Trial of a Non-pharmacological Intervention to Prevent Delirium Among Elderly In-patients
Primary Purpose
Delirium
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Eyemask and earplugs
Orientation about space and time
Sponsored by
About this trial
This is an interventional prevention trial for Delirium focused on measuring Eyemask, Earplugs
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.
Sites / Locations
- Hospital de Clínicas de Porto AlegreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Interventional
Orientation about space and time
Arm Description
Patients in this group will receive eyemask and earplugs, for use during the night, and orientations about space and time, every night.
This group will receive orientations about space and time olny, every night.
Outcomes
Primary Outcome Measures
Incident cases of delirium.
The short version of the Confusion Assessment Method (Short-CAM) will be used.
Secondary Outcome Measures
Sleep quality
A questionnaire composed of questions will be used.
Safety of the intervention.
Record of adverse effects.
Acceptance, confort and adherence to the intervention.
A four questions questionnaire will be used.
Use of psychotropic drugs.
Record of psychotropic drugs prescribed.
Time of hospital stay.
The total time of hospital stay will be recorded.
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.
Urinary 6-sulfatoxymelatonin levels.
Urinary 6-sulfatoxymelatonin levels 48 hours after admission (first urine of the day).
Full Information
NCT ID
NCT03158909
First Posted
May 11, 2017
Last Updated
January 10, 2020
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT03158909
Brief Title
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
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2020 (Anticipated)
Primary Completion Date
May 31, 2020 (Anticipated)
Study Completion Date
July 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium
Keywords
Eyemask, Earplugs
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
284 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interventional
Arm Type
Experimental
Arm Description
Patients in this group will receive eyemask and earplugs, for use during the night, and orientations about space and time, every night.
Arm Title
Orientation about space and time
Arm Type
Active Comparator
Arm Description
This group will receive orientations about space and time olny, every night.
Intervention Type
Device
Intervention Name(s)
Eyemask and earplugs
Intervention Description
Eyemask and earplugs for use during the night, to improve sleep.
Intervention Type
Other
Intervention Name(s)
Orientation about space and time
Intervention Description
Information and orientation about space and time, given every night.
Primary Outcome Measure Information:
Title
Incident cases of delirium.
Description
The short version of the Confusion Assessment Method (Short-CAM) will be used.
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.
Secondary Outcome Measure Information:
Title
Sleep quality
Description
A questionnaire composed of questions will be used.
Time Frame
Daily as long the patient is still being followed, up to 15 days from the inclusion in the study.
Title
Safety of the intervention.
Description
Record of adverse effects.
Time Frame
Daily as long the patient is still being followed, up to 15 days from the inclusion in the study.
Title
Acceptance, confort and adherence to the intervention.
Description
A four questions questionnaire will be used.
Time Frame
After every night of eyemask and earplugs use, up to 15 days from the inclusion in the study.
Title
Use of psychotropic drugs.
Description
Record of psychotropic drugs prescribed.
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.
Title
Time of hospital stay.
Description
The total time of hospital stay will be recorded.
Time Frame
Until hospital discharge, up to 6 months from inclusion in the study.
Title
Evaluation of the sleep-wake cycle.
Description
Actigraphy: A technique for assessing the sleep-wake cycle that allows the recording of motor activity through limb movements for 24 hours or more.
Time Frame
Daily as long the patient is still being followed, up to 15 days from the inclusion in the study.
Title
Urinary 6-sulfatoxymelatonin levels.
Description
Urinary 6-sulfatoxymelatonin levels 48 hours after admission (first urine of the day).
Time Frame
48 hours after admission (first urine of the day)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Artur S Schuh, PhD
Phone
55 51 3359-8520
Email
schuh.afs@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Andressa H Hermes-Pereira, Master
Phone
55 51 3359-8520
Email
andressahpereira@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Artur S Schuh, PhD
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90035903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andressa H Pereira, CP
Phone
5551997957558
Email
andressahpereira@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Trial of a Non-pharmacological Intervention to Prevent Delirium Among Elderly In-patients
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