CAMCI: Advancing the Use of Computerized Screening in Healthcare

• ClinicalTrials.gov Identifier: NCT03512301
• Recruitment Status: Recruiting
• First Posted: April 30, 2018
• Last Update Posted: August 3, 2022
• Sponsor: Psychology Software Tools, Inc.
• Collaborator: National Institute on Aging (NIA)
• Information provided by (Responsible Party): Amy Eschman, Psychology Software Tools, Inc.

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Cognitive Dysfunction; Cognitive Impairment; Cognitive Decline; Cognitive Change	Device: CAMCI	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 820 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: CAMCI: Advancing the Use of Computerized Screening in Healthcare
• Actual Study Start Date: August 8, 2019
• Estimated Primary Completion Date: May 31, 2023
• Estimated Study Completion Date: May 31, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: CAMCI Baseline Only; Computerized and paper-pencil neuropsychological tests, baseline	Device: CAMCI; CAMCI battery of computerized tasks; Other Name: 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 Name: CAMCI task battery

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Criterion validity correlation analysis [ Time Frame: baseline ]
   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.
2. Test/retest reliability [ Time Frame: 2-3 weeks ]
   Repeatability of CAMCI

Other Outcome Measures:

1. Measure of significant change [ Time Frame: baseline, 6 months, 12 months, 24 months post baseline ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 60 Years to 95 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Contacts

Contact: Michelle Fouse; 412-449-0078; michelle.fouse@pstnet.com

Contact: Amy Eschman; 412-449-0078; amy.eschman@pstnet.com

Locations

United States, Indiana

Indiana University; Active, not recruiting

Indianapolis, Indiana, United States, 46202

United States, Pennsylvania

Psychology Software Tools; Active, not recruiting

Sharpsburg, Pennsylvania, United States, 15215

United States, Texas

Baylor College of Medicine; Recruiting

Houston, Texas, United States, 77030

Contact: Adriana Strutt 713-798-8673 adrianam@bcm.edu

Contact: Donna Talavari donna.talavari@bcm.edu

Principal Investigator: Adriana Strutt, PhD

United States, Virginia

University of Virginia; Recruiting

Charlottesville, Virginia, United States, 22904

Contact: Lisa Opie 434-243-5143 RBO5N@hscmail.mcc.virginia.edu

Contact: Hillary Perez 434-924-0453 HYP8Q@hscmail.mcc.virginia.edu

Sub-Investigator: Carol Manning, PhD

Sponsors and Collaborators

Psychology Software Tools, Inc.

National Institute on Aging (NIA)

Investigators

• Principal Investigator: Amy Eschman; Psychology Software Tools

More Information

• Responsible Party: Amy Eschman, Grants Administration Manager, Psychology Software Tools, Inc.
• ClinicalTrials.gov Identifier: NCT03512301
• Other Study ID Numbers: 13; 2SB1AG037357-04A1 ( U.S. NIH Grant/Contract )
• First Posted: April 30, 2018
• Last Update Posted: August 3, 2022
• Last Verified: August 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

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.

• Supporting Materials: Study Protocol; Analytic Code

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.

• 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.

• 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
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders