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CAMCI: Advancing the Use of Computerized Screening in Healthcare

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ClinicalTrials.gov Identifier: NCT03512301
Recruitment Status : Recruiting
First Posted : April 30, 2018
Last Update Posted : August 26, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Amy Eschman, Psychology Software Tools, Inc.

Tracking Information
First Submitted Date  ICMJE April 17, 2018
First Posted Date  ICMJE April 30, 2018
Last Update Posted Date August 26, 2019
Actual Study Start Date  ICMJE August 8, 2019
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2018)
  • 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
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03512301 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2018)
  • 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.
  • Test/retest reliability [ Time Frame: 2-3 weeks ]
    Repeatability of CAMCI
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 27, 2018)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE CAMCI: Advancing the Use of Computerized Screening in Healthcare
Official Title  ICMJE CAMCI: Advancing the Use of Computerized Screening in Healthcare
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Cognitive Dysfunction
  • Cognitive Impairment
  • Cognitive Decline
  • Cognitive Change
Intervention  ICMJE Device: CAMCI
CAMCI battery of computerized tasks
Other Name: CAMCI task battery
Study Arms  ICMJE
  • Experimental: CAMCI Baseline Only
    Computerized and paper-pencil neuropsychological tests, baseline
    Intervention: Device: CAMCI
  • Experimental: CAMCI Baseline + Follow-Up
    Computerized and paper-pencil neuropsychological tests, Baseline + Follow-Up
    Intervention: Device: CAMCI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 27, 2018)
820
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2021
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Amy Eschman, MS 412-449-0078 ext 1463 info@pstnet.com
Contact: Grants Administration Manager 412-449-0078 info@pstnet.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03512301
Other Study ID Numbers  ICMJE 13
2SB1AG037357-04A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Supporting Materials: 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.
Responsible Party Amy Eschman, Psychology Software Tools, Inc.
Study Sponsor  ICMJE Psychology Software Tools, Inc.
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: Amy Eschman, MS Psychology Software Tools
PRS Account Psychology Software Tools, Inc.
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP