CAMCI: Advancing the Use of Computerized Screening in Healthcare

Study Overview
=================
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.

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.

Official Title
-----------------
CAMCI: Advancing the Use of Computerized Screening in Healthcare

Conditions
-----------------
Cognitive Dysfunction, Cognitive Impairment, Cognitive Decline, Cognitive Change

Intervention / Treatment
-----------------
* Device: CAMCI


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 95 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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