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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

61 participants

Primary outcome timeframe

pre intervention, post 5 weeks intervention, follow-up after 6 months

Results posted on

2024-03-01

Participant Flow

Participant milestones

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

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

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 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

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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 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

Outcome measures

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 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).

Outcome measures

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, 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

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 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.

Outcome measures

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Standard Care or Active Standard Care

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Zvi Buckman

Assuta Hospital Systems

Phone: +97237462520

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place