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Clinical Trials/NCT02955277
NCT02955277
Completed
Not Applicable

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

Assuta Hospital Systems1 site in 1 country61 target enrollmentJanuary 4, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mild Cognitive Impairment
Sponsor
Assuta Hospital Systems
Enrollment
61
Locations
1
Primary Endpoint
The Montreal Cognitive Assessment (MoCA)
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 4, 2017
End Date
March 20, 2020
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Assuta Hospital Systems
Responsible Party
Principal Investigator
Principal Investigator

Zvi Buckman

Dr. Zvi Buckman

Assuta Hospital Systems

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).

Outcomes

Primary Outcomes

The Montreal Cognitive Assessment (MoCA)

Time Frame: 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 Outcomes

  • The 12-Item Short Form Health Survey (SF-12)(pre intervention, post 5 weeks intervention, follow-up after 6 months)
  • WebNeuro(pre intervention, post 5 weeks intervention, follow-up after 6 months)
  • General Self-Efficacy Scale(pre intervention, post 5 weeks intervention, follow-up after 6 months)

Study Sites (1)

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