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| ID | Type | Description | Link |
|---|---|---|---|
| RX003015 | Other Grant/Funding Number | Department of Veterans Affairs |
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This study will examine the feasibility of an at-home cognitive training program that incorporates both memory training and online computerized cognitive training (CCT) software. Data will also be collected to determine if this program improves thinking and memory as well as everyday function. The hypothesis is that memory and cognitive training combined , compared to memory training alone or will lead to greater improvements in cognitive performance and daily function.
The objective of this study is to examine feasibility of an at-home cognitive rehabilitation program that incorporates both prospective implementation intentions strategies (PRIIS) and an existing web-based executive function (EF) computerized cognitive training (CCT) software for Veterans with Parkinson's disease (PD) and to collect pilot data to determine the impact of this program on cognition and everyday function. The central hypothesis is that CCT+PRIIS, compared to CCT alone and an active control group, will lead to greater improvements in cognitive performance and daily function. This innovative study uses a set of on-line training games that target aspects of EF susceptible in PD and trains the transfer of cognitive benefits to everyday function, using PRIIS, for Veterans with PD and mild cognitive impairment in executive function. Additionally, training is conducted at home allowing for convenience and flexibility for participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cognitive and memory strategy training | Experimental | The cognitive training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. For memory strategy training, strategies will be performed daily; this will take only a few minutes a day to accomplish. |
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| cognitive and memory strategy control training | Active Comparator | The cognitive training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. For the active control of memory strategy training, strategies will be performed daily; this will take only a few minutes a day to accomplish. |
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| active control for cognitive and memory strategy training | Active Comparator | The cognitive training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. For the active control of memory strategy training, strategies will be performed daily; this will take only a few minutes a day to accomplish. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cognitive training | Behavioral | Cognitive training consists of a set of computerize games played on an iPad at home. Training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in NIH Sponsored Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (NIH-EXAMINER) Executive Composite Score | The NIH-EXAMINER has an established 3-factor model defined by (1) cognitive control, (2) working memory (3) fluency. A confirmatory factor analysis indicates these 3-factors load on to 1-factor: executive composite score. Seven tests in the NIH-EXAMINER is used to compute the composite score. -3 and +3 are the minimum and maximum values. Higher scores indicated better performance. | week 0 (before intervention begins), 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandra L. Kletzel, PhD BA | Edward Hines Jr. VA Hospital, Hines, IL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edward Hines Jr. VA Hospital, Hines, IL | Hines | Illinois | 60141-3030 | United States |
Raw and/or normalized data will be made available in the form of Excel files.
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Final data sets will be made available as per Hines VA Hospital local policy for long term storage and access until enterprise-level resources become available.
These data will be available upon request by researchers and scientists in accordance with federal guidelines and Hines local policy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive and Memory Strategy Training | The cognitive training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. For memory strategy training, strategies will be performed daily; this will take only a few minutes a day to accomplish. cognitive training: Cognitive training consists of a set of computerize games played on an iPad at home. Training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. memory strategy training: the participant's prospective memory strategies will be developed with researchers. Participants will be engage in the strategies daily; this will take only a few minutes a day to accomplish. |
| FG001 | Cognitive and Memory Strategy Control Training | The cognitive training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. For the active control of memory strategy training, strategies will be performed daily; this will take only a few minutes a day to accomplish. cognitive training: Cognitive training consists of a set of computerize games played on an iPad at home. Training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. memory strategy training: the participant's prospective memory strategies will be developed with researchers. Participants will be engage in the strategies daily; this will take only a few minutes a day to accomplish. |
| FG002 | Active Control for Cognitive and Memory Strategy Training | The cognitive training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. For the active control of memory strategy training, strategies will be performed daily; this will take only a few minutes a day to accomplish. active control cognitive training: The active control consists of a set of computerized games played on an iPad. Training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. memory strategy training: the participant's prospective memory strategies will be developed with researchers. Participants will be engage in the strategies daily; this will take only a few minutes a day to accomplish. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive and Memory Strategy Training | The cognitive training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. For memory strategy training, strategies will be performed daily; this will take only a few minutes a day to accomplish. cognitive training: Cognitive training consists of a set of computerize games played on an iPad at home. Training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. memory strategy training: the participant's prospective memory strategies will be developed with researchers. Participants will be engage in the strategies daily; this will take only a few minutes a day to accomplish. |
