Clinical trial NCT02955277: The Effectiveness of TECH: Tablet Enhancement of Cognition and Health
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Cognitive training
Tablet computers
Lead sponsor: Assuta Hospital Systems
Sponsor class: OTHER
First posted: 2016-11-04
Enrollment: 61
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: The Montreal Cognitive Assessment (MoCA)
timeFrame: pre intervention, post 5 weeks intervention, follow-up after 6 months
Secondary outcomes:
measure: WebNeuro
timeFrame: pre intervention, post 5 weeks intervention, follow-up after 6 months
measure: General Self-Efficacy Scale
timeFrame: pre intervention, post 5 weeks intervention, follow-up after 6 months
measure: The 12-Item Short Form Health Survey (SF-12)
timeFrame: pre intervention, post 5 weeks intervention, follow-up after 6 months
Other outcomes:
measure: The Geriatric Depression Scale (GDS)
timeFrame: Pre intervention
measure: Structural and Functional Magnetic Resonance Imaging (MRI)
timeFrame: pre, post
measure: The Tower of Hanoi (ToH) Task - Nomber of Moves
timeFrame: pre intervention, post 5 weeks intervention, follow-up after 6 months
measure: The Tower of Hanoi (ToH) Task- Complition Time
timeFrame: pre intervention, post 5 weeks intervention, follow-up after 6 months
Locations:
city: Tel Aviv
country: Israel
facility: Maccabi Healthcare Services
Study officials:
affiliation: Maccabi Healthcare Services, Israel
name: Zvi Buckman, MD
role: PRINCIPAL_INVESTIGATOR
References: