A Novel Computer-Based Functional Skills Assessment and Training Program

NCT04679441 | Active Not Recruiting Phase 2 DMC FDA Device

• 1 other identifier: iFunction Phase 2
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

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.

Conditions

Mild Cognitive Impairment; Healthy Aging

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Performance on the Brief Assessment of Cognition App

  Compared at baseline, after 12 weeks of training and 3 months after completion of training

• Performance on The Virtual Reality Functional Capacity Assessment Task

  Compared at baseline, after 12 weeks of training and 3 months after completion of training

• EMA measurement of real world activities

  For 12 weeks of training and 3 months of followup

Study Arms (3)

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.

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.

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

Device: The Computerized Functional Skills Assessment and Training Program; Device: Brain HQ Double Decision

Interventions

The Computerized Functional Skills Assessment and Training Program 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.

Healthy individuals Skills training only; MCI, Combined treatment; MCI, Skills training only

Brain HQ Double Decision DEVICE

Cognitive speed training program

MCI, Combined treatment

Eligibility Criteria

• Age: 60 Years - 100 Years
• Gender Eligibility Details: Self-representation
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Sensory Limitations
• MOCA \<18

Sponsors & Collaborators

• i-Function, Inc.: lead

Study Sites (2)

Ifunction at University of Miami

Miami, Florida, 33136, United States

Location

Weill Cornell Medical Center

New York, New York, 10021, United States

Location

Related Publications (2)

• 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.

  PMID: 32980252 RESULT

• 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.

  PMID: 32116309 RESULT

Related Links

• corporate website

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Philip Harvey, PhD

  University of Miami/iFunction

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes data wil be collected in an automated manner and will be entered directly into a database
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: * Healthy individuals receive skills training only * MCI Participants are randomized to skills training only or skills training combined with computerized cognitive training

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 22, 2020
• Study Start: August 1, 2021
• Primary Completion: April 30, 2023
• Study Completion: May 31, 2023
• Last Updated: May 8, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)