Clinical trial NCT03158909: Trial of a Non-pharmacological Intervention to Prevent Delirium Among Elderly In-patients
Official title: Randomized Clinical Trial to Evaluate the Effect of a Non-pharmacological Intervention to Prevent Delirium Among Elderly In-patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Delirium
Keywords: Eyemask
Earplugs
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2017-05-18
Enrollment: 284
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incident cases of delirium.
timeFrame: Patients will be followed until diagnosis of delirium, death, discharge from hospital or transfer to another unit, up to 15 days from the inclusion in the study.
Secondary outcomes:
measure: Sleep quality
timeFrame: Daily as long the patient is still being followed, up to 15 days from the inclusion in the study.
measure: Safety of the intervention.
timeFrame: Daily as long the patient is still being followed, up to 15 days from the inclusion in the study.
measure: Acceptance, confort and adherence to the intervention.
timeFrame: After every night of eyemask and earplugs use, up to 15 days from the inclusion in the study.
measure: Use of psychotropic drugs.
timeFrame: Patients will be followed until diagnosis of delirium, death, discharge from hospital or transfer to another unit, up to 15 days from the inclusion in the study.
measure: Time of hospital stay.
timeFrame: Until hospital discharge, up to 6 months from inclusion in the study.
measure: Evaluation of the sleep-wake cycle.
timeFrame: Daily as long the patient is still being followed, up to 15 days from the inclusion in the study.
measure: Urinary 6-sulfatoxymelatonin levels.
timeFrame: 48 hours after admission (first urine of the day)
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Artur S Schuh, PhD
role: PRINCIPAL_INVESTIGATOR
References: