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

• ClinicalTrials.gov Identifier: NCT02955277
• Recruitment Status: Recruiting
• First Posted: November 4, 2016
• Last Update Posted: October 18, 2018
• Sponsor: Assuta Hospital Systems
• Information provided by (Responsible Party): Zvi Buckman, Assuta Hospital Systems

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. Forty six 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.

Condition or disease	Intervention/treatment	Phase
Mild Cognitive Impairment	Other: TECH: Tablet Enhancement of Cognition and Health	Not Applicable

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 follow-up assessment six months later.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: November 2016
• Estimated Primary Completion Date: June 2019
• Estimated Study Completion Date: August 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: TECH protocol; 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; TECH protocol - cognitive training using touchscreen tablet gaming applications
No Intervention: standard care; Participants will receive standard medical care with no TECH protocol.
Active Comparator: active standard care; 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; TECH protocol - cognitive training using touchscreen tablet gaming applications

Outcome Measures

Primary Outcome Measures :

1. WebNeuro [ Time Frame: 20 minutes ]
   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).

Secondary Outcome Measures :

1. The Montreal Cognitive Assessment [ Time Frame: 10 minutes ]
   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.
2. The Tower of Hanoi (ToH) task [ Time Frame: 10 minutes ]
   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).

Other Outcome Measures:

1. The 12-Item Short Form Health Survey (SF-12) [ Time Frame: 8 minutes ]

   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.

2. General Self-Efficacy Scale [ Time Frame: 8 minutes ]
   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.
3. The Lawton Instrumental Activities of Daily Living (IADL) Scale [ Time Frame: 8 minutes ]
   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).
4. The Geriatric Depression Scale (GDS) [ Time Frame: 8 minutes ]
   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).

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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).

Contacts and Locations

Contacts

Contact: Noa Givon, MSc OT; +972543455303; noagivon@post.tau.ac.il

Locations

Israel

Maccabi Healthcare Services; Recruiting

Tel Aviv, Israel

Contact: Michal Yanai +97237952427 yanai_m@mac.org.il

Principal Investigator: Noa Givon, MSc

Sponsors and Collaborators

Assuta Hospital Systems

Investigators

• Principal Investigator: Zvi Buckman, MD; Maccabi Healthcare Services, Israel

More Information

• Responsible Party: Zvi Buckman, Dr. Zvi Buckman, Assuta Hospital Systems
• ClinicalTrials.gov Identifier: NCT02955277 History of Changes
• Other Study ID Numbers: 2016009-1
• First Posted: November 4, 2016
• Last Update Posted: October 18, 2018
• Last Verified: October 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by Zvi Buckman, Assuta Hospital Systems:

Cognitive training; Tablet computers

Additional relevant MeSH terms:

Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders