Computerized Assessment Feasibility and Validity
Conditions
Keywords
computerized assessments, mood, cognition
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.
Detailed description
See Brief Summary Section.
Interventions
OTHERHHT-G
Helping Hands Technology global cognitive function assessment
OTHERHHT-D
Helping Hands Technology depression assessment
OTHERGeriatric Depression Scale (DGS)
Geriatric Depression Scale (DGS)
OTHERMMSE
Mini Mental State Exam
Sponsors
Pennington Biomedical Research Center
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reliability and Validity of HHT's Computerized Assessments as Assessed by Correlation Analysis. | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants All participants, inclusive of those with no memory impairment, mild cognitive impairment, and dementia. | 57 |
| Total | 57 |
Baseline characteristics
| Characteristic | All Participants | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 45 Participants | — |
| Age, Categorical Between 18 and 65 years | 12 Participants | — |
| Age, Continuous | 71.7 years STANDARD_DEVIATION 6 | — |
| Geriatric Depression Scale (GDS) | 1 units on a scale STANDARD_DEVIATION 1.5 | — |
| Mini Mental State Questionnaire (MMSE) | 28 units on a scale STANDARD_DEVIATION 2.9 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 57 Participants | — |
| Sex: Female, Male Female | 35 Participants | — |
| Sex: Female, Male Male | 22 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 24 | 0 / 8 |
| other Total, other adverse events | 0 / 25 | 0 / 24 | 0 / 8 |
| serious Total, serious adverse events | 0 / 25 | 0 / 24 | 0 / 8 |
Outcome results
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).
Time frame: Visit completed over 16 day period
Population: Males and females between the ages of 60 and 85 years, inclusive, with MMSE scores of 10-30, inclusive.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Reliability and Validity of HHT's Computerized Assessments as Assessed by Correlation Analysis. | HHT-D Time 1/baseline | 11 Units on a scale | Standard Deviation 3.7 |
| All Participants | Reliability and Validity of HHT's Computerized Assessments as Assessed by Correlation Analysis. | HHT-D Time 2, up to 16 days later | 11 Units on a scale | Standard Deviation 3.6 |
| All Participants | Reliability and Validity of HHT's Computerized Assessments as Assessed by Correlation Analysis. | HHT-G Time 1/baseline | 25 Units on a scale | Standard Deviation 3 |
| All Participants | Reliability and Validity of HHT's Computerized Assessments as Assessed by Correlation Analysis. | HHT-G Time 2, up to 16 days later | 25 Units on a scale | Standard Deviation 3.5 |
Comparison: HHT-D reliability was evaluated via test-retest reliability coefficients. The dataset included participants from all groups.p-value: <0.0001Pearson Test-retest reliability coeff.
Comparison: HHT-G reliability was evaluated via test-retest reliability coefficients. The dataset included participants from all groups.p-value: <0.0001Pearson test-retest reliability coeff
Comparison: Validity of the HHT-D was tested by Pearson correlation coefficients between HHT-D and Geriatric Depression Scale (GDS) scores. The dataset included participants from all groups.p-value: <0.0001Pearson correlation coefficient
Comparison: Validity of the HHT-G was tested by Pearson correlation coefficients between HHT-G and Mini-Mental State Examination (MMSE) scores. The dataset included participants from all groups.p-value: 0.0001Pearson correlation coefficient
Comparison: Internal consistency reliability of the HHT-D was assessed with Chronbach's alpha. The dataset included participants from all groups.
Comparison: Internal consistency reliability of the HHT-G was assessed with Chronbach's alpha. The dataset included participants from all groups.