Back to resultsProphylactic Environmental Management of Delirium (MAPDI)
Primary Purpose
Delirium, Falls
Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Environmental Intervention
Standard Care
Sponsored by
About this trial
This is an interventional prevention trial for Delirium focused on measuring Delirium, Primary Prevention, Elderly
Eligibility Criteria
Inclusion Criteria:
- Above 65 years of age and one of the following:
- Age above 70 years.
- Alcoholism
- Cognitive deficit (Mini mental state examination <24 points)
- Metabolic disturbance (Hyponatremia, Hypernatremