The Effectiveness of TECH: Tablet Enhancement of Cognition and Health

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Other: TECH: Tablet Enhancement of Cognition and Health


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TECH protocol<br>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. | Other: TECH: Tablet Enhancement of Cognition and Health<br>* TECH protocol - cognitive training using touchscreen tablet gaming applications<br>|
| No Intervention: standard care<br>Participants will receive standard medical care with no TECH protocol. | |
| Active Comparator: active standard care<br>Partivipans will receive 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. | Other: TECH: Tablet Enhancement of Cognition and Health<br>* TECH protocol - cognitive training using touchscreen tablet gaming applications<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Montreal Cognitive Assessment | A cognitive screening tool with high sensitivity and specificity, aimed to distinguish individuals with MCI from healthy adults. The MoCA assesses eight cognitive domains: attention and concentration, executive functions, memory, language, visuo-constructional skills, conceptual thinking, calculations, and orientation. | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 20 minutes | 
| The Tower of Hanoi (ToH) task | A commonly used goal-directed measure assessing problem-solving, and specifically, planning. The ToH consists of three bars and three to eight different-sized disks that can slide onto any bar. The objective of the task is to move an entire stack (organized in ascending order of size on one bar) to another bar while obeying two rules: Only one disk can be moved at a time and no disk may be placed on top of a smaller disk. The score of the task is the number of moves for achieving each level. A computerized version of the task will be used (http://vornlocher.de/tower). | 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive training, Tablet computers