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

August 31, 2019 updated by: Corby K. Martin, Pennington Biomedical Research Center

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

See Brief Summary Section.

Study Type

Observational

Enrollment (Actual)

57

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70806
        • Pennington Biomedical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants will undergo screening to confirm eligibility, completion of initial screening form, and MMSE evaluation. Study subjects were enrolled with MMSE scores between 29-30, inclusive (healthy/control), 25-28, inclusive (mild cognitive impairment), and 10-24 (dementia).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All participants
All participants, including control, mild cognitive impairment, and dementia.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Visit completed over 16 day period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pennington Biomedical Research Center

Investigators

  • Principal Investigator: Corby K Martin, PhD, Pennington Biomedical Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

January 21, 2014

First Submitted That Met QC Criteria

April 4, 2014

First Posted (Estimate)

April 9, 2014

Study Record Updates

Last Update Posted (Actual)

September 6, 2019

Last Update Submitted That Met QC Criteria

August 31, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PBRC 2013-040

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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