Mild Cognitive ImpairmentPhase 2NCT04679441
A Novel Computer-Based Functional Skills Assessment and Training Program
A Phase 2 study testing The Computerized Functional Skills Assessment and Training Program and Brain HQ Double Decision in people with Mild Cognitive Impairment and Healthy Aging, run by i-Function, Inc. at 2 sites in United States.
Trial summary
People with cognitive impairments such as Mild Cognitive Impairment (MCI), often experience difficulty performing everyday routine activities. Further, normative age-related changes in cognition often lead to deficits on previously learned skills and impede new learning such as learning of new technology systems. Read more about this study
- Who is it for?
- Ages 60 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Healthy Aging
- What is being tested?
- The Computerized Functional Skills Assessment and Training Program and Brain HQ Double Decision
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2021to 31 May 2023
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 60 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English or Spanish speaking
- Able to read at the 6th grade level (WRAT)
- Able to read a computer screen and use a keyboard or mouse
- Has a willing and reliable informant
- Subjective memory complaints by the participant and/or collateral informant;
- Meets Jak Bondi criteria for the diagnosis of MCI.
- Score on the MOCA ≥ 26
Who cannot join
- Sensory Limitations
- MOCA <18
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ifunction at University of Miami
Miami, Florida, 33136
Weill Cornell Medical Center
New York, New York, 10021
About this study
Official title: : A Novel Computer-Based Functional Skills Assessment and Training Program
People with cognitive impairments such as Mild Cognitive Impairment (MCI), often experience difficulty performing everyday routine activities. Further, normative age-related changes in cognition often lead to deficits on previously learned skills and impede new learning such as learning of new technology systems. This is of great concern, given population aging, the increasing number of older adults with cognitive impairments, and the continual deployment of new technologies in everyday contexts. The objectives of this SBIR Phase II study is to build on a previous Phase I SBIR project and refine and further evaluate a novel integrated computer-based functional skills assessment and training (CFSAT) program that provides training on everyday tasks critical to independent living (e.g., financial and medication management) with non-impaired older adults (NC) and adults with MCI.
Read the detailed description
The CFSAT program provides training on everyday tasks critical to independent living (e.g., financial and medication management). The program currently includes six domain simulations critical to independent living: ATM Banking/Financial Management, Online Banking, Prescription Refill via Voice Menu, Kiosk Ticket Purchase, Online Shopping (and prescription refill), and Medication Management. The simulations are in a multi-media format and include graphic representations, voice and text. In the assessment component each of the six task domains includes subtasks that graduate in difficulty (e.g., check savings account balance, transfer money between accounts). The training component is designed to: 1) be consistent with adaptive training models of learning (tailored to the individual's skills); 2) adhere to current training guidelines for older adults, 3) identify the current levels of an individual's ability on the task with Item response theory strategies; 4) use dynamic-titration feedback from immediate task performance to adjust task difficulty to optimize training potential; and 5) provide immediate feedback and graduated instruction following errors, followed by repetition of the previously failed item. Performance metrics are captured in real time and include measures of accuracy and efficiency.
The proposed research will involve two phases and will be conducted at two locations: South Florida and New York City. Inclusion of two locations will allow us to expand the diversity of our sample and the generalizability of the findings across different regions of the U.S. Phase I will focus on validation of the 3rd alternative form of the fixed difficulty assessment tasks (form C); refinement of tasks to improve the graphical representations, enhance the difficulty level of the subtasks (based on findings from Phase 1), and ensure currency of the tasks; and usability testing of the refined tasks using a user-centered design approach. Data collection for Phase 1 will involve a sample of 24 older adults (8 non-impaired older adults aged 60+ (4 per site) and 16 with MCI aged 60+ (8 per site) (4 Spanish speaking in each group) and will take place in laboratory space at i-Function and a community location in NYC. The usability testing will occur on one day and involve approximately 2 hours. In Phase 1 the investigators will also develop browser-based version of the CFSAT program so that it can be launched from web browsers such as Google Chrome or Safari. This will greatly enhance the flexibility of the program, as the investigators will be able to launch the program from a variety of settings including the home. This is also a critical step for commercialization and direct to consumer sales.
Phase 2 will involve a multi-site trial to gather continued data on the efficacy of the CFSAT training with respect to functional gains and additional data on the usability, and acceptability of the program. The investigators will also gather data on: optimal training dosage; near and far transfer of training and environmental transfer of training (actual performance in the real world on the tasks trained by the program as tracked by the EMA protocol); the maintenance of training gains over time; the need for booster training; and adherence to home-based training protocols for those with MCI and non-impaired older adults (NC). In addition, the investigators will examine if computer-based cognitive training (CT) provides a priming effect that further enhances the benefits of the CFSAT training program for those with MCI.
- Conditions
- Mild Cognitive Impairment, Healthy Aging
- Being tested
- The Computerized Functional Skills Assessment and Training Program, Brain HQ Double Decision
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Computerized Functional Skills Assessment and Training ProgramDevice
The CFSAT program provides training on everyday tasks critical to independent living (e.g., financial and medication management). The program currently includes six domain simulations critical to independent living: ATM Banking/Financial Management, Online Banking, Prescription Refill via Voice Menu, Kiosk Ticket Purchase, Online Shopping (and prescription refill), and Medication Management.
Brain HQ Double DecisionDevice
Cognitive speed training program
| Study group | Role | What they receive |
|---|---|---|
| Healthy individuals Skills training only | Active comparator | These participants will receive CFSAT training only (n = 60). They will train for 24 hours over 12 weeks. Receives: Device: The Computerized Functional Skills Assessment and Training Program |
| MCI, Skills training only | Experimental | These participants will receive 24 hours of CFSAT training over 12 weeks following the same training protocol as the NC sample. Receives: Device: The Computerized Functional Skills Assessment and Training Program |
| MCI, Combined treatment | Experimental | Participants assigned to this condition will initially train for 3 weeks @ 60 minutes twice per week on CT (Posit Science). Participants will train 90 minutes on Double Decision and 30 minutes on Hawkeye. They can train on Hawkeye in 15- minute increments and intersperse it within the Double Decision training. They will then train CFSAT for 9 weeks at the recommended dosage. Each task will be trained twice before advancing to the next task Receives: Device: The Computerized Functional Skills Assessment and Training Program; Device: Brain HQ Double Decision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to completion on each Task of the the CFAST
Change in time to Completion time for each module
Measured: Change from Baseline to end of 12 weeks of training
Time to completion on each Task of the the CFAST
Change in time to Completion time for each module
Measured: Change from baseline to 3 months after the end of 12 weeks of training
Secondary outcomes (3)
Performance on the Brief Assessment of Cognition App
6-domain computerized cognitive assessments
Measured: Compared at baseline, after 12 weeks of training and 3 months after completion of training
Performance on The Virtual Reality Functional Capacity Assessment Task
Computerized Functional Capacity Measure
Measured: Compared at baseline, after 12 weeks of training and 3 months after completion of training
EMA measurement of real world activities
Participants will be surveyed as to their participation in several critical daily activities with EMA surveys
Measured: For 12 weeks of training and 3 months of followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start1 Aug 2021
- Primary completion30 Apr 2023
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Healthy individuals receive skills training only * MCI Participants are randomized to skills training only or skills training combined with computerized cognitive training
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- i-Function, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philip Harvey, PhD, Principal investigator, University of Miami/iFunction
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04679441
- Sponsor's protocol ID
- iFunction Phase 2
- Status last verified
- May 2023
- First submitted
- 11 Dec 2020
- Last updated
- 8 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: We are not planning on sharing IPD at this time as this is an SBIR
Publications
Harvey PD, Forero DB, Ahern LB, Tibirica L, Kallestrup P, Czaja SJ. The Computerized Functional Skills Assessment and Training Program: Sensitivity to Global Cognitive Impairment, Correlations With Cognitive Abilities, and Factor Structure. Am J Geriatr Psychiatry. 2021 Apr;29(4):395-404. doi: 10.1016/j.jagp.2020.08.019. Epub 2020 Sep 7.
PubMed 32980252Harvey PD, Tibirica L, Kallestrup P, Czaja SJ. A Computerized Functional Skills Assessment and Training Program Targeting Technology Based Everyday Functional Skills. J Vis Exp. 2020 Feb 13;(156):10.3791/60330. doi: 10.3791/60330.
