The Effectiveness of TECH: Tablet Enhancement of Cognition and Health

Not Applicable

Completed

Conditions: Mild Cognitive Impairment

Interventions: Other: Standard care or active standard care

Registration Number: NCT02955277

Lead Sponsor: Assuta Hospital Systems

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 61

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard care or active standard care	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.