Trial Outcomes & Findings for Feasibility and Validity of A Novel Computer Based Battery of Assessments in the Elderly (NCT NCT02109419)

NCT ID: NCT02109419

Last Updated: 2019-09-06

Results Overview

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).

• Recruitment status: COMPLETED
• Target enrollment: 57 participants
• Primary outcome timeframe: Visit completed over 16 day period
• Results posted on: 2019-09-06

Participant Flow

Participant milestones

Measure	All Participants All participants, including control, mild cognitive impairment (MCI), and dementia.
Overall Study STARTED	57
Overall Study COMPLETED	57
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	All Participants n=57 Participants All participants, inclusive of those with no memory impairment, mild cognitive impairment, and dementia.
Age, Categorical <=18 years	0 Participants n=57 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=57 Participants
Age, Categorical >=65 years	45 Participants n=57 Participants
Age, Continuous	71.7 years STANDARD_DEVIATION 6.0 • n=57 Participants
Sex: Female, Male Female	35 Participants n=57 Participants
Sex: Female, Male Male	22 Participants n=57 Participants
Region of Enrollment United States	57 Participants n=57 Participants
Geriatric Depression Scale (GDS)	1 units on a scale STANDARD_DEVIATION 1.5 • n=57 Participants
Mini Mental State Questionnaire (MMSE)	28 units on a scale STANDARD_DEVIATION 2.9 • n=57 Participants

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	All Participants n=57 Participants All participants, including those with no memory impairment, mild cognitive impairment, and dementia.
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
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 3.0
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
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

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mild Cognitive Impairment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dementia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Corby K. Martin

Pennington Biomedical Research Center

Phone: 225-763-2585

Email: corby.martin@pbrc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place