Healthy AdultsNCT02955303
The Feasibility of TECH: Tablet Enhancement of Cognition and Health for Healthy Adults
A study testing TECH: Tablet Enhancement of Cognition and Health in people with Healthy Adults, run by Assuta Hospital Systems at 1 site in Israel.
Trial summary
This study assess the feasibility of novel cognitive intervention utilizing tablet apps (TECH protocol: Tablet Enhancement of Cognition and Health) in terms of relevance, adherence, suitable challenges, training time etc. for healthy older adults. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- TECH: Tablet Enhancement of Cognition and Health
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2016to Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Aged 65 and above.
- Without cognitive decline (score 26 points or above in MoCA).
- ) live independently in the community (as reported by the participants, regarding their independence in BADL and IADL, 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Feasibility of TECH: Tablet Enhancement of Cognition and Health, Cognitive Training Using Touchscreen Tablet Gaming Applications, for Healthy Older Adults - a Pilot Randomized Control Trial
This study assess the feasibility of novel cognitive intervention utilizing tablet apps (TECH protocol: Tablet Enhancement of Cognition and Health) in terms of relevance, adherence, suitable challenges, training time etc. for healthy older adults. Older adults with normal cognition will be randomly allocated to the TECH protocol (experimental group) or the control group (no treatment). Assessments will be administered pre and post the 6-week TECH protocol by assessors blind to group allocation.
Read the detailed description
A pre-post pilot study will be conducted. 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 receive the TECH protocol, and following the intervention a second assessment will be performed.
- Conditions
- Healthy Adults
- Being tested
- TECH: Tablet Enhancement of Cognition and Health
- Keywords
- Cognitive training, Tablet computers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TECH: Tablet Enhancement of Cognition and HealthOther
cognitive training using touchscreen tablet gaming applications
| Study group | Role | What they receive |
|---|---|---|
| TECH protocol | Experimental | 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 15-20 training sessions. In addition they will use the tablets for a variety of everyday uses. The individual self-training will be accompanied by five weekly sessions (of 60-90 minutes) in a small group setting (5-6 participants) led by an experienced occupational therapist. For initial learning of the tablet's basic use, an individual session for each participant will take place. Receives: Other: TECH: Tablet Enhancement of Cognition and Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility information
Information regarding: Adherence - the percentage of session attendance out of the six weekly group sessions; Compliance - assessed by the total self-training hours a week, which was taken from participant's daily logs and iPad Screen time information. Satisfaction from the intervention was rated by the participants after completion of the TECH intervention.
Measured: 7 minutes
Secondary outcomes (3)
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.
Measured: 10 minutes
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).
Measured: 20 minutes
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).
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionJun 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assuta Hospital Systems
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zvi Buckman, Assuta Hospital Systems
- Investigators
- Zvi Buckman, MD, Principal investigator, Maccabi Healthcare Services, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02955303
- Sponsor's protocol ID
- 2016009-2
- Status last verified
- Jan 2020
- First submitted
- 2 Nov 2016
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of TECH: Tablet Enhancement of Cognition and Health, Cognitive Training Using Touchscreen Tablet Gaming Applications, for Healthy Older Adults - a Pilot Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02955303
- Acronym / sponsor ID
- 2016009-2
- Conditions
- Healthy Adults
- Keywords
- Cognitive training, Tablet computers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Assuta Hospital SystemsUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Jun 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 4 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study assess the feasibility of novel cognitive intervention utilizing tablet apps (TECH protocol: Tablet Enhancement of Cognition and Health) in terms of relevance, adherence, suitable challenges, training time etc. for healthy older adults. Older adults with normal cognition will be randomly allocated to the TECH protocol (experimental group) or the control group (no treatment). Assessments will be administered pre and post the 6-week TECH protocol by assessors blind to group allocation.
Detailed description
A pre-post pilot study will be conducted. 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 receive the TECH protocol, and following the intervention a second assessment will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TECH protocol | Experimental | Other: TECH: Tablet Enhancement of Cognition and HealthDaily 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 15-20 training sessions. In addition they will use the tablets for a variety of everyday uses. The individual self-training will be accompanied by five weekly sessions (of 60-90 minutes) in a small group setting (5-6 participants) led by an experienced occupational therapist. For initial learning of the tablet's basic use, an individual session for each participant will take place. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Aged 65 and above.
- Without cognitive decline (score 26 points or above in MoCA).
- ) live independently in the community (as reported by the participants, regarding their independence in BADL and IADL, 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TECH: Tablet Enhancement of Cognition and Healthcognitive training using touchscreen tablet gaming applications | Other | TECH protocol |
Primary outcome
Feasibility information
Time frame: 7 minutes
Information regarding: Adherence - the percentage of session attendance out of the six weekly group sessions; Compliance - assessed by the total self-training hours a week, which was taken from participant's daily logs and iPad Screen time information. Satisfaction from the intervention was rated by the participants after completion of the TECH intervention.
3 secondary outcomes
The Montreal Cognitive Assessment
Time frame: 10 minutes
WebNeuro
Time frame: 20 minutes
The Tower of Hanoi (ToH) task
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zvi Buckman, MD principal investigator
Maccabi Healthcare Services, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TECH: Tablet Enhancement of Cognition and Health in people with Healthy Adults, run by Assuta Hospital Systems at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility information (time frame: 7 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020; AzTrials last refreshed its copy on 8 Nov 2026.