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NCT Number: NCT02109419

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

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.

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Key information

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70806, United States

About this study

See Brief Summary Section.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HHT-G

Other

Helping Hands Technology global cognitive function assessment

HHT-D

Other

Helping Hands Technology depression assessment

Geriatric Depression Scale (DGS)

Other

Geriatric Depression Scale (DGS)

MMSE

Other

Mini Mental State Exam

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Official study title

Feasibility and Validity of A Novel Computer Based Battery For Analysis of Cognition, Mood, and Mobility-Independence in the Elderly

Acronym: HHT

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 9, 2014
Registry last updated
Sep 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.