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

NCT02109419 | Completed Results

• 1 other identifier: PBRC 2013-040
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Computerized Assessment Feasibility and Validity

Keywords

computerized assessments; mood; cognition

Outcome Measures

Primary Outcomes (1)

• Reliability and Validity of HHT's Computerized Assessments as Assessed by Correlation Analysis.

  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

Study Arms (1)

All participants

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

Other: HHT-G; Other: HHT-D; Other: Geriatric Depression Scale (DGS); Other: MMSE

Interventions

HHT-G OTHER

Helping Hands Technology global cognitive function assessment

All participants

HHT-D OTHER

Helping Hands Technology depression assessment

All participants

Geriatric Depression Scale (DGS) OTHER

Geriatric Depression Scale (DGS)

All participants

MMSE OTHER

Mini Mental State Exam

All participants

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70806, United States

Location

Related Publications (2)

• 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.

  PMID: 23776570 BACKGROUND

• Maerlender A, Flashman L, Kessler A, Kumbhani S, Greenwald R, Tosteson T, McAllister T. Examination of the construct validity of ImPACT 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.

  PMID: 20924979 BACKGROUND

Limitations and Caveats

Test-retest reliability evaluated by administering the same battery at both time points in the study, hence learning effects were possible.

Results Point of Contact

• Title: Dr. Corby K. Martin
• Organization: Pennington Biomedical Research Center

corby.martin@pbrc.edu

225-763-2585

Study Officials

• Corby K Martin, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 21, 2014
• First Posted: April 9, 2014
• Study Start: March 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: September 6, 2019
• Results First Posted: September 6, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)