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

Delirium Clinical Trial

Official title:

Randomized Clinical Trial to Evaluate the Effect of a Non-pharmacological Intervention to Prevent Delirium Among Elderly In-patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03158909
• Other study ID #: 160529
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2020
• Est. completion date: July 30, 2020

Study information

• Verified date: January 2020
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Artur S Schuh, PhD
• Phone: 55 51 3359-8520
• Email: schuh.afs[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 284
• Est. completion date: July 30, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Delirium

Intervention

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

Other:
• Orientation about space and time
Information and orientation about space and time, given every night.

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

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