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

January 10, 2020 updated by: Hospital de Clinicas de Porto Alegre

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

284

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Porto Alegre, Brazil, 90035903
        • Recruiting
        • Hospital de Clinicas de Porto Alegre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional
Patients in this group will receive eyemask and earplugs, for use during the night, and orientations about space and time, every night.
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.
Active Comparator: Orientation about space and time
This group will receive orientations about space and time olny, every night.
Other: Orientation about space and time
Information and orientation about space and time, given every night.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incident cases of delirium.
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep quality
Time Frame: 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.
Daily as long the patient is still being followed, up to 15 days from the inclusion in the study.
Safety of the intervention.
Time Frame: Daily as long the patient is still being followed, up to 15 days from the inclusion in the study.
Record of adverse effects.
Daily as long the patient is still being followed, up to 15 days from the inclusion in the study.
Acceptance, confort and adherence to the intervention.
Time Frame: 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.
After every night of eyemask and earplugs use, up to 15 days from the inclusion in the study.
Use of psychotropic drugs.
Time Frame: 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.
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.
Time of hospital stay.
Time Frame: Until hospital discharge, up to 6 months from inclusion in the study.
The total time of hospital stay will be recorded.
Until hospital discharge, up to 6 months from inclusion in the study.
Evaluation of the sleep-wake cycle.
Time Frame: 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.
Daily as long the patient is still being followed, up to 15 days from the inclusion in the study.
Urinary 6-sulfatoxymelatonin levels.
Time Frame: 48 hours after admission (first urine of the day)
Urinary 6-sulfatoxymelatonin levels 48 hours after admission (first urine of the day).
48 hours after admission (first urine of the day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Artur S Schuh, PhD, Hospital de Clinicas de Porto Alegre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 15, 2020

Primary Completion (Anticipated)

May 31, 2020

Study Completion (Anticipated)

July 30, 2020

Study Registration Dates

First Submitted

May 11, 2017

First Submitted That Met QC Criteria

May 17, 2017

First Posted (Actual)

May 18, 2017

Study Record Updates

Last Update Posted (Actual)

January 14, 2020

Last Update Submitted That Met QC Criteria

January 10, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 160529

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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