Feasibility and Validity of A Novel Computer Based Battery of Assessments in the Elderly

Overview

While standard pencil-and-paper test have continued to be useful for the monitoring of cognition, mood, and life space (LS) in the elderly they do have considerable limitations. Use of these pencil-and-paper tests requires that individuals come to the clinic for assessments, which results in significant clinical costs and practical limitations in the conducting of assessments in large numbers of individuals, and provides a time consuming and non-automated means of quantifying and recording changes in brain function. It is increasingly recognized that there is a need to develop valid and reliable computer based assessments to allow for the remote assessment of cognition, mood, and other parameters. Development of computerized based assessments will significantly increase the scale, scope, and speed with which cognition and mood can be measured in the elderly.

Helping Hands Technology LLC (HHT) has developed a number of web based assessments of cognition, mood, and LS. These new computerized assessments will be developed using new technology, and are based on the general principles found in existing pencil-and-paper based assessments of cognition, mood, and LS. In addition, HHT is developing proprietary means of reporting the results of the computerized assessments in an easy to use narrative format. This study will focus on quantifying the feasibility and validity of using HHT computerized assessments.

Full Title of Study: “Feasibility and Validity of A Novel Computer Based Battery For Analysis of Cognition, Mood, and Mobility-Independence in the Elderly”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 2014

Detailed Description

See Brief Summary Section.

Interventions

  • Other: HHT-G
    • Helping Hands Technology global cognitive function assessment
  • Other: HHT-D
    • Helping Hands Technology depression assessment
  • Other: Geriatric Depression Scale (DGS)
    • Geriatric Depression Scale (DGS)
  • Other: MMSE
    • Mini Mental State Exam

Arms, Groups and Cohorts

  • All participants
    • All participants, including control, mild cognitive impairment, and dementia.

Clinical Trial Outcome Measures

Primary Measures

  • Reliability and Validity of HHT’s Computerized Assessments as Assessed by Correlation Analysis.
    • Time Frame: Visit completed over 16 day period
    • Assess the reliability, validity and internal consistency of the HHT-D (Helping Hands Depression Test; min and max score is 0 and 30, respectively; higher scores reflect higher depression) and the HHT-G (Helping Hands global cognitive function screener; min and max scores are 0 and 30, respectively; higher scores reflect better cognition). In addition to assessing reliability, the HHT scales’ validity was examined by correlating scores on the HHT scales with existing and already validated pen-and-paper assessments, which included the Mini-Mental State Exam (MMSE; min and max scores are 0 and 30, higher scores reflect better cognitive functioning), and the Geriatric Depression Scale (GDS; min and max scores are 0 and 15, respectively; higher scores reflect higher depression).

Participating in This Clinical Trial

Inclusion Criteria

  • Men and woman between the ages of 60-85, inclusive
  • Cognitive function/impairment within appropriate ranges for the study (Mini-Mental State Exam scores of 10-30, inclusive)

Exclusion Criteria

  • Unable to complete computerized and standard pencil-and-paper based assessments

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Pennington Biomedical Research Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Corby K. Martin, Principal Investigator – Pennington Biomedical Research Center
  • Overall Official(s)
    • Corby K Martin, PhD, Principal Investigator, Pennington Biomedical Research Center

References

Brouillette RM, Foil H, Fontenot S, Correro A, Allen R, Martin CK, Bruce-Keller AJ, Keller JN. Feasibility, reliability, and validity of a smartphone based application for the assessment of cognitive function in the elderly. PLoS One. 2013 Jun 11;8(6):e65925. doi: 10.1371/journal.pone.0065925. Print 2013.

Maerlender A, Flashman L, Kessler A, Kumbhani S, Greenwald R, Tosteson T, McAllister T. Examination of the construct validity of ImPACTâ„¢ computerized test, traditional, and experimental neuropsychological measures. Clin Neuropsychol. 2010 Nov;24(8):1309-25. doi: 10.1080/13854046.2010.516072. Epub 2010 Oct 4.

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