A Novel Computer-Based Functional Skills Assessment and Training Program

: 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy Aging; Mild Cognitive Impairment
• Intervention / Treatment: Device: The Computerized Functional Skills Assessment and Training Program; Device: Brain HQ Double Decision

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 Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Ifunction at University of Miami
  • New York
    • New York, New York, United States, 10021
      • Weill Cornell Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria MCI:

• 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.

Inclusion Criteria HC:

• Score on the MOCA ≥ 26

Exclusion Criteria:

• Sensory Limitations
• MOCA <18

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Healthy individuals Skills training only; These participants will receive CFSAT training only (n = 60). They will train for 24 hours over 12 weeks.	Device: The Computerized Functional Skills Assessment and Training Program; 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.
Experimental: MCI, Skills training only; These participants will receive 24 hours of CFSAT training over 12 weeks following the same training protocol as the NC sample.	Device: The Computerized Functional Skills Assessment and Training Program; 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.
Experimental: MCI, Combined treatment; 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	Device: The Computerized Functional Skills Assessment and Training Program; 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.; Device: Brain HQ Double Decision; Cognitive speed training program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to completion on each Task of the the CFAST	Change in time to Completion time for each module	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	Change from baseline to 3 months after the end of 12 weeks of training

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance on the Brief Assessment of Cognition App	6-domain computerized cognitive assessments	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	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	For 12 weeks of training and 3 months of followup

Collaborators and Investigators

• Sponsor: i-Function, Inc.
• Investigators: Principal Investigator: Philip Harvey, PhD, University of Miami/iFunction

Publications and helpful links

General 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.
• Harvey 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.

Helpful Links

• corporate website

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): April 30, 2023
• Study Completion (Anticipated): May 31, 2023

Study Registration Dates

• First Submitted: December 11, 2020
• First Submitted That Met QC Criteria: December 16, 2020
• First Posted (Actual): December 22, 2020

Study Record Updates

• Last Update Posted (Actual): May 8, 2023
• Last Update Submitted That Met QC Criteria: May 5, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: iFunction Phase 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We are not planning on sharing IPD at this time as this is an SBIR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes