跳至主要内容
临床试验/NCT03512301
NCT03512301已完成不适用

CAMCI: Advancing the Use of Computerized Screening in Healthcare

Psychology Software Tools, Inc.8 个研究点 分布在 1 个国家目标入组 773 人开始时间: 2019年8月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
773
试验地点
8
主要终点
Agreement Analysis (Agreement to Reference Standard) - Test Group

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
60 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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+

排除标准

  • 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
  • Montreal Cognitive Assessment (MoCA) score <10

结局指标

主要结局

Agreement Analysis (Agreement to Reference Standard) - Test Group

时间窗: baseline

Comparison (positive and negative percent agreement, confidence interval estimates, and quadratic weighted kappa) between CAMCI and clinical adjudication classifications for the Test group. Power calculations for agreement were assessed for Cohen Kappa's assuming at least 75% Normals with 80% power and .05 significance level, finding that we were sufficiently powered with at least 120 individuals in the test set, for a Kappa of at least 0.3.

Agreement Analysis (Agreement to Non-Reference Standard) - Test Group

时间窗: baseline

Linear regression agreement analysis (linear regression equation and confidence intervals, and Pearson correlation) between CAMCI and Montreal Cognitive Assessment (MoCA) for the Test group. Comparison (positive and negative percent agreement, confidence interval estimates, and quadratic weighted kappa) between CAMCI and Montreal Cognitive Assessment (MoCA) for the Test group. CAMCI Scores ranged from 0-50, higher scores mean better outcome. MoCA scores ranged from 0-30, higher scores mean better outcome. Power calculations for agreement were assessed for Cohen Kappa's assuming at least 75% Normals with 80% power and .05 significance level, finding that we were sufficiently powered with at least 120 individuals in the test set, for a Kappa of at least 0.3.

次要结局

未报告次要终点

研究者

发起方
Psychology Software Tools, Inc.
申办方类型
Industry
责任方
Principal Investigator
主要研究者

Amy Eschman

Grants Administration Manager

Psychology Software Tools, Inc.

研究点 (8)

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