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This study assess the effectiveness of novel cognitive intervention utilizing tablet apps (TECH protocol: Tablet Enhancement of Cognition and Health) to improve cognitive abilities, daily function and health-related quality of life of older adults with MCI. Older adults with MCI will be randomly allocated to the TECH protocol (experimental group) or standard care (control group). Assessments will be administered pre and post the 6-week TECH protocol and at 6-month follow-up by assessors blind to group allocation.
A single-blind randomized controlled trial (RCT) will be conducted, by assessors blind to group allocation. Participants will be referred to the study from 'Maccabi Healthcare Services' by family physicians and geriatric physician of 'Maccabi Healthcare Services Central District'. The majority of TECH protocol training will take place in the participants' home as self-practice. The assessment and weekly group meetings will take place at clinics of Maccabi Healthcare Services in the Central District. A Helsinki approval (#2016009) has already been obtained. Participants will receive information regarding the study and if eligible will sign a consent form, undergo the screening and then the pre-intervention assessments. Then they will be randomly allocated into experimental or control group by a computer program (stratification of the severity of the cognitive decline according to the Montreal Cognitive Assessment (MoCA) scores of above or below 23 points). The experimental group participants will receive the TECH protocol, while participants in the control group will continue to receive standard care. Following the intervention a second assessment will be performed, as well as six-months follow-up assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TECH protocol | Experimental | TECH protocol - Daily self-training using tablet apps facilitated by weekly group sessions. The self-training will take place independently at participants' home and will include mostly playing puzzle-apps to train different cognitive components. Participants will be requested to play (and log) various apps three to five times a week for 30-60 minutes each time, for a total of 15-25 training sessions. In addition they will use the tablets for a variety of everyday uses. The individual self-training will be accompanied by six weekly sessions (of 60 minutes) in a small group setting (5-6 participants) led by an experienced occupational therapist. |
|
| standard care or active standard care | Active Comparator | Participants will receive standard occupational therapy with no TECH protocol. or Will receive active standard care: six weekly group sessions (60 minutes) for cognitive training using puzzle games. The setting will includes small groups of 5-6 participants, with no self training at home. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TECH: Tablet Enhancement of Cognition and Health protocol | Other | Cognitive training using touchscreen tablets (TECH protocol) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Montreal Cognitive Assessment (MoCA) | A cognitive screening tool that assesses global cognition and includes the cognitive components: attention and concentration, executive functions, memory, language, visuo-constructional skills, conceptual thinking, calculations, and orientation. Total score range from 0-30. A higher score indicates a better cognitive status. A score above 26 indicates normal cognition | pre intervention, post 5 weeks intervention, follow-up after 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| WebNeuro | A computerized web-based battery assessment of neurocognitive functioning. The battery will include seven subtests that examine three cognitive domains: memory (Memory recognition/verbal list-learning task), executive planning (Switching of attention test, Verbal interference test, Maze test, Go-no-go test), and attention (Digit span test, Continuous performance test). A total thinking score will be calculated. Z score was calculated, providing a uniform comparison of the raw scores to a normative database, regardless of the original unit of measure used. The Z scores have a normative average of 0, with a standard deviation of 1, and no upper of lower limit. Positive values reflect better than average performance, and negative values reflect poorer than average performance. |
| Measure | Description | Time Frame |
|---|---|---|
| The Geriatric Depression Scale (GDS) | Valid and reliable self-rating screening tool developed to detect depressive symptoms in elderly (D'ath, Katona, Mullan, Evans, & Katona, 1994; Lesher & Berryhill, 1994). The questionnaire includes 15 yes/no statements and takes up to10 minutes to complete. Total score ranges from 0-15. A higher score indicates a worse emotional state. Score above 10 points indicates the presence of depressive symptoms (Yesavage et al., 1983). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zvi Buckman, MD | Maccabi Healthcare Services, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maccabi Healthcare Services | Tel Aviv | Israel |
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| ID | Title | Description |
|---|---|---|
| FG000 | TECH Protocol | TECH protocol - Daily self-training using tablet apps facilitated by weekly group sessions. The self-training will take place independently at participants' home and will include mostly playing puzzle-apps to train different cognitive components. Participants will be requested to play (and log) various apps three to five times a week for 30-60 minutes each time, for a total of 15-25 training sessions. In addition they will use the tablets for a variety of everyday uses. The individual self-training will be accompanied by six weekly sessions (of 60 minutes) in a small group setting (5-6 participants) led by an experienced occupational therapist. TECH: Tablet Enhancement of Cognition and Health protocol: Cognitive training using touchscreen tablets (TECH protocol) |
| FG001 | Standard Care or Active Standard Care | Participants will receive standard occupational therapy with no TECH protocol. or Will receive active standard care: six weekly group sessions (60 minutes) for cognitive training using puzzle games. The setting will includes small groups of 5-6 participants, with no self training at home. Standard care or active standard care: standard occupational therapy or 6-weekly group sessions playing board games and puzzles. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-Post Intervention |
|
| ||||||||||||||||||
| Post to Follow-up |
|
According to the inclusion criteria, all participants had MCI, were independent in BADL and IADL without severe depressive symptoms. Most participants reported to use a smartphone or/and a computer on a daily basis prior to the study, a few reported previous touchscreen tablet experience.
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| ID | Title | Description |
|---|---|---|
| BG000 | TECH Protocol | TECH protocol - Daily self-training using tablet apps facilitated by weekly group sessions. The self-training will take place independently at participants' home and will include mostly playing puzzle-apps to train different cognitive components. Participants will be requested to play (and log) various apps three to five times a week for 30-60 minutes each time, for a total of 15-25 training sessions. In addition they will use the tablets for a variety of everyday uses. The individual self-training will be accompanied by six weekly sessions (of 60 minutes) in a small group setting (5-6 participants) led by an experienced occupational therapist. TECH: Tablet Enhancement of Cognition and Health protocol: Cognitive training using touchscreen tablets (TECH protocol) |
| 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 | The Montreal Cognitive Assessment (MoCA) | A cognitive screening tool that assesses global cognition and includes the cognitive components: attention and concentration, executive functions, memory, language, visuo-constructional skills, conceptual thinking, calculations, and orientation. Total score range from 0-30. A higher score indicates a better cognitive status. A score above 26 indicates normal cognition | Posted | Mean | Standard Deviation | units on a scale | pre intervention, post 5 weeks intervention, follow-up after 6 months |
|
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 | TECH Protocol | TECH protocol - Daily self-training using tablet apps facilitated by weekly group sessions. The self-training will take place independently at participants' home and will include mostly playing puzzle-apps to train different cognitive components. Participants will be requested to play (and log) various apps three to five times a week for 30-60 minutes each time, for a total of 15-25 training sessions. In addition they will use the tablets for a variety of everyday uses. The individual self-training will be accompanied by six weekly sessions (of 60 minutes) in a small group setting (5-6 participants) led by an experienced occupational therapist. TECH: Tablet Enhancement of Cognition and Health protocol: Cognitive training using touchscreen tablets (TECH protocol) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Zvi Buckman | Assuta Hospital Systems | +97237462520 | Bukman_tz@mac.org.il |
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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 | Mar 1, 2020 | Sep 12, 2021 | Prot_SAP_000.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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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Assessors were blind to group allocation.
