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

Not Applicable

• Conditions: Delirium
• Interventions: Other: Orientation about space and time; Device: Eyemask and earplugs

• Registration Number: NCT03158909
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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.

Study Timeline

• Study First Submitted: 2017-05-11
• Study First Submitted QC: 2017-05-17
• Study First Posted: 2017-05-18
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-10
• Last Update Posted: 2020-01-14
• Study Start: 2020-01-15
• Primary Completion: 2020-05-31
• Study Completion: 2020-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 284

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Orientation about space and time	Orientation about space and time	This group will receive orientations about space and time olny, every night.
Interventional	Eyemask and earplugs	Patients in this group will receive eyemask and earplugs, for use during the night, and orientations about space and time, every night.
Interventional	Orientation about space and time	Patients in this group will receive eyemask and earplugs, for use during the night, and orientations about space and time, every night.

Primary Outcome Measures

Name	Time	Method
Incident cases of delirium.	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.	The short version of the Confusion Assessment Method (Short-CAM) will be used.

Secondary Outcome Measures

Name	Time	Method
Sleep quality	Daily as long the patient is still being followed, up to 15 days from the inclusion in the study.	A questionnaire composed of questions will be used.
Safety of the intervention.	Daily as long the patient is still being followed, up to 15 days from the inclusion in the study.	Record of adverse effects.
Acceptance, confort and adherence to the intervention.	After every night of eyemask and earplugs use, up to 15 days from the inclusion in the study.	A four questions questionnaire will be used.
Use of psychotropic drugs.	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.	Record of psychotropic drugs prescribed.
Time of hospital stay.	Until hospital discharge, up to 6 months from inclusion in the study.	The total time of hospital stay will be recorded.
Evaluation of the sleep-wake cycle.	Daily as long the patient is still being followed, up to 15 days from the inclusion in the study.	Actigraphy: A technique for assessing the sleep-wake cycle that allows the recording of motor activity through limb movements for 24 hours or more.
Urinary 6-sulfatoxymelatonin levels.	48 hours after admission (first urine of the day)	Urinary 6-sulfatoxymelatonin levels 48 hours after admission (first urine of the day).

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, Brazil