A Novel Computer-Based Functional Skills Assessment and Training Program

NCT04679441 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2023-05-08

No results posted yet for this 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.

Conditions

Interventions

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

Sponsors & Collaborators

  • i-Function, Inc.

    lead INDUSTRY

Principal Investigators

  • Philip Harvey, PhD · University of Miami/iFunction

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2023-04-30
Completion
2023-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04679441 on ClinicalTrials.gov