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NCT02617056 · ClinicalTrials.gov registry record

Objective Assessment of Behavioral Associations of Patients With Dementia

A clinical trial, sponsored by VA Office of Research and Development.

Completed
Registry status
21
Enrollment target

NCT02617056: Completed study, sponsored by VA Office of Research and Development.

NCT02617056 is a clinical trial that has completed, run by VA Office of Research and Development. The registered enrollment target is 21 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02617056 has completed, sponsored by VA Office of Research and Development.

COMPLETED
Registry status
21 participants
Enrollment target

Study Summary

It is generally acknowledged that patients with dementia are best cared for at home. However, outbursts of various behavioral disturbances, e.g., combativeness, appear in most cases and often necessitate institutionalization. These outbursts are often without apparent warning, which limits preventive interventions. The measurement of the electrical activity of the skin is well-studied as an indicator of stress or agitation. The investigators propose to monitor the electrical activity of skin in patients with dementia in order to determine whether any sign of agitation may occur before the outburst. If skin electrical activity gives sufficient warning, then preventive interventions may be tried. If successful, the ability to predict and prevent outbursts of behavioral disturbances will allow patients to be cared for at home for longer periods. It is the primary aim of this project to determine whether skin electrical activity gives such a warning; possible preventive measures will be the subject of future studies.

Primary Outcome

The purpose of this trial is to determine whether a signal of electrodermal activity (EDA) will precede an outburst of a behavioral disturbance by enough time to permit an intervention to prevent that behavior. This is a pilot project to test this hypothesis; subsequent studies will test the effectiveness of interventions. Therefore, the primary outcome sought is the detection of such a signal. EDA includes skin potential and skin conductivity. The time course of these two measurements form elec

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2016-01-01
Est. Completion 2025-09-30
VA Office of Research and Development

1,668 total trials

What the finished NCT02617056 record still lists

NCT02617056 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 21 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT02617056 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02617056 about?

NCT02617056 is a clinical study titled "Objective Assessment of Behavioral Associations of Patients With Dementia". It is generally acknowledged that patients with dementia are best cared for at home. However, outbursts of various behavioral disturbances, e.g., combativeness, appear in most cases and often necessitate institutionalization. These outbursts are often without apparent warning, which limits preventiv...

What is the current status of trial NCT02617056?

This trial is currently completed. The enrollment target is 21 participants. The study started on 2016-01-01. Estimated completion is 2025-09-30.

Who is sponsoring clinical trial NCT02617056?

This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT02617056, the US trial registry maintained by the National Library of Medicine. NCT02617056 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.