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The Effectiveness of TECH: Tablet Enhancement of Cognition and Health (TECH)

Primary Purpose

Mild Cognitive Impairment

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
TECH: Tablet Enhancement of Cognition and Health
Sponsored by
Assuta Hospital Systems
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Cognitive training, Tablet computers

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Maccabi Healthcare ServicesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Active Comparator

Arm Label

TECH protocol

standard care

active standard care

Arm Description

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.

Participants will receive standard medical care with no TECH protocol.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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).

Full Information

First Posted
November 2, 2016
Last Updated
April 8, 2020
Sponsor
Assuta Hospital Systems
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1. Study Identification

Unique Protocol Identification Number
NCT02955277
Brief Title
The Effectiveness of TECH: Tablet Enhancement of Cognition and Health
Acronym
TECH
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

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
August 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assuta Hospital Systems

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Cognitive training, Tablet computers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TECH protocol
Arm Type
Experimental
Arm Description
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.
Arm Title
standard care
Arm Type
No Intervention
Arm Description
Participants will receive standard medical care with no TECH protocol.
Arm Title
active standard care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
TECH: Tablet Enhancement of Cognition and Health
Intervention Description
TECH protocol - cognitive training using touchscreen tablet gaming applications
Primary Outcome Measure Information:
Title
The Montreal Cognitive Assessment
Description
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.
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
WebNeuro
Description
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).
Time Frame
20 minutes
Title
The Tower of Hanoi (ToH) task
Description
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).
Time Frame
10 minutes
Other Pre-specified Outcome Measures:
Title
The 12-Item Short Form Health Survey (SF-12)
Description
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.
Time Frame
8 minutes
Title
General Self-Efficacy Scale
Description
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.
Time Frame
8 minutes
Title
The Lawton Instrumental Activities of Daily Living (IADL) Scale
Description
This reliable and valid self-report measurement consists of eight items (telephone use, shopping groceries, food preparation, housekeeping, laundry, transportation, medication use, and handling finances). Each item has three answer categories (not able, able with support, independent). The total score ranges from 0 (completely dependent) to 23 (completely independent).
Time Frame
8 minutes
Title
The Geriatric Depression Scale (GDS)
Description
Valid and reliable self-rating screening tool developed to detect depressive symptoms in elderly (D'ath, Katona, Mullan, Evans, & Katona, 1994; Lesher & Berryhill, 1994). The questionnaire includes 15 yes/no statements and takes up to10 minutes to complete. Score above 10 points indicates the presence of depressive symptoms (Yesavage et al., 1983).
Time Frame
8 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Noa Givon, MSc OT
Phone
+972543455303
Email
noagivon@post.tau.ac.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zvi Buckman, MD
Organizational Affiliation
Maccabi Healthcare Services, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maccabi Healthcare Services
City
Tel Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michal Yanai
Phone
+97237952427
Email
yanai_m@mac.org.il
First Name & Middle Initial & Last Name & Degree
Noa Givon, MSc

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Effectiveness of TECH: Tablet Enhancement of Cognition and Health

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