| Standard care or active standard care | Other | standard occupational therapy or 6-weekly group sessions playing board games and puzzles. |
|
| pre intervention, post 5 weeks intervention, follow-up after 6 months |
| General Self-Efficacy Scale | Designed to assess optimistic self-beliefs to cope with a variety of difficult demands in life. It consists 10 statements such as 'I can solve most problems if I invest the necessary effort'. Possible responses are scored 1-4 (1 - not at all true to 4 - exactly true), the total score range from 10 to 40. Higher scores represent higher levels of general selfefficacy. | pre intervention, post 5 weeks intervention, follow-up after 6 months |
| The 12-Item Short Form Health Survey (SF-12) | SF-12 includes 12 questions from the SF-36 Health Survey. The SF-36 is a widely used and investigated, and validated instrument for measuring quality of life. The SF-12 was developed using normative data for the SF-36 in the United States. The shorter version designed to reproduce the Physical and the Mental Components Summary scores. A greater score indicates better health measures. The Physical Composite and Mental Composite will be calculated. Scores range from 0 to 100 for each subscale, with higher scores indicating better physical and mental health functioning | pre intervention, post 5 weeks intervention, follow-up after 6 months |
| Pre intervention |
| Structural and Functional Magnetic Resonance Imaging (MRI) | Changes in brain volume, activity, and white-matter integrity will be assessed by MRI whole brain scanning. MRI scans will be performed on a 3T Prisma Siemens scanner at the Alfredo Federico Strauss Center for Computational Neuroimaging at Tel Aviv University. The MRI scans will include: two short structural assessments - magnetization prepared - rapid gradient echo (MP-RAGE) and fluid-attenuated inversion recovery (FLAIR) - diffusion tensor imaging (DTI) and functional magnetic resonance imaging (f-MRI) (while participants perform the N-back test). 12 Participants allocated to the TECH intervention (experimental group) will be offered to undergo pre and post MRI scans. | pre, post |
| The Tower of Hanoi (ToH) Task - Nomber of Moves | A commonly used goal-directed measure assessing problem-solving, and specifically, planning. A computerized version of the task was used (http://vornlocher.de/tower).The participants completed the first two (out of six) levels of the task. the number of moves per level were recorded. less moves considered better. | pre intervention, post 5 weeks intervention, follow-up after 6 months |
| The Tower of Hanoi (ToH) Task- Complition Time | A commonly used goal-directed measure assessing problem-solving, and specifically, planning. A computerized version of the task was used (http://vornlocher.de/tower).The participants completed the first two (out of six) levels of the task. the time for completion (seconds) were recorded. Shorter time for completetion considered better. | pre intervention, post 5 weeks intervention, follow-up after 6 months |
| NOT COMPLETED |
|
|
| BG001 | Standard Care or Active Standard Care | Participants will receive standard occupational therapy with no TECH protocol. or Will receive active standard care: six weekly group sessions (60 minutes) for cognitive training using puzzle games. The setting will includes small groups of 5-6 participants, with no self training at home. Standard care or active standard care: standard occupational therapy or 6-weekly group sessions playing board games and puzzles. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Montreal Cognitive Assessment (MoCA) | This is a cognitive screening tool that assesses global cognition and includes the cognitive components: attention and concentration, executive functions, memory, language, visuo-constructional skills, conceptual thinking, calculations, and orientation. scores range from 0-30. A higher score indicates a better cognitive status. A score above 26 indicates normal cognition | Mean | Standard Deviation | units on a scale |
|
| OG001 | Standard Care or Active Standard Care | Participants will receive standard occupational therapy with no TECH protocol. or Will receive active standard care: six weekly group sessions (60 minutes) for cognitive training using puzzle games. The setting will includes small groups of 5-6 participants, with no self training at home. Standard care or active standard care: standard occupational therapy or 6-weekly group sessions playing board games and puzzles. |
|
|
| Secondary | WebNeuro | A computerized web-based battery assessment of neurocognitive functioning. The battery will include seven subtests that examine three cognitive domains: memory (Memory recognition/verbal list-learning task), executive planning (Switching of attention test, Verbal interference test, Maze test, Go-no-go test), and attention (Digit span test, Continuous performance test). A total thinking score will be calculated. Z score was calculated, providing a uniform comparison of the raw scores to a normative database, regardless of the original unit of measure used. The Z scores have a normative average of 0, with a standard deviation of 1, and no upper of lower limit. Positive values reflect better than average performance, and negative values reflect poorer than average performance. | Posted | Median | Inter-Quartile Range | z-score | pre intervention, post 5 weeks intervention, follow-up after 6 months |
