Computerized Assessment Feasibility and ValidityHHTNCT02109419

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

An observational study of Computerized Assessment Feasibility and Validity, run by Pennington Biomedical Research Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 60 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Computerized Assessment Feasibility and Validity
What is being tested?: HHT-G, HHT-D and Geriatric Depression Scale (DGS)
How many people: 57 participants
Where: 1 siteUnited States
Study dates: Mar 2014to Oct 2014
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

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).

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70806

Other trials in United States

About this study

Official title: Feasibility and Validity of A Novel Computer Based Battery For Analysis of Cognition, Mood, and Mobility-Independence in the Elderly

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.

Read the detailed description

See Brief Summary Section.

Conditions: Computerized Assessment Feasibility and Validity
Being tested: HHT-G, HHT-D, Geriatric Depression Scale (DGS), MMSE
Keywords: computerized assessments, mood, cognition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HHT-GOther
Helping Hands Technology global cognitive function assessment
HHT-DOther
Helping Hands Technology depression assessment
Geriatric Depression Scale (DGS)Other
Geriatric Depression Scale (DGS)
MMSEOther
Mini Mental State Exam

Study groups in NCT02109419
Study group	Role	What they receive
All participants		All participants, including control, mild cognitive impairment, and dementia. Receives: Other: HHT-G; Other: HHT-D; Other: Geriatric Depression Scale (DGS); Other: MMSE

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Visit completed over 16 day period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2014Oct 2014

First posted9 Apr 2014 (estimated)
Study startMar 2014
Primary completionSep 2014
Study completionOct 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Computerized Assessment Feasibility and ValidityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02109419
Sponsor's protocol ID: PBRC 2013-040
Acronym: HHT
Status last verified: Aug 2019
First submitted: 21 Jan 2014
Last updated: 6 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 23776570
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.
PubMed 20924979

Study at a glance

From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility and Validity of A Novel Computer Based Battery For Analysis of Cognition, Mood, and Mobility-Independence in the Elderly
ClinicalTrials.gov ID: NCT02109419
Acronym / sponsor ID: HHT / PBRC 2013-040
Conditions: Computerized Assessment Feasibility and Validity
Keywords: computerized assessments, mood, cognition
Study type: Observational
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: Pennington Biomedical Research CenterUniversity, hospital or other
Study start: Mar 2014
Primary completion: Sep 2014 (actual)
Study completion: Oct 2014 (actual)
First posted: 9 Apr 2014 (estimated)
Results: Posted 6 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

See Brief Summary Section.

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
All participants	–	Other: HHT-G, Other: HHT-D, Other: Geriatric Depression Scale (DGS), Other: MMSEAll participants, including control, mild cognitive impairment, and dementia.

Who may qualify

Ages: 60 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
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).

Key inclusion criteria (2 listed)

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)

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HHT-GHelping Hands Technology global cognitive function assessment	Other	All participants
HHT-DHelping Hands Technology depression assessment	Other	All participants
Geriatric Depression Scale (DGS)Geriatric Depression Scale (DGS)	Other	All participants
MMSEMini Mental State Exam	Other	All participants

Primary outcome

Reliability and Validity of HHT's Computerized Assessments as Assessed by Correlation Analysis.
Time frame: 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).

Results and safety

Results posted to the registry on 6 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	57	57

Primary outcome: Reliability and Validity of HHT's Computerized Assessments as Assessed by Correlation Analysis.

Time frame: Visit completed over 16 day period. Mean (Standard Deviation). Unit: Units on a scale

Measure	All Participants n = 57
HHT-D Time 1/baseline	11 (3.7)
HHT-D Time 2, up to 16 days later	11 (3.6)
HHT-G Time 1/baseline	25 (3.0)
HHT-G Time 2, up to 16 days later	25 (3.5)

All Participants: Pearson Test-retest reliability coeff.: 0.80, p <0.0001, Pearson Test-retest reliability coeff.
All Participants: Pearson test-retest reliability coeff: 0.87, p <0.0001, Pearson test-retest reliability coeff
All Participants: Pearson correlation coefficient: 0.60, p <.0001, Pearson correlation coefficient

Population analysed: Males and females between the ages of 60 and 85 years, inclusive, with MMSE scores of 10-30, inclusive.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	0 of 25 (0%)	0 of 25 (0%)	0 of 25
Mild Cognitive Impairment	0 of 24 (0%)	0 of 24 (0%)	0 of 24
Dementia	0 of 8 (0%)	0 of 8 (0%)	0 of 8

Limitations and caveats (from the sponsor): Test-retest reliability evaluated by administering the same battery at both time points in the study, hence learning effects were possible.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23776570Brouillette 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.
Background: PubMed 20924979Maerlender 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.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Corby K Martin, PhD principal investigator

Pennington Biomedical Research Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Computerized Assessment Feasibility and Validity, run by Pennington Biomedical Research Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reliability and Validity of HHT's Computerized Assessments as Assessed by Correlation Analysis. (time frame: Visit completed over 16 day period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02109419, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019; AzTrials last refreshed its copy on 26 Oct 2026.