Reliability and Equivalence of Alternate Forms of the Digital Clock Drawing Test

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-18

Study Completion Date

2021-11-16

Brief Summary

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Equivalence of DCTclock-pen and DCTclock-tablet will be tested in a randomized crossover trial.

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Detailed Description

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Randomized crossover trial consisting of two test visits separated by a washout period of 3 to 5 weeks. Subjects are randomized into two equal groups. Group 1 receives the digital pen (DCTclock-pen) version of the test at the first visit, with the tablet version (DCTclock-tablet) given at the second visit; Group 2 receives DCTclock-tablet at the first visit, followed by DCTclock-pen at the second visit. At Visit 1 (day 0), eligibility is assessed and a version of the DCTclock test is administered based on the group allocation. A battery of Linus Platform tests and reference standard tests are also administered. At visit 2 (day 21-35), eligibility is assessed and the alternate version of the DCTclock test is administered based on the group allocation. A battery of Linus Platform tests is also administered, together with reference standard tests. Equivalence of DCTclock-pen and DCTclock-tablet will be tested. Linus Platform test data will also be collected to develop novel measures of cognitive and motor function and assess their accuracy in detecting impairment, construct validity, and test-retest reliability.

Conditions

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Cognitive Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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DCTclock-pen first

DCTclock-pen followed by DCTclock-tablet

Group Type EXPERIMENTAL

DCTclock

Intervention Type DEVICE

Cognitive Test

DCTclock-tablet first

DCTclock-tablet followed by DCTclock-pen

Group Type EXPERIMENTAL

DCTclock

Intervention Type DEVICE

Cognitive Test

Interventions

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DCTclock

Cognitive Test

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 55-95 years old

Exclusion Criteria

* Ineligible for written informed consent
* Impairment of the writing hand that precludes ability to perform the study tasks
* Impaired manual dexterity in the writing hand
* Impaired vision in both eyes
* Under the influence of recreational drugs or alcohol at the time of the visit.
* Current or recent participation in a clinical trial that includes the use of a drug or intervention to alter cognitive function.
* Recent (within the last 6 months) cognitive testing with a Clock Drawing Test.
* Visit 2 Only- Self-reported change (addition or discontinuation) of the following medications between visit 1 and visit 2; Timolol (eye drop), Benadryl, beta blockers, steroids or over the counter medications for sleep (PM varieties).

Minimum Eligible Age

55 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes