Mild Cognitive Impairment
Conditions
Keywords
Cognitive training, Tablet computers
Brief summary
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.
Detailed description
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.
Interventions
OTHERTECH: Tablet Enhancement of Cognition and Health protocol
Cognitive training using touchscreen tablets (TECH protocol)
OTHERStandard care or active standard care
standard occupational therapy or 6-weekly group sessions playing board games and puzzles.
Sponsors
Assuta Hospital Systems
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessors were blind to group allocation.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Aged 65 and above. * Have MCI (as determined by the following four criterions: A. a score of 19-25 on the MoCA, B. subjective memory complaints, and report from an informant of the same memory complains (the informant should be a person who interacts with the participant three or more times a week), C. Informant report of the cognitive decline as newly acquired, D. independence in Basic Activities of Daily Living (BADL) and Instrumental Activities of Daily Living (IADL), as reported by the participants and the informant, excluding motor difficulties which are not caused due to neurological conditions or lack of performance with no changes compared to the past. * Have normal or corrected vision and hearing. * Speak, write and read Hebrew. * Able to understand and follow use of the touchscreen of a tablet after initial demonstration.
Exclusion criteria
* Experience severe depressive symptoms (10 points or more in The Geriatric Depression Scale) * Are diagnosed with dementia, or other neurological or psychiatric condition (such as stroke, Parkinson's disease).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Montreal Cognitive Assessment (MoCA) | pre intervention, post 5 weeks intervention, follow-up after 6 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| WebNeuro | pre intervention, post 5 weeks intervention, follow-up after 6 months | 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. |
| General Self-Efficacy Scale | pre intervention, post 5 weeks intervention, follow-up after 6 months | 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. |
| The 12-Item Short Form Health Survey (SF-12) | pre intervention, post 5 weeks intervention, follow-up after 6 months | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| The Geriatric Depression Scale (GDS) | Pre intervention | 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). |
| Structural and Functional Magnetic Resonance Imaging (MRI) | pre, post | 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. |
| The Tower of Hanoi (ToH) Task - Nomber of Moves | pre intervention, post 5 weeks intervention, follow-up after 6 months | 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. |
| The Tower of Hanoi (ToH) Task- Complition Time | pre intervention, post 5 weeks intervention, follow-up after 6 months | 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. |
Countries
Israel
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 30 |
| 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. | 31 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Post to Follow-up | Lost to Follow-up | 8 | 11 |
| Pre-Post Intervention | Withdrawal by Subject | 5 | 6 |
Baseline characteristics
| Characteristic | TECH Protocol | Standard Care or Active Standard Care | Total |
|---|---|---|---|
| Age, Continuous | 75.6 years STANDARD_DEVIATION 5.8 | 75.1 years STANDARD_DEVIATION 6 | 75.3 years STANDARD_DEVIATION 5.8 |
| Montreal Cognitive Assessment (MoCA) | 22.6 units on a scale STANDARD_DEVIATION 1.8 | 22.3 units on a scale STANDARD_DEVIATION 1.9 | 22.5 units on a scale STANDARD_DEVIATION 1.8 |
| Race/Ethnicity, Customized Jewish | 30 Participants | 31 Participants | 61 Participants |
| Region of Enrollment Israel | 30 participants | 31 participants | 61 participants |
| Sex: Female, Male Female | 14 Participants | 14 Participants | 28 Participants |
| Sex: Female, Male Male | 16 Participants | 17 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 31 |
| other Total, other adverse events | 0 / 30 | 0 / 31 |
| serious Total, serious adverse events | 0 / 30 | 0 / 31 |
Outcome results
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
Time frame: pre intervention, post 5 weeks intervention, follow-up after 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TECH Protocol | The Montreal Cognitive Assessment (MoCA) | Pre intervention | 22.6 units on a scale | Standard Deviation 1.8 |
| TECH Protocol | The Montreal Cognitive Assessment (MoCA) | Post 5 week intervention | 23.1 units on a scale | Standard Deviation 2.7 |
| TECH Protocol | The Montreal Cognitive Assessment (MoCA) | Follow-up after 6 months | 23.3 units on a scale | Standard Deviation 3.2 |
| Standard Care or Active Standard Care | The Montreal Cognitive Assessment (MoCA) | Pre intervention | 22.3 units on a scale | Standard Deviation 1.9 |
| Standard Care or Active Standard Care | The Montreal Cognitive Assessment (MoCA) | Post 5 week intervention | 21.9 units on a scale | Standard Deviation 2.5 |
| Standard Care or Active Standard Care | The Montreal Cognitive Assessment (MoCA) | Follow-up after 6 months | 21.5 units on a scale | Standard Deviation 2.7 |
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.
Time frame: pre intervention, post 5 weeks intervention, follow-up after 6 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TECH Protocol | General Self-Efficacy Scale | Pre intervention | 35.0 units on a scale |
| TECH Protocol | General Self-Efficacy Scale | Post 5 weeks intervention | 34.5 units on a scale |
| TECH Protocol | General Self-Efficacy Scale | Follow up after 6 months | 35.0 units on a scale |
| Standard Care or Active Standard Care | General Self-Efficacy Scale | Pre intervention | 35.0 units on a scale |
| Standard Care or Active Standard Care | General Self-Efficacy Scale | Post 5 weeks intervention | 33.0 units on a scale |
| Standard Care or Active Standard Care | General Self-Efficacy Scale | Follow up after 6 months | 34.0 units on a scale |
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
Time frame: pre intervention, post 5 weeks intervention, follow-up after 6 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TECH Protocol | The 12-Item Short Form Health Survey (SF-12) | Mental Composite Follow up after 6 months | 52.3 units on a scale |
| TECH Protocol | The 12-Item Short Form Health Survey (SF-12) | Physical Composite Post 5 weeks intervention | 29.5 units on a scale |
| TECH Protocol | The 12-Item Short Form Health Survey (SF-12) | Mental Composite Post 5 weeks intervention | 52.3 units on a scale |
| TECH Protocol | The 12-Item Short Form Health Survey (SF-12) | Physical Composite Follow up after 6 months | 29.5 units on a scale |
| TECH Protocol | The 12-Item Short Form Health Survey (SF-12) | Physical Composite Pre intervention | 29.5 units on a scale |
| TECH Protocol | The 12-Item Short Form Health Survey (SF-12) | Mental Composite Pre intervention | 46.2 units on a scale |
| Standard Care or Active Standard Care | The 12-Item Short Form Health Survey (SF-12) | Physical Composite Pre intervention | 29.5 units on a scale |
| Standard Care or Active Standard Care | The 12-Item Short Form Health Survey (SF-12) | Mental Composite Post 5 weeks intervention | 46.2 units on a scale |
| Standard Care or Active Standard Care | The 12-Item Short Form Health Survey (SF-12) | Mental Composite Follow up after 6 months | 46.2 units on a scale |
| Standard Care or Active Standard Care | The 12-Item Short Form Health Survey (SF-12) | Mental Composite Pre intervention | 46.2 units on a scale |
| Standard Care or Active Standard Care | The 12-Item Short Form Health Survey (SF-12) | Physical Composite Post 5 weeks intervention | 29.5 units on a scale |
| Standard Care or Active Standard Care | The 12-Item Short Form Health Survey (SF-12) | Physical Composite Follow up after 6 months | 29.5 units on a scale |
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.
Time frame: pre intervention, post 5 weeks intervention, follow-up after 6 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TECH Protocol | WebNeuro | Post 5 weeks intervention | -0.7 z-score |
| TECH Protocol | WebNeuro | Pre intervention | -0.6 z-score |
| TECH Protocol | WebNeuro | Follow up after 6 months | -0.7 z-score |
| Standard Care or Active Standard Care | WebNeuro | Post 5 weeks intervention | -0.9 z-score |
| Standard Care or Active Standard Care | WebNeuro | Pre intervention | -0.9 z-score |
| Standard Care or Active Standard Care | WebNeuro | Follow up after 6 months | -0.7 z-score |
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.
Time frame: pre, post
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).
Time frame: Pre intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TECH Protocol | The Geriatric Depression Scale (GDS) | 2.8 units on a scale | Standard Deviation 1.8 |
| Standard Care or Active Standard Care | The Geriatric Depression Scale (GDS) | 2.7 units on a scale | — |
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.
Time frame: pre intervention, post 5 weeks intervention, follow-up after 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TECH Protocol | The Tower of Hanoi (ToH) Task- Complition Time | level 1 completion time pre | 84.9 Seconds | Standard Deviation 51.2 |
| TECH Protocol | The Tower of Hanoi (ToH) Task- Complition Time | level 1 completion time post | 60.0 Seconds | Standard Deviation 31.1 |
| TECH Protocol | The Tower of Hanoi (ToH) Task- Complition Time | level 1 completion time follow up | 60.0 Seconds | Standard Deviation 44.9 |
| TECH Protocol | The Tower of Hanoi (ToH) Task- Complition Time | level 2 completion time pre | 147.5 Seconds | Standard Deviation 59.5 |
| TECH Protocol | The Tower of Hanoi (ToH) Task- Complition Time | level 2 completion time post | 148.9 Seconds | Standard Deviation 78.5 |
| TECH Protocol | The Tower of Hanoi (ToH) Task- Complition Time | level 2 completion time follow up | 143.9 Seconds | Standard Deviation 73.2 |
| Standard Care or Active Standard Care | The Tower of Hanoi (ToH) Task- Complition Time | level 2 completion time post | 132.7 Seconds | Standard Deviation 70.1 |
| Standard Care or Active Standard Care | The Tower of Hanoi (ToH) Task- Complition Time | level 1 completion time pre | 98.0 Seconds | Standard Deviation 66.8 |
| Standard Care or Active Standard Care | The Tower of Hanoi (ToH) Task- Complition Time | level 2 completion time pre | 138.3 Seconds | Standard Deviation 55.9 |
| Standard Care or Active Standard Care | The Tower of Hanoi (ToH) Task- Complition Time | level 1 completion time post | 70.2 Seconds | Standard Deviation 57.3 |
| Standard Care or Active Standard Care | The Tower of Hanoi (ToH) Task- Complition Time | level 2 completion time follow up | 123.0 Seconds | Standard Deviation 63.3 |
| Standard Care or Active Standard Care | The Tower of Hanoi (ToH) Task- Complition Time | level 1 completion time follow up | 89.7 Seconds | Standard Deviation 67.9 |
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.
Time frame: pre intervention, post 5 weeks intervention, follow-up after 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TECH Protocol | The Tower of Hanoi (ToH) Task - Nomber of Moves | level 1 moves post | 10.4 Nomber of moves | Standard Deviation 3.6 |
| TECH Protocol | The Tower of Hanoi (ToH) Task - Nomber of Moves | level 2 moves pre | 24.0 Nomber of moves | Standard Deviation 9.2 |
| TECH Protocol | The Tower of Hanoi (ToH) Task - Nomber of Moves | level 2 moves post | 24.4 Nomber of moves | Standard Deviation 9.2 |
| TECH Protocol | The Tower of Hanoi (ToH) Task - Nomber of Moves | level 1 moves pre | 10.3 Nomber of moves | Standard Deviation 3.3 |
| TECH Protocol | The Tower of Hanoi (ToH) Task - Nomber of Moves | level 2 moves follow up | 24.4 Nomber of moves | Standard Deviation 13 |
| TECH Protocol | The Tower of Hanoi (ToH) Task - Nomber of Moves | level 1 moves follow-up | 9.1 Nomber of moves | Standard Deviation 2.5 |
| Standard Care or Active Standard Care | The Tower of Hanoi (ToH) Task - Nomber of Moves | level 2 moves follow up | 23.4 Nomber of moves | Standard Deviation 7.1 |
| Standard Care or Active Standard Care | The Tower of Hanoi (ToH) Task - Nomber of Moves | level 1 moves pre | 14.0 Nomber of moves | Standard Deviation 9.6 |
| Standard Care or Active Standard Care | The Tower of Hanoi (ToH) Task - Nomber of Moves | level 1 moves post | 11.1 Nomber of moves | Standard Deviation 6.9 |
| Standard Care or Active Standard Care | The Tower of Hanoi (ToH) Task - Nomber of Moves | level 1 moves follow-up | 12.5 Nomber of moves | Standard Deviation 7.9 |
| Standard Care or Active Standard Care | The Tower of Hanoi (ToH) Task - Nomber of Moves | level 2 moves post | 25.4 Nomber of moves | Standard Deviation 7.8 |
| Standard Care or Active Standard Care | The Tower of Hanoi (ToH) Task - Nomber of Moves | level 2 moves pre | 24.1 Nomber of moves | Standard Deviation 7.4 |