| 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 | Change in NIH Sponsored Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (NIH-EXAMINER) Executive Composite Score | The NIH-EXAMINER has an established 3-factor model defined by (1) cognitive control, (2) working memory (3) fluency. A confirmatory factor analysis indicates these 3-factors load on to 1-factor: executive composite score. Seven tests in the NIH-EXAMINER is used to compute the composite score. -3 and +3 are the minimum and maximum values. Higher scores indicated better performance. | Only 4 participants completed the intervention and were assessed at endpoint. NIH-EXAMINER is a computerized assessment and must be completed in person. Due to the COVID-19 pandemic, not all assessments could be done in person. Only 2 participants who completed the intervention were able to be assessed with the NIH-EXAMINER in person. No participants randomized to the the Cognitive and Memory Strategy Control Training completed an endpoint NIH-EXAMINER assessment. | Posted | Mean | Standard Error | units on a scale | week 0 (before intervention begins), 8 weeks |
|
6 months
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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 | Cognitive and Memory Strategy Training | The cognitive training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. For memory strategy training, strategies will be performed daily; this will take only a few minutes a day to accomplish. cognitive training: Cognitive training consists of a set of computerize games played on an iPad at home. Training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. memory strategy training: the participant's prospective memory strategies will be developed with researchers. Participants will be engage in the strategies daily; this will take only a few minutes a day to accomplish. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sandra Kletzel | Edward Hines Jr. VA Hospital | 708-202-5735 | sandra.kletzel@va.gov |
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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 24, 2022 | Feb 12, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 10, 2019 | Jan 6, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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randomized control trial. three arms to the study
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| active control cognitive training | Behavioral | The active control consists of a set of computerized games played on an iPad. Training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. |
|
| memory strategy training | Behavioral | the participant's prospective memory strategies will be developed with researchers. Participants will be engage in the strategies daily; this will take only a few minutes a day to accomplish. |
|
| memory strategy training | Behavioral | the participant's prospective memory strategies will be developed with researchers. Participants will be engage in the strategies daily; this will take only a few minutes a day to accomplish. |
|
| BG001 | Cognitive and Memory Strategy Control Training | The cognitive training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. For the active control of memory strategy training, strategies will be performed daily; this will take only a few minutes a day to accomplish. cognitive training: Cognitive training consists of a set of computerize games played on an iPad at home. Training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. memory strategy training: the participant's prospective memory strategies will be developed with researchers. Participants will be engage in the strategies daily; this will take only a few minutes a day to accomplish. |
| BG002 | Active Control for Cognitive and Memory Strategy Training | The cognitive training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. For the active control of memory strategy training, strategies will be performed daily; this will take only a few minutes a day to accomplish. active control cognitive training: The active control consists of a set of computerized games played on an iPad. Training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. memory strategy training: the participant's prospective memory strategies will be developed with researchers. Participants will be engage in the strategies daily; this will take only a few minutes a day to accomplish. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Montreal Cognitive Assessment | Total MoCA score can range from 0-31. Higher scores indicate better global cognitive performance. Scores between 21-25 screen for mild cognitive impairment. | Mean | Full Range | units on a scale |
|
| OG000 | Cognitive and Memory Strategy Training | The cognitive training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. For memory strategy training, strategies will be performed daily; this will take only a few minutes a day to accomplish. cognitive training: Cognitive training consists of a set of computerize games played on an iPad at home. Training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. memory strategy training: the participant's prospective memory strategies will be developed with researchers. Participants will be engage in the strategies daily; this will take only a few minutes a day to accomplish. |
| OG001 | Active Control for Cognitive and Memory Strategy Training | The cognitive training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. For the active control of memory strategy training, strategies will be performed daily; this will take only a few minutes a day to accomplish. active control cognitive training: The active control consists of a set of computerized games played on an iPad. Training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. memory strategy training: the participant's prospective memory strategies will be developed with researchers. Participants will be engage in the strategies daily; this will take only a few minutes a day to accomplish. |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Cognitive and Memory Strategy Control Training | The cognitive training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. For the active control of memory strategy training, strategies will be performed daily; this will take only a few minutes a day to accomplish. cognitive training: Cognitive training consists of a set of computerize games played on an iPad at home. Training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. memory strategy training: the participant's prospective memory strategies will be developed with researchers. Participants will be engage in the strategies daily; this will take only a few minutes a day to accomplish. | 0 | 1 | 0 | 1 | 0 | 1 |
| EG002 | Active Control for Cognitive and Memory Strategy Training | The cognitive training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. For the active control of memory strategy training, strategies will be performed daily; this will take only a few minutes a day to accomplish. active control cognitive training: The active control consists of a set of computerized games played on an iPad. Training will include 4 sessions/week for 8 weeks. Each session will take 30min. Total hours of training is 16 hours. memory strategy training: the participant's prospective memory strategies will be developed with researchers. Participants will be engage in the strategies daily; this will take only a few minutes a day to accomplish. | 0 | 3 | 0 | 3 | 0 | 3 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |