The Effectiveness of TECH: Tablet Enhancement of Cognition and Health

Mild Cognitive Impairment Clinical Trial

— TECH  

Official title:

The Effectiveness of TECH: Tablet Enhancement of Cognition and Health, Cognitive Training Using Touchscreen Tablet Gaming Applications, for Older Adults With Mild Cognitive Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02955277
• Other study ID #: 2016009-1
• Status: Completed
• Phase: N/A
• Start date: January 4, 2017
• Est. completion date: March 20, 2020

Study information

• Verified date: August 2023
• Source: Assuta Hospital Systems
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: March 20, 2020
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Other:
• TECH: Tablet Enhancement of Cognition and Health protocol
Cognitive training using touchscreen tablets (TECH protocol)
• Standard care or active standard care
standard occupational therapy or 6-weekly group sessions playing board games and puzzles.

Locations

Country	Name	City	State
Israel	Maccabi Healthcare Services	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Assuta Hospital Systems

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).	Pre intervention
Other	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
Other	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
Other	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
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	pre intervention, post 5 weeks intervention, follow-up after 6 months
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.	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.	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	pre intervention, post 5 weeks intervention, follow-up after 6 months