A Novel Computer-Based Functional Skills Assessment and Training Program

NCT ID: NCT04679441

Last Updated: 2023-05-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2023-05-31

Brief 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. 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.

Conditions

Mild Cognitive Impairment; Healthy Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Healthy individuals Skills training only

These participants will receive CFSAT training only (n = 60). They will train for 24 hours over 12 weeks.

Group Type: ACTIVE_COMPARATOR

The Computerized Functional Skills Assessment and Training Program

Intervention Type: DEVICE

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.

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.

Group Type: EXPERIMENTAL

The Computerized Functional Skills Assessment and Training Program

Intervention Type: DEVICE

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.

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

Group Type: EXPERIMENTAL

The Computerized Functional Skills Assessment and Training Program

Intervention Type: DEVICE

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 Decision

Intervention Type: DEVICE

Cognitive speed training program

Interventions

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.

Intervention Type: DEVICE

Brain HQ Double Decision

Cognitive speed training program

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Sensory Limitations
• MOCA <18

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

i-Function, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philip Harvey, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami/iFunction

Locations

Ifunction at University of Miami

Miami, Florida, United States

Weill Cornell Medical Center

New York, New York, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 32980252 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32116309 (View on PubMed)

Related Links

http://i-function.com

corporate website

Other Identifiers

iFunction Phase 2

Identifier Type: -

Identifier Source: org_study_id