CAMCI: Advancing the Use of Computerized Screening in Healthcare

Cognitive impairment is a significant health problem in the United States, resulting in costs over $100 billion a year. We will provide an efficient, effective, and financially intelligent solution to Primary Care Physician's to identify cognitive impairment in the earliest stages, delay progression through appropriate treatment, and to afford patients the opportunity to make future plans at a time when symptoms are mild and patients are able to make informed decisions concerning financial and life activities. This has the potential to delay devastating effects of cognitive impairment, and to lessen the financial burden on the health care system in the United States.

Study Overview

• Status: Completed
• Conditions: Cognitive Impairment; Cognitive Dysfunction; Cognitive Change; Cognitive Decline
• Intervention / Treatment: Device: CAMCI

Detailed Description

Cognitive dysfunction in the elderly population, ranging from simple forgetfulness to a diagnosis of Alzheimer's disease, can impact one's quality of life and ability to function in daily activities. It is crucial that decline be detected as early as possible in order to evaluate whether the cause is treatable, and to employ appropriate treatment, if applicable. The majority of older patients rely on their primary care physician for the bulk of their healthcare needs, but there is a lack of sensitive tools available, and there is a lack of physician's time to use the tools, leading to a failure to provide therapeutic intervention at the earliest stages of loss to potentially slow the progression of disease. Psychology Software Tools, Inc. (PST) has developed the Computer Assessment of Memory and Cognitive Impairment (CAMCI), a computerized screening tool for detection of early signs of cognitive decline, which has been shown to be more effective in the identification of patients with subtle cognitive loss than the tools most frequently used within the primary care physician (PCP) office. CAMCI would provide an option for PCPs and clinicians to provide therapeutic intervention prior to a diagnosis of dementia. Recent additions to Current Procedural Terminology (CPT) codes permit insurance reimbursement for neuropsychological testing by a computer, including time for the physician's or clinical psychologist's interpretation and reporting. The introduction of this new revenue stream for PCPs and clinicians, coupled with the characteristics of being brief and self-administered make CAMCI an attractive option for improving early intervention, providing an intelligent business solution for healthcare professionals, and a useful and effective tool that allows physicians to better evaluate and serve their patients. The specific aims included in the current project focus on activities required to successfully move CAMCI to commercialization by extending support for late stage research and product development, including regulatory strategy and intellectual property development, data collection to replicate key studies, product extension through increasing minority representation, and development of a measure of meaningful change. The ultimate goal is to streamline commercialization of CAMCI, and to provide a useful and effective tool in the detection of cognitive dysfunction to physicians, the providers of the majority of healthcare to the elderly population, to improve efficiency and effectiveness of clinical practice.

• Study Type: Interventional
• Enrollment (Actual): 773
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michelle Fouse; Phone Number: 412-449-0078; Email: michelle.fouse@pstnet.com
• Study Contact Backup: Name: Amy Eschman; Phone Number: 412-449-0078; Email: amy.eschman@pstnet.com

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Pennsylvania
    • Sharpsburg, Pennsylvania, United States, 15215
      • Psychology Software Tools
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
  • Virginia
    • Charlottesville, Virginia, United States, 22904
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 58 years to 93 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Signed informed consent
• Adequate visual and auditory acuity to allow neuropsychological testing
• Able to read, write and understand study and test requirements
• Within the age range of 60+

Exclusion Criteria:

• Significant neurologic disease, such as multi-infarct dementia, Parkinson's disease, epilepsy, stroke, multiple sclerosis or head trauma
• History of major depression or other major psychiatric disorder, such as, schizophrenia and bipolar disorder
• History of consuming 5 or more alcoholic drinks per day on a regular basis
• MoCA score <10

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CAMCI Baseline Only; Computerized and paper-pencil neuropsychological tests, baseline	Device: CAMCI; CAMCI battery of computerized tasks; Other Names: CAMCI task battery
Experimental: CAMCI Baseline + Follow-Up; Computerized and paper-pencil neuropsychological tests, Baseline + Follow-Up	Device: CAMCI; CAMCI battery of computerized tasks; Other Names: CAMCI task battery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement to reference standard	Comparison (positive and negative percent agreement, confidence interval estimates, and quadratic weighted kappa) between CAMCI classifications and clinical adjudication classifications	baseline
Agreement to non-reference standard	Linear regression agreement analysis (scatterplot, linear regression equation and confidence intervals, and Pearson correlation) between CAMCI score and Montreal Cognitive Assessment (MoCA) score.	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Criterion validity correlation analysis	Analysis of correlations between CAMCI accuracy measures (i.e., accuracy of responses within individual tasks) and individual paper and pencil neuropsychological tests (i.e., scores achieved on individual tests) to assess both convergent (high correlations with related measures) and divergent (lower correlations with measures that should not be related) validity.	baseline
Test/retest reliability	Repeatability of CAMCI	2-3 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of significant change	To develop a measure of significant change, we will compare overall CAMCI scores (calculated as the sum of the individual task scores) to expected scores (based on age and education) across repeated assessments (baseline, and 6,12, and 24 months from baseline) using a Reliable Change Index (RCI) method, as well as within-subject standard deviation using a one-way analysis of variance model.	baseline, 6 months, 12 months, 24 months post baseline

Collaborators and Investigators

• Sponsor: Psychology Software Tools, Inc.
• Collaborators: National Institute on Aging (NIA)
• Investigators: Study Director: Anthony Zuccolotto, Psychology Software Tools

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2019
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: April 17, 2018
• First Submitted That Met QC Criteria: April 27, 2018
• First Posted (Actual): April 30, 2018

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 13; 2SB1AG037357-04A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Quality-controlled raw data as well as processed data used in publications will be made available. Shared data will include computerized task scores, neuropsychological test scores, and full analytical codes used to process and analyze the data. Workflows will be described and documented to allow replication of results from the raw data.

Data and corresponding documentation will be made available through Open Science Framework (https://osf.io/), in addition to any potential requirements on software sharing by journals.

The PI or Co-Investigators will disseminate results from this research through presentations at public lectures, scientific institutions and meetings, and/or publication in major journals. The PI and Co-Investigators will adhere to the NIH Grants Policy on Sharing of Unique Research Resources including the Sharing of Biomedical Research Resources: Guidelines for Recipients of NIH Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources.

IPD Sharing Time Frame

Data will be deposited into the repository indicated above as soon as possible, but no later than 4 years after the end of the award project period.

The Small Business Act provides authority for NIH to protect from disclosure and nongovernmental use all Small Business Innovative Research (SBIR) data developed from work performed under an SBIR funding agreement for a period of 4 years after the closeout of either a phase I or phase II grant unless NIH obtains permission from the awardee to disclose these data. The data rights protection period lapses only upon expiration of the protection period applicable to the SBIR award, or by agreement between the small business concern and NIH.

• IPD Sharing Access Criteria: PST will identify where the data will be available and how to access the data in any publications and presentations about these data, as well as acknowledge the repository and funding source in any publications and presentations. In addition, PST will abide by the policies and procedures required by the repository indicated above, fully consistent with NIH data sharing policies and applicable laws and regulations.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No