Trial of a Non-pharmacological Intervention to Prevent Delirium Among Elderly In-patients

NCT ID: NCT03158909

Last Updated: 2020-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

284 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-15

Study Completion Date

2020-07-30

Brief Summary

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This study evaluates the effect of earplugs and eyemask for delirium prevention among elderly in-patients. Half of patients will receive earplugs and eyemask for use during the night and information about orientation to time and space every night, while the other half will receive only the time and space orientations.

Detailed Description

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Delirium is an acute neuropsychiatric syndrome usually associated with a general medical condition. Its prevalence is high among hospitalized elderly patients and is generally underdiagnosed. Delirium is associated with prolonged hospitalization, increased mortality, institutionalization, falls, cognitive and functional decline and also with higher economic costs. The etiology of delirium is multifactorial, including excessive sensorial stimulation and disruption of the sleep-wake cycle as triggering factors.

The aim of this study is evaluate the effect of earplugs and eyemask for delirium prevention among elderly in-patients of a brazilian university hospital. This will be a partially blinded clinical trial, in wich both control and intervention group will receive information about orientation to time and space every evening, and intervention group will also receive earplugs and eyemask for use during the night. The primary outcome will be the occurrence of delirium.

Conditions

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Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Interventional

Patients in this group will receive eyemask and earplugs, for use during the night, and orientations about space and time, every night.

Group Type EXPERIMENTAL

Eyemask and earplugs

Intervention Type DEVICE

Eyemask and earplugs for use during the night, to improve sleep.

Orientation about space and time

Intervention Type OTHER

Information and orientation about space and time, given every night.

Orientation about space and time

This group will receive orientations about space and time olny, every night.

Group Type ACTIVE_COMPARATOR

Orientation about space and time

Intervention Type OTHER

Information and orientation about space and time, given every night.

Interventions

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Eyemask and earplugs

Eyemask and earplugs for use during the night, to improve sleep.

Intervention Type DEVICE

Orientation about space and time

Information and orientation about space and time, given every night.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* In-patients, expected to stay for at least 24 hours.
* Understand and consent in participating in the study and sign the consent form.
* 60 years of age, or older.
* Visual and auditory acuity sufficient to perform cognitive tests.

Exclusion Criteria

* Diagnosis of delirium in the selection visit.
* Glasgow Coma Scale less than 15 in the selection visit.
* PRISMA-7 ≤3 patient will be excluded.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Artur S Schuh, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clínicas de Porto Alegre

Locations

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Hospital de Clínicas de Porto Alegre

Porto Alegre, , Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Artur S Schuh, PhD

Role: CONTACT

55 51 3359-8520

Andressa H Hermes-Pereira, Master

Role: CONTACT

55 51 3359-8520

Facility Contacts

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Andressa H Pereira, CP

Role: primary

5551997957558

Other Identifiers

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160529

Identifier Type: -

Identifier Source: org_study_id

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