The Effectiveness of TECH: Tablet Enhancement of Cognition and Health

NCT02955277 | Completed Results

• 1 other identifier: 2016009-1
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Keywords

Cognitive training; Tablet computers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• The 12-Item Short Form Health Survey (SF-12)

  pre intervention, post 5 weeks intervention, follow-up after 6 months

Other Outcomes (4)

• The Geriatric Depression Scale (GDS)

  Pre intervention

• Structural and Functional Magnetic Resonance Imaging (MRI)

  pre, post

• The Tower of Hanoi (ToH) Task - Nomber of Moves

  pre intervention, post 5 weeks intervention, follow-up after 6 months

Study Arms (2)

TECH protocol

EXPERIMENTAL

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 protocol

standard care or active standard care

ACTIVE COMPARATOR

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.

Other: Standard care or active standard care

Interventions

TECH: Tablet Enhancement of Cognition and Health protocol OTHER

Cognitive training using touchscreen tablets (TECH protocol)

TECH protocol

Standard care or active standard care OTHER

standard occupational therapy or 6-weekly group sessions playing board games and puzzles.

standard care or active standard care

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Assuta Hospital Systems: lead

Study Sites (1)

Maccabi Healthcare Services

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dr. Zvi Buckman
• Organization: Assuta Hospital Systems

Bukman_tz@mac.org.il

+97237462520

Study Officials

• Zvi Buckman, MD

  Maccabi Healthcare Services, Israel

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors were blind to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Zvi Buckman

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: November 4, 2016
• Study Start: January 4, 2017
• Primary Completion: March 20, 2020
• Study Completion: March 20, 2020
• Last Updated: March 1, 2024
• Results First Posted: March 1, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)