Trial Outcomes & Findings for The Effectiveness of TECH: Tablet Enhancement of Cognition and Health (NCT NCT02955277)
NCT ID: NCT02955277
Last Updated: 2024-03-01
Results Overview
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
COMPLETED
NA
61 participants
pre intervention, post 5 weeks intervention, follow-up after 6 months
2024-03-01
Participant Flow
Participant milestones
| Measure |
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)
|
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.
|
|---|---|---|
|
Pre-Post Intervention
STARTED
|
30
|
31
|
|
Pre-Post Intervention
COMPLETED
|
25
|
25
|
|
Pre-Post Intervention
NOT COMPLETED
|
5
|
6
|
|
Post to Follow-up
STARTED
|
25
|
25
|
|
Post to Follow-up
COMPLETED
|
17
|
14
|
|
Post to Follow-up
NOT COMPLETED
|
8
|
11
|
Reasons for withdrawal
| Measure |
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)
|
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.
|
|---|---|---|
|
Pre-Post Intervention
Withdrawal by Subject
|
5
|
6
|
|
Post to Follow-up
Lost to Follow-up
|
8
|
11
|
Baseline Characteristics
The Effectiveness of TECH: Tablet Enhancement of Cognition and Health
Baseline characteristics by cohort
| Measure |
TECH Protocol
n=30 Participants
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)
|
Standard Care or Active Standard Care
n=31 Participants
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.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75.6 years
STANDARD_DEVIATION 5.8 • n=99 Participants
|
75.1 years
STANDARD_DEVIATION 6.0 • n=107 Participants
|
75.3 years
STANDARD_DEVIATION 5.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Jewish
|
30 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Region of Enrollment
Israel
|
30 participants
n=99 Participants
|
31 participants
n=107 Participants
|
61 participants
n=206 Participants
|
|
Montreal Cognitive Assessment (MoCA)
|
22.6 units on a scale
STANDARD_DEVIATION 1.8 • n=99 Participants
|
22.3 units on a scale
STANDARD_DEVIATION 1.9 • n=107 Participants
|
22.5 units on a scale
STANDARD_DEVIATION 1.8 • n=206 Participants
|
PRIMARY outcome
Timeframe: pre intervention, post 5 weeks intervention, follow-up after 6 monthsA 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
Outcome measures
| Measure |
TECH Protocol
n=30 Participants
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)
|
Standard Care or Active Standard Care
n=31 Participants
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.
|
|---|---|---|
|
The Montreal Cognitive Assessment (MoCA)
Pre intervention
|
22.6 units on a scale
Standard Deviation 1.8
|
22.3 units on a scale
Standard Deviation 1.9
|
|
The Montreal Cognitive Assessment (MoCA)
Post 5 week intervention
|
23.1 units on a scale
Standard Deviation 2.7
|
21.9 units on a scale
Standard Deviation 2.5
|
|
The Montreal Cognitive Assessment (MoCA)
Follow-up after 6 months
|
23.3 units on a scale
Standard Deviation 3.2
|
21.5 units on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: pre intervention, post 5 weeks intervention, follow-up after 6 monthsA 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.
Outcome measures
| Measure |
TECH Protocol
n=30 Participants
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)
|
Standard Care or Active Standard Care
n=31 Participants
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.
|
|---|---|---|
|
WebNeuro
Pre intervention
|
-0.6 z-score
Interval -1.1 to -0.3
|
-0.9 z-score
Interval -1.2 to -0.5
|
|
WebNeuro
Post 5 weeks intervention
|
-0.7 z-score
Interval -0.9 to -0.2
|
-0.9 z-score
Interval -1.2 to -0.4
|
|
WebNeuro
Follow up after 6 months
|
-0.7 z-score
Interval -1.1 to -0.3
|
-0.7 z-score
Interval -1.2 to -0.4
|
SECONDARY outcome
Timeframe: pre intervention, post 5 weeks intervention, follow-up after 6 monthsDesigned 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.
Outcome measures
| Measure |
TECH Protocol
n=30 Participants
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)
|
Standard Care or Active Standard Care
n=31 Participants
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.
|
|---|---|---|
|
General Self-Efficacy Scale
Pre intervention
|
35.0 units on a scale
Interval 30.7 to 37.0
|
35.0 units on a scale
Interval 30.0 to 37.0
|
|
General Self-Efficacy Scale
Post 5 weeks intervention
|
34.5 units on a scale
Interval 30.0 to 36.5
|
33.0 units on a scale
Interval 28.0 to 37.0
|
|
General Self-Efficacy Scale
Follow up after 6 months
|
35.0 units on a scale
Interval 30.7 to 37.2
|
34.0 units on a scale
Interval 29.0 to 37.0
|
SECONDARY outcome
Timeframe: pre intervention, post 5 weeks intervention, follow-up after 6 monthsSF-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
Outcome measures
| Measure |
TECH Protocol
n=30 Participants
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)
|
Standard Care or Active Standard Care
n=31 Participants
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.
|
|---|---|---|
|
The 12-Item Short Form Health Survey (SF-12)
Physical Composite Pre intervention
|
29.5 units on a scale
Interval 24.9 to 29.5
|
29.5 units on a scale
Interval 24.9 to 29.5
|
|
The 12-Item Short Form Health Survey (SF-12)
Physical Composite Post 5 weeks intervention
|
29.5 units on a scale
Interval 23.8 to 29.5
|
29.5 units on a scale
Interval 24.9 to 29.5
|
|
The 12-Item Short Form Health Survey (SF-12)
Physical Composite Follow up after 6 months
|
29.5 units on a scale
Interval 24.9 to 29.5
|
29.5 units on a scale
Interval 24.9 to 29.5
|
|
The 12-Item Short Form Health Survey (SF-12)
Mental Composite Pre intervention
|
46.2 units on a scale
Interval 40.1 to 52.3
|
46.2 units on a scale
Interval 46.2 to 52.3
|
|
The 12-Item Short Form Health Survey (SF-12)
Mental Composite Post 5 weeks intervention
|
52.3 units on a scale
Interval 44.7 to 52.3
|
46.2 units on a scale
Interval 46.2 to 52.3
|
|
The 12-Item Short Form Health Survey (SF-12)
Mental Composite Follow up after 6 months
|
52.3 units on a scale
Interval 40.1 to 52.3
|
46.2 units on a scale
Interval 46.2 to 46.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre interventionValid 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).
Outcome measures
| Measure |
TECH Protocol
n=30 Participants
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)
|
Standard Care or Active Standard Care
n=31 Participants
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.
|
|---|---|---|
|
The Geriatric Depression Scale (GDS)
|
2.8 units on a scale
Standard Deviation 1.8
|
2.7 units on a scale
Standard Deviation 20.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: pre, postChanges 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: pre intervention, post 5 weeks intervention, follow-up after 6 monthsA 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.
Outcome measures
| Measure |
TECH Protocol
n=30 Participants
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)
|
Standard Care or Active Standard Care
n=31 Participants
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.
|
|---|---|---|
|
The Tower of Hanoi (ToH) Task - Nomber of Moves
level 1 moves pre
|
10.3 Nomber of moves
Standard Deviation 3.3
|
14.0 Nomber of moves
Standard Deviation 9.6
|
|
The Tower of Hanoi (ToH) Task - Nomber of Moves
level 1 moves post
|
10.4 Nomber of moves
Standard Deviation 3.6
|
11.1 Nomber of moves
Standard Deviation 6.9
|
|
The Tower of Hanoi (ToH) Task - Nomber of Moves
level 1 moves follow-up
|
9.1 Nomber of moves
Standard Deviation 2.5
|
12.5 Nomber of moves
Standard Deviation 7.9
|
|
The Tower of Hanoi (ToH) Task - Nomber of Moves
level 2 moves pre
|
24.0 Nomber of moves
Standard Deviation 9.2
|
24.1 Nomber of moves
Standard Deviation 7.4
|
|
The Tower of Hanoi (ToH) Task - Nomber of Moves
level 2 moves post
|
24.4 Nomber of moves
Standard Deviation 9.2
|
25.4 Nomber of moves
Standard Deviation 7.8
|
|
The Tower of Hanoi (ToH) Task - Nomber of Moves
level 2 moves follow up
|
24.4 Nomber of moves
Standard Deviation 13.0
|
23.4 Nomber of moves
Standard Deviation 7.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: pre intervention, post 5 weeks intervention, follow-up after 6 monthsA 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.
Outcome measures
| Measure |
TECH Protocol
n=30 Participants
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)
|
Standard Care or Active Standard Care
n=31 Participants
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.
|
|---|---|---|
|
The Tower of Hanoi (ToH) Task- Complition Time
level 2 completion time pre
|
147.5 Seconds
Standard Deviation 59.5
|
138.3 Seconds
Standard Deviation 55.9
|
|
The Tower of Hanoi (ToH) Task- Complition Time
level 2 completion time post
|
148.9 Seconds
Standard Deviation 78.5
|
132.7 Seconds
Standard Deviation 70.1
|
|
The Tower of Hanoi (ToH) Task- Complition Time
level 1 completion time pre
|
84.9 Seconds
Standard Deviation 51.2
|
98.0 Seconds
Standard Deviation 66.8
|
|
The Tower of Hanoi (ToH) Task- Complition Time
level 1 completion time post
|
60.0 Seconds
Standard Deviation 31.1
|
70.2 Seconds
Standard Deviation 57.3
|
|
The Tower of Hanoi (ToH) Task- Complition Time
level 1 completion time follow up
|
60.0 Seconds
Standard Deviation 44.9
|
89.7 Seconds
Standard Deviation 67.9
|
|
The Tower of Hanoi (ToH) Task- Complition Time
level 2 completion time follow up
|
143.9 Seconds
Standard Deviation 73.2
|
123.0 Seconds
Standard Deviation 63.3
|
Adverse Events
TECH Protocol
Standard Care or Active Standard Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place