An interventional study of TECH: Tablet Enhancement of Cognition and Health protocol and Standard care or active standard care in Mild Cognitive Impairment, sponsored by Assuta Hospital Systems. Completed at 1 site in Israel. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-01.
Sponsored by Assuta Hospital Systems · Not applicable, Interventional, and Treatment
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.
3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.
This study's enrollment of 61 is close to the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Assuta Hospital Systems is the lead sponsor of 34 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: TECH: Tablet Enhancement of Cognition and Health protocol
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.
Other: Standard care or active standard care
Cognitive training using touchscreen tablets (TECH protocol)
standard occupational therapy or 6-weekly group sessions playing board games and puzzles.
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
Time frame: pre intervention, post 5 weeks intervention, follow-up after 6 months
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.
Time frame: 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.
Time frame: 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
Time frame: pre intervention, post 5 weeks intervention, follow-up after 6 months
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: pre intervention, post 5 weeks intervention, follow-up after 6 months
| Milestone | TECH Protocol | Standard Care or Active Standard Care |
|---|---|---|
| Started | 30 | 31 |
| Completed | 25 | 25 |
| Not completed | 5 | 6 |
| Withdrew: Withdrawal by subject | 5 | 6 |
| Milestone | TECH Protocol | Standard Care or Active Standard Care |
|---|---|---|
| Started | 25 | 25 |
| Completed | 17 | 14 |
| Not completed | 8 | 11 |
| Withdrew: Lost to follow-up | 8 | 11 |
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
| units on a scale | TECH Protocol | Standard Care or Active Standard Care |
|---|---|---|
| Pre intervention | 22.6 ± 1.8 | 22.3 ± 1.9 |
| Post 5 week intervention | 23.1 ± 2.7 | 21.9 ± 2.5 |
| Follow-up after 6 months | 23.3 ± 3.2 | 21.5 ± 2.7 |
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.
| z-score | TECH Protocol | Standard Care or Active Standard Care |
|---|---|---|
| Pre intervention | -0.6 (-1.1 to -0.3) | -0.9 (-1.2 to -0.5) |
| Post 5 weeks intervention | -0.7 (-0.9 to -0.2) | -0.9 (-1.2 to -0.4) |
| Follow up after 6 months | -0.7 (-1.1 to -0.3) | -0.7 (-1.2 to -0.4) |
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.
| units on a scale | TECH Protocol | Standard Care or Active Standard Care |
|---|---|---|
| Pre intervention | 35.0 (30.7 to 37.0) | 35.0 (30.0 to 37.0) |
| Post 5 weeks intervention | 34.5 (30.0 to 36.5) | 33.0 (28.0 to 37.0) |
| Follow up after 6 months | 35.0 (30.7 to 37.2) | 34.0 (29.0 to 37.0) |
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
| units on a scale | TECH Protocol | Standard Care or Active Standard Care |
|---|---|---|
| Physical Composite Pre intervention | 29.5 (24.9 to 29.5) | 29.5 (24.9 to 29.5) |
| Physical Composite Post 5 weeks intervention | 29.5 (23.8 to 29.5) | 29.5 (24.9 to 29.5) |
| Physical Composite Follow up after 6 months | 29.5 (24.9 to 29.5) | 29.5 (24.9 to 29.5) |
| Mental Composite Pre intervention | 46.2 (40.1 to 52.3) | 46.2 (46.2 to 52.3) |
| Mental Composite Post 5 weeks intervention | 52.3 (44.7 to 52.3) | 46.2 (46.2 to 52.3) |
| Mental Composite Follow up after 6 months | 52.3 (40.1 to 52.3) | 46.2 (46.2 to 46.2) |
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).
| units on a scale | TECH Protocol | Standard Care or Active Standard Care |
|---|---|---|
| The Geriatric Depression Scale (GDS) | 2.8 ± 1.8 | 2.7 ± 20. |
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.
Results for this outcome have not been posted.
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.
| Nomber of moves | TECH Protocol | Standard Care or Active Standard Care |
|---|---|---|
| level 1 moves pre | 10.3 ± 3.3 | 14.0 ± 9.6 |
| level 1 moves post | 10.4 ± 3.6 | 11.1 ± 6.9 |
| level 1 moves follow-up | 9.1 ± 2.5 | 12.5 ± 7.9 |
| level 2 moves pre | 24.0 ± 9.2 | 24.1 ± 7.4 |
| level 2 moves post | 24.4 ± 9.2 | 25.4 ± 7.8 |
| level 2 moves follow up | 24.4 ± 13.0 | 23.4 ± 7.1 |
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.
| Seconds | TECH Protocol | Standard Care or Active Standard Care |
|---|---|---|
| level 1 completion time pre | 84.9 ± 51.2 | 98.0 ± 66.8 |
| level 1 completion time post | 60.0 ± 31.1 | 70.2 ± 57.3 |
| level 1 completion time follow up | 60.0 ± 44.9 | 89.7 ± 67.9 |
| level 2 completion time pre | 147.5 ± 59.5 | 138.3 ± 55.9 |
| level 2 completion time post | 148.9 ± 78.5 | 132.7 ± 70.1 |
| level 2 completion time follow up | 143.9 ± 73.2 | 123.0 ± 63.3 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TECH Protocol | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Standard Care or Active Standard Care | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) |
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.
| Age, Continuous(years) | TECH Protocol | Standard Care or Active Standard Care | Total |
|---|---|---|---|
| Mean | 75.6 ± 5.8 | 75.1 ± 6.0 | 75.3 ± 5.8 |
| Sex: Female, Male(Participants) | TECH Protocol | Standard Care or Active Standard Care | Total |
|---|---|---|---|
| Female | 14 | 14 | 28 |
| Male | 16 | 17 | 33 |
| Race/Ethnicity, Customized(Participants) | TECH Protocol | Standard Care or Active Standard Care | Total |
|---|---|---|---|
| Jewish | 30 | 31 | 61 |
| Region of Enrollment(participants) | TECH Protocol | Standard Care or Active Standard Care | Total |
|---|---|---|---|
| Israel | 30 | 31 | 61 |
| Montreal Cognitive Assessment (MoCA)(units on a scale) | TECH Protocol | Standard Care or Active Standard Care | Total |
|---|---|---|---|
| Mean | 22.6 ± 1.8 | 22.3 ± 1.9 | 22.5 ± 1.8 |
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Assuta Hospital Systems