PubMed 32116309Lin XY, Harvey PD, Kallestrup P, Czaja SJ. Maintenance of Technology-Based Functional Skills Training Gains in Older Participants With and Without Mild Cognitive Impairment: The Role of Booster Training. Am J Geriatr Psychiatry. 2026 Jan;34(1):31-40. doi: 10.1016/j.jagp.2025.09.019. Epub 2025 Sep 24.
PubMed 41111049
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- : A Novel Computer-Based Functional Skills Assessment and Training Program
- ClinicalTrials.gov ID
- NCT04679441
- Acronym / sponsor ID
- iFunction Phase 2
- Conditions
- Mild Cognitive Impairment, Healthy Aging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- i-Function, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 22 Dec 2020 (actual)
- 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.
People with cognitive impairments such as Mild Cognitive Impairment (MCI), often experience difficulty performing everyday routine activities. Further, normative age-related changes in cognition often lead to deficits on previously learned skills and impede new learning such as learning of new technology systems. This is of great concern, given population aging, the increasing number of older adults with cognitive impairments, and the continual deployment of new technologies in everyday contexts. The objectives of this SBIR Phase II study is to build on a previous Phase I SBIR project and refine and further evaluate a novel integrated computer-based functional skills assessment and training (CFSAT) program that provides training on everyday tasks critical to independent living (e.g., financial and medication management) with non-impaired older adults (NC) and adults with MCI.
Detailed description
The CFSAT program provides training on everyday tasks critical to independent living (e.g., financial and medication management). The program currently includes six domain simulations critical to independent living: ATM Banking/Financial Management, Online Banking, Prescription Refill via Voice Menu, Kiosk Ticket Purchase, Online Shopping (and prescription refill), and Medication Management. The simulations are in a multi-media format and include graphic representations, voice and text. In the assessment component each of the six task domains includes subtasks that graduate in difficulty (e.g., check savings account balance, transfer money between accounts). The training component is designed to: 1) be consistent with adaptive training models of learning (tailored to the individual's skills); 2) adhere to current training guidelines for older adults, 3) identify the current levels of an individual's ability on the task with Item response theory strategies; 4) use dynamic-titration feedback from immediate task performance to adjust task difficulty to optimize training potential; and 5) provide immediate feedback and graduated instruction following errors, followed by repetition of the previously failed item. Performance metrics are captured in real time and include measures of accuracy and efficiency.
The proposed research will involve two phases and will be conducted at two locations: South Florida and New York City. Inclusion of two locations will allow us to expand the diversity of our sample and the generalizability of the findings across different regions of the U.S. Phase I will focus on validation of the 3rd alternative form of the fixed difficulty assessment tasks (form C); refinement of tasks to improve the graphical representations, enhance the difficulty level of the subtasks (based on findings from Phase 1), and ensure currency of the tasks; and usability testing of the refined tasks using a user-centered design approach. Data collection for Phase 1 will involve a sample of 24 older adults (8 non-impaired older adults aged 60+ (4 per site) and 16 with MCI aged 60+ (8 per site) (4 Spanish speaking in each group) and will take place in laboratory space at i-Function and a community location in NYC. The usability testing will occur on one day and involve approximately 2 hours. In Phase 1 the investigators will also develop browser-based version of the CFSAT program so that it can be launched from web browsers such as Google Chrome or Safari. This will greatly enhance the flexibility of the program, as the investigators will be able to launch the program from a variety of settings including the home. This is also a critical step for commercialization and direct to consumer sales.
Phase 2 will involve a multi-site trial to gather continued data on the efficacy of the CFSAT training with respect to functional gains and additional data on the usability, and acceptability of the program. The investigators will also gather data on: optimal training dosage; near and far transfer of training and environmental transfer of training (actual performance in the real world on the tasks trained by the program as tracked by the EMA protocol); the maintenance of training gains over time; the need for booster training; and adherence to home-based training protocols for those with MCI and non-impaired older adults (NC). In addition, the investigators will examine if computer-based cognitive training (CT) provides a priming effect that further enhances the benefits of the CFSAT training program for those with MCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- * Healthy individuals receive skills training only * MCI Participants are randomized to skills training only or skills training combined with computerized cognitive training
| Arm | Type | Receives |
|---|---|---|
| Healthy individuals Skills training only | Active comparator | Device: The Computerized Functional Skills Assessment and Training ProgramThese participants will receive CFSAT training only (n = 60). They will train for 24 hours over 12 weeks. |
| MCI, Skills training only | Experimental | Device: The Computerized Functional Skills Assessment and Training ProgramThese participants will receive 24 hours of CFSAT training over 12 weeks following the same training protocol as the NC sample. |
| MCI, Combined treatment | Experimental | Device: The Computerized Functional Skills Assessment and Training Program, Device: Brain HQ Double DecisionParticipants assigned to this condition will initially train for 3 weeks @ 60 minutes twice per week on CT (Posit Science). Participants will train 90 minutes on Double Decision and 30 minutes on Hawkeye. They can train on Hawkeye in 15- minute increments and intersperse it within the Double Decision training. They will then train CFSAT for 9 weeks at the recommended dosage. Each task will be trained twice before advancing to the next task |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- English or Spanish speaking
- Able to read at the 6th grade level (WRAT)
- Able to read a computer screen and use a keyboard or mouse
- Has a willing and reliable informant
- Subjective memory complaints by the participant and/or collateral informant;
Key exclusion criteria (2 listed)
- Sensory Limitations
- MOCA <18
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 |
|---|---|---|
| The Computerized Functional Skills Assessment and Training ProgramThe CFSAT program provides training on everyday tasks critical to independent living (e.g., financial and medication management). The program currently includes six domain simulations critical to independent living: ATM Banking/Financial Management, Online Banking, Prescription Refill via Voice Menu, Kiosk Ticket Purchase, Online Shopping (and prescription refill), and Medication Management. | Device | Healthy individuals Skills training only, MCI, Combined treatment, MCI, Skills training only |
| Brain HQ Double DecisionCognitive speed training program | Device | MCI, Combined treatment |
Primary outcome
Time to completion on each Task of the the CFAST
Time frame: Change from Baseline to end of 12 weeks of training
Change in time to Completion time for each module
Time to completion on each Task of the the CFAST
Time frame: Change from baseline to 3 months after the end of 12 weeks of training
Change in time to Completion time for each module
3 secondary outcomes
Performance on the Brief Assessment of Cognition App
Time frame: Compared at baseline, after 12 weeks of training and 3 months after completion of training
Performance on The Virtual Reality Functional Capacity Assessment Task
Time frame: Compared at baseline, after 12 weeks of training and 3 months after completion of training
EMA measurement of real world activities
Time frame: For 12 weeks of training and 3 months of followup
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2023.
- Results publication: PubMed 32980252Harvey PD, Forero DB, Ahern LB, Tibirica L, Kallestrup P, Czaja SJ. The Computerized Functional Skills Assessment and Training Program: Sensitivity to Global Cognitive Impairment, Correlations With Cognitive Abilities, and Factor Structure. Am J Geriatr Psychiatry. 2021 Apr;29(4):395-404. doi: 10.1016/j.jagp.2020.08.019. Epub 2020 Sep 7.
- Results publication: PubMed 32116309Harvey PD, Tibirica L, Kallestrup P, Czaja SJ. A Computerized Functional Skills Assessment and Training Program Targeting Technology Based Everyday Functional Skills. J Vis Exp. 2020 Feb 13;(156):10.3791/60330. doi: 10.3791/60330.
- Derived from this study: PubMed 41111049Lin XY, Harvey PD, Kallestrup P, Czaja SJ. Maintenance of Technology-Based Functional Skills Training Gains in Older Participants With and Without Mild Cognitive Impairment: The Role of Booster Training. Am J Geriatr Psychiatry. 2026 Jan;34(1):31-40. doi: 10.1016/j.jagp.2025.09.019. Epub 2025 Sep 24.
- corporate websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. We are not planning on sharing IPD at this time as this is an SBIR
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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.
Philip Harvey, PhD principal investigator
University of Miami/iFunction
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing The Computerized Functional Skills Assessment and Training Program and Brain HQ Double Decision in people with Mild Cognitive Impairment and Healthy Aging, run by i-Function, Inc. at 2 sites in United States.
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 7 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: under way, not looking for participants, as of the sponsor's last update on 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Time to completion on each Task of the the CFAST (time frame: Change from Baseline to end of 12 weeks of training). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04679441, which also lists 3 linked publications.
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 8 May 2023.