|
|
|
| Secondary | General Self-Efficacy Scale | Designed to assess optimistic self-beliefs to cope with a variety of difficult demands in life. It consists 10 statements such as 'I can solve most problems if I invest the necessary effort'. Possible responses are scored 1-4 (1 - not at all true to 4 - exactly true), the total score range from 10 to 40. Higher scores represent higher levels of general selfefficacy. | Posted | Median | Inter-Quartile Range | units on a scale | pre intervention, post 5 weeks intervention, follow-up after 6 months |
|
|
|
| Secondary | The 12-Item Short Form Health Survey (SF-12) | SF-12 includes 12 questions from the SF-36 Health Survey. The SF-36 is a widely used and investigated, and validated instrument for measuring quality of life. The SF-12 was developed using normative data for the SF-36 in the United States. The shorter version designed to reproduce the Physical and the Mental Components Summary scores. A greater score indicates better health measures. The Physical Composite and Mental Composite will be calculated. Scores range from 0 to 100 for each subscale, with higher scores indicating better physical and mental health functioning | Posted | Median | Inter-Quartile Range | units on a scale | pre intervention, post 5 weeks intervention, follow-up after 6 months |
|
|
|
| Other Pre-specified | The Geriatric Depression Scale (GDS) | Valid and reliable self-rating screening tool developed to detect depressive symptoms in elderly (D'ath, Katona, Mullan, Evans, & Katona, 1994; Lesher & Berryhill, 1994). The questionnaire includes 15 yes/no statements and takes up to10 minutes to complete. Total score ranges from 0-15. A higher score indicates a worse emotional state. Score above 10 points indicates the presence of depressive symptoms (Yesavage et al., 1983). | Posted | Mean | Standard Deviation | units on a scale | Pre intervention |
|
|
|
| Other Pre-specified | Structural and Functional Magnetic Resonance Imaging (MRI) | Changes in brain volume, activity, and white-matter integrity will be assessed by MRI whole brain scanning. MRI scans will be performed on a 3T Prisma Siemens scanner at the Alfredo Federico Strauss Center for Computational Neuroimaging at Tel Aviv University. The MRI scans will include: two short structural assessments - magnetization prepared - rapid gradient echo (MP-RAGE) and fluid-attenuated inversion recovery (FLAIR) - diffusion tensor imaging (DTI) and functional magnetic resonance imaging (f-MRI) (while participants perform the N-back test). 12 Participants allocated to the TECH intervention (experimental group) will be offered to undergo pre and post MRI scans. | Not Posted | pre, post | Participants |
| Other Pre-specified | The Tower of Hanoi (ToH) Task - Nomber of Moves | A commonly used goal-directed measure assessing problem-solving, and specifically, planning. A computerized version of the task was used (http://vornlocher.de/tower).The participants completed the first two (out of six) levels of the task. the number of moves per level were recorded. less moves considered better. | Posted | Mean | Standard Deviation | Nomber of moves | pre intervention, post 5 weeks intervention, follow-up after 6 months |
|
|
|
| Other Pre-specified | The Tower of Hanoi (ToH) Task- Complition Time | A commonly used goal-directed measure assessing problem-solving, and specifically, planning. A computerized version of the task was used (http://vornlocher.de/tower).The participants completed the first two (out of six) levels of the task. the time for completion (seconds) were recorded. Shorter time for completetion considered better. | Posted | Mean | Standard Deviation | Seconds | pre intervention, post 5 weeks intervention, follow-up after 6 months |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Standard Care or Active Standard Care | Participants will receive standard occupational therapy with no TECH protocol. or Will receive active standard care: six weekly group sessions (60 minutes) for cognitive training using puzzle games. The setting will includes small groups of 5-6 participants, with no self training at home. Standard care or active standard care: standard occupational therapy or 6-weekly group sessions playing board games and puzzles. | 0 | 31 | 0 | 31 | 0 | 31 |
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| Follow up after 6 months |
|
| Follow up after 6 months |
|
| Physical Composite Follow up after 6 months |
|
| Mental Composite Pre intervention |
|
| Mental Composite Post 5 weeks intervention |
|
| Mental Composite Follow up after 6 months |
|
| level 1 moves follow-up |
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| level 2 moves pre |
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| level 2 moves post |
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| level 2 moves follow up |
|
| level 1 completion time follow up |
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| level 2 completion time pre |
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| level 2 completion time post |
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| level 2 completion time follow up |
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