in ADL Score From Baseline to Week 23 | The Activities of Daily Living (ADL) score is the sum of 15 items, creating a total score ranging from 0 to 60. Lower scores indicate better self-perceived functioning in daily living activities, while higher scores indicate more impaired functioning. The change score was calculated as Week 23 minus Baseline. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 23 |
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| Primary | Mean Executive Function Measured by Examiner | EXAMINER provides a scoring script that generates an Executive Function (EF) composite by applying item response theory (IRT) Empirical Bayes scoring to the raw continuous task scores. The composite is presented in the original metric used in the item response theory algorithm; the score is not a norm-referenced measure and is not adjusted for age. EF was measured with a subset of five tasks (flanker, set-shifting, dot-counting, category fluency, 1-back and anti-saccades) from the NIH EXAMINER v3.6 battery (Kramer et al., 2014). The composite is presented in the original metric used in the item response theory algorithm; the score is not a norm-referenced measure and is not adjusted for age. Scores range from -1.50 to 1.52. Higher scores mean better executive function. | Posted | Mean | Standard Deviation | composite raw score (original metric) | Baseline to week 4 |
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| Primary | Mean Executive Function Measured by Examiner | EXAMINER provides a scoring script that generates an Executive Function (EF) composite by applying item response theory (IRT) Empirical Bayes scoring to the raw continuous task scores. The composite is presented in the original metric used in the item response theory algorithm; the score is not a norm-referenced measure and is not adjusted for age. EF was measured with a subset of five tasks (flanker, set-shifting, dot-counting, category fluency, 1-back and anti-saccades) from the NIH EXAMINER v3.6 battery (Kramer et al., 2014). The composite is presented in the original metric used in the item response theory algorithm; the score is not a norm-referenced measure and is not adjusted for age. Scores range from -1.50 to 1.52. Higher scores mean better executive function. | Posted | Mean | Standard Deviation | composite score in the original metric | Baseline to End of Week 10 Evaluation |
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| Primary | Mean Executive Function Measured by Examiner | EXAMINER provides a scoring script that generates an Executive Function (EF) composite by applying item response theory (IRT) Empirical Bayes scoring to the raw continuous task scores. The composite is presented in the original metric used in the item response theory algorithm; the score is not a norm-referenced measure and is not adjusted for age. EF was measured with a subset of five tasks (flanker, set-shifting, dot-counting, category fluency, 1-back and anti-saccades) from the NIH EXAMINER v3.6 battery (Kramer et al., 2014). The composite is presented in the original metric used in the item response theory algorithm; the score is not a norm-referenced measure and is not adjusted for age. Scores range from -1.50 to 1.52. Higher scores mean better executive function. | Posted | Mean | Standard Deviation | composite score in original metric | Baseline to End of 23 Weeks |
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| Secondary | Mean Change in Attitudes Toward Computers Questionnaire | The Attitudes Toward Computers Questionnaire (ATCQ) is a 35-item self-report scale using 5-point Likert responses (1 = strongly disagree to 5 = strongly agree), assessing comfort, efficacy, gender equality, control, interest, dehumanization, and utility. A composite mean score is calculated. Minimum score: 1; Maximum score: 5, Higher scores indicate more positive attitudes toward computers. | Posted | Mean | Standard Deviation | score on a scale | Baseline to week 4 |
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| Secondary | Mean Change in Attitudes Toward Computers Questionnaire | The Attitudes Toward Computers Questionnaire (ATCQ) is a 35-item self-report scale using 5-point Likert responses (1 = strongly disagree to 5 = strongly agree), assessing comfort, efficacy, gender equality, control, interest, dehumanization, and utility. A composite mean score is calculated. Minimum score: 1; Maximum score: 5, Higher scores indicate more positive attitudes toward computers. | Posted | Mean | Standard Deviation | score on a scale | Baseline to End of Week 10 Evaluation |
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| Secondary | Mean Change in Attitudes Toward Computers Questionnaire | The Attitudes Toward Computers Questionnaire (ATCQ) is a 35-item self-report scale using 5-point Likert responses (1 = strongly disagree to 5 = strongly agree), assessing comfort, efficacy, gender equality, control, interest, dehumanization, and utility. A composite mean score is calculated. Minimum score: 1; Maximum score: 5, Higher scores indicate more positive attitudes toward computers. | Posted | Mean | Standard Deviation | score on a scale | Baseline to End of 23 Weeks |
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| Secondary | Mean Change in Brief Visuospatial Memory Test | The Brief Visuospatial Memory Test-Revised (BVMT-R) delayed recall raw score measures the number of stimuli correctly recalled after a delay. Scores range from 0 to 12, with higher scores indicating better memory performance. Change scores were calculated as Week 4 minus Baseline. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 4 |
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| Secondary | Mean Change in Brief Visuospatial Memory Test | The BVMT-R delayed recall raw score measures the number of stimuli correctly recalled after a delay. Scores range from 0 to 12, with higher scores indicating better memory performance. Change scores were calculated as Week 10 minus Baseline. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 10 |
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| Secondary | Mean Change in Brief Visuospatial Memory Test | The BVMT-R delayed recall raw score measures the number of stimuli correctly recalled after a delay. Scores range from 0 to 12, with higher scores indicating better memory performance. Change scores were calculated as Week 23 minus Baseline. | Posted | Mean | Standard Deviation | score on a scale | Baseline to week 23 |
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| Secondary | Mean Change in EPCCE Sum Score From Baseline to Week 4 | The Executive Problem-Solving and Cognitive Efficiency (EPCCE) sum score ranges from 0 to 14, with higher scores indicating greater independence and problem-solving ability. Change scores were calculated as Week 4 minus Baseline. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 4 |
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| Secondary | Mean Change in EPCCE Sum Score From Baseline to Week 10 | The Executive Problem-Solving and Cognitive Efficiency (EPCCE) sum score ranges from 0 to 14, with higher scores indicating greater independence and problem-solving ability. Change scores were calculated as Week 10 minus Baseline. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 10 |
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| Secondary | Mean Change in EPCCE Sum Score From Baseline to Week 23 | The Executive Problem-Solving and Cognitive Efficiency (EPCCE) sum score ranges from 0 to 14, with higher scores indicating greater independence and problem-solving ability. Change scores were calculated as Week 23 minus Baseline. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 23 |
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| Secondary | Mean Change in UFOV Score From Baseline to Week 10 | The UFOV score is the mean of three subtests: processing speed, divided attention, and selective attention. Each subtest ranges from 17 to 500 milliseconds. Lower scores indicate faster visual processing and better cognitive performance. Change scores were calculated as Week 10 minus Baseline. | Posted | Mean | Standard Deviation | milliseconds (ms) | Baseline to Week 10 |
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| Secondary | Mean Change in UFOV Score From Baseline to Week 23 | The UFOV score is the mean of three subtests: processing speed, divided attention, and selective attention. Each subtest ranges from 17 to 500 milliseconds. Lower scores indicate faster visual processing and better cognitive performance. Change scores were calculated as Week 23 minus Baseline. | Posted | Mean | Standard Deviation | milliseconds (ms) | Baseline to Week 23 |
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| Secondary | Mean Change in Activities of Daily Living-Prevention Instrument | Mean change in self-perceived functioning in daily living activities as measured by the Activities of Daily Living - Prevention Instrument (ADL-PI). The ADL-PI is a sum score of 15 items, with a total score range of 0-60. Higher scores indicate more impaired functioning, while lower scores indicate better functioning. | Posted | Mean | Standard Deviation | score on a scale | Baseline to week 23 |
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| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Control+CCI | For the control + CCI group, an inert control condition, consisting of nothing outside of the ordinary, will be implemented for the first 4 weeks, and CCI for 6 more weeks. CCI: VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention. All exercises share visual components and focus on accuracy and fast reaction times. Participants respond either by identifying what object they see or where they see it on the screen. The training will automatically adjust the difficulty of each task based on the participant's performance, ensuring that the participants always operate near their optimal capacity. The training programs will automatically record the percentage of completion of each game and scores. | 1 | 25 | 0 | 25 | 0 | 25 |
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