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A Novel Computer-Based Functional Skills Assessment and Training Program

Primary Purpose

Mild Cognitive Impairment, Healthy Aging

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
The Computerized Functional Skills Assessment and Training Program
Brain HQ Double Decision
Sponsored by
i-Function, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment

Eligibility Criteria

60 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ifunction at University of Miami
  • Weill Cornell Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Healthy individuals Skills training only

MCI, Skills training only

MCI, Combined treatment

Arm Description

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

These participants will receive 24 hours of CFSAT training over 12 weeks following the same training protocol as the NC sample.

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

Outcomes

Primary Outcome Measures

Time to completion on each Task of the the CFAST
Change in time to Completion time for each module
Time to completion on each Task of the the CFAST
Change in time to Completion time for each module

Secondary Outcome Measures

Performance on the Brief Assessment of Cognition App
6-domain computerized cognitive assessments
Performance on The Virtual Reality Functional Capacity Assessment Task
Computerized Functional Capacity Measure
EMA measurement of real world activities
Participants will be surveyed as to their participation in several critical daily activities with EMA surveys

Full Information

First Posted
December 11, 2020
Last Updated
May 5, 2023
Sponsor
i-Function, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04679441
Brief Title
A Novel Computer-Based Functional Skills Assessment and Training Program
Official Title
: A Novel Computer-Based Functional Skills Assessment and Training Program
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
May 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
i-Function, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Healthy Aging

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Healthy individuals receive skills training only MCI Participants are randomized to skills training only or skills training combined with computerized cognitive training
Masking
Outcomes Assessor
Masking Description
Outcomes data wil be collected in an automated manner and will be entered directly into a database
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy individuals Skills training only
Arm Type
Active Comparator
Arm Description
These participants will receive CFSAT training only (n = 60). They will train for 24 hours over 12 weeks.
Arm Title
MCI, Skills training only
Arm Type
Experimental
Arm Description
These participants will receive 24 hours of CFSAT training over 12 weeks following the same training protocol as the NC sample.
Arm Title
MCI, Combined treatment
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
The Computerized Functional Skills Assessment and Training Program
Intervention 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.
Intervention Type
Device
Intervention Name(s)
Brain HQ Double Decision
Intervention Description
Cognitive speed training program
Primary Outcome Measure Information:
Title
Time to completion on each Task of the the CFAST
Description
Change in time to Completion time for each module
Time Frame
Change from Baseline to end of 12 weeks of training
Title
Time to completion on each Task of the the CFAST
Description
Change in time to Completion time for each module
Time Frame
Change from baseline to 3 months after the end of 12 weeks of training
Secondary Outcome Measure Information:
Title
Performance on the Brief Assessment of Cognition App
Description
6-domain computerized cognitive assessments
Time Frame
Compared at baseline, after 12 weeks of training and 3 months after completion of training
Title
Performance on The Virtual Reality Functional Capacity Assessment Task
Description
Computerized Functional Capacity Measure
Time Frame
Compared at baseline, after 12 weeks of training and 3 months after completion of training
Title
EMA measurement of real world activities
Description
Participants will be surveyed as to their participation in several critical daily activities with EMA surveys
Time Frame
For 12 weeks of training and 3 months of followup

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Self-representation
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Harvey, PhD
Organizational Affiliation
University of Miami/iFunction
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ifunction at University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We are not planning on sharing IPD at this time as this is an SBIR
Citations:
PubMed Identifier
32980252
Citation
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.
Results Reference
result
PubMed Identifier
32116309
Citation
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.
Results Reference
result
Links:
URL
http://i-function.com
Description
corporate website

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A Novel Computer-Based Functional Skills Assessment and Training Program

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