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

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ClinicalTrials.gov Identifier: NCT02109419
Recruitment Status : Completed
First Posted : April 9, 2014
Last Update Posted : January 18, 2016
Sponsor:
Information provided by (Responsible Party):
Corby K. Martin, Pennington Biomedical Research Center

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 LS. Development of computerized based assessments will significantly increase the scale, scope, and speed with which cognition, mood, and LS 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.


Condition or disease
Computerized Assessment Feasibility and Validity

Detailed Description:
See Brief Summary Section.

Study Type : Observational
Actual Enrollment : 57 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Feasibility and Validity of A Novel Computer Based Battery For Analysis of Cognition, Mood, and Mobility-Independence in the Elderly
Study Start Date : March 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Group/Cohort
Control
Mini Mental State Exam (MMSE) score 29-30; inclusive
Mild Cognitive Impairment
MMSE score 25-28; inclusive
Dementia
MMSE score 10-24; inclusive



Primary Outcome Measures :
  1. HHT Computerized Assessments [ Time Frame: participants will be assessed at visit 1 and visit 2, an expected average time enrolled in the study of 3 weeks ]
    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. This study will focus on quantifying the feasibility and validity of using HHT computerized assessments.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants will undergo screening to confirm eligibility, completion of initial screening form, and MMSE evaluation. Study subjects meeting study criteria will then be categorized as being in the control (MMSE 29-30: inclusive), mild cognitive impairment (MMSE 25-28: inclusive), or dementia (MMSE 10-24: inclusive) categories.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02109419


Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70806
Sponsors and Collaborators
Pennington Biomedical Research Center
Investigators
Principal Investigator: Corby K Martin, PhD Pennington Biomedical Research Center