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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.
See Brief Summary Section.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | All participants, including control, mild cognitive impairment, and dementia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HHT-G | Other | Helping Hands Technology global cognitive function assessment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Corby K Martin, PhD | Pennington Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70806 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23776570 | Background | 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. | |
| 20924979 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | All participants, including control, mild cognitive impairment (MCI), and dementia. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants, inclusive of those with no memory impairment, mild cognitive impairment, and dementia. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Males and females between the ages of 60 and 85 years, inclusive, with MMSE scores of 10-30, inclusive. | Posted | Mean | Standard Deviation | Units on a scale | Visit completed over 16 day period |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Mini Mental State Exam (MMSE) score 29-30; inclusive | 0 |
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Test-retest reliability evaluated by administering the same battery at both time points in the study, hence learning effects were possible.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Corby K. Martin | Pennington Biomedical Research Center | 225-763-2585 | corby.martin@pbrc.edu |
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| HHT-D |
| Other |
Helping Hands Technology depression assessment |
|
| Geriatric Depression Scale (DGS) | Other | Geriatric Depression Scale (DGS) |
|
| MMSE | Other | Mini Mental State Exam |
|
| 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. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Geriatric Depression Scale (GDS) | Geriatric Depression Scale (GDS; min and max scores are 0 and 15, respectively; higher scores reflect higher depression). | Mean | Standard Deviation | units on a scale |
|
| Mini Mental State Questionnaire (MMSE) | Mini-Mental State Exam (MMSE; min and max scores are 0 and 30, higher scores reflect better cognitive functioning). | Mean | Standard Deviation | units on a scale |
|
| OG000 |
| All Participants |
All participants, including those with no memory impairment, mild cognitive impairment, and dementia. |
|
|
|
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Mild Cognitive Impairment | MMSE score 25-28; inclusive | 0 | 24 | 0 | 24 | 0 | 24 |
| EG002 | Dementia | MMSE score 10-24; inclusive | 0 | 8 | 0 | 8 | 0 | 8 |
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