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Active, not recruiting Phase 2

A Novel Computer-Based Functional Skills Assessment and Training Program

NCT04679441 · tracked via the Priya Life Science USA tracker
Sponsor
i-Function, Inc
Phase
Phase 2
Started
2021-08-01
Last updated
2023-05-08

Condition(s) studied

Mild Cognitive ImpairmentHealthy Aging

Investigational drug(s) / intervention(s)

The Computerized Functional Skills Assessment and Training ProgramBrain HQ Double Decision

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.

Brain HQ Double Decision: Cognitive speed training program

Study 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.

Eligibility

Sex
ALL
Min age
60 Years
Max age
100 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

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

Trial sites (2)

FacilityCityRegionStatus
Ifunction at University of Miami Miami Florida
Weill Cornell Medical Center New York New York
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04679441 on ClinicalTrials.gov ↗ ← All trials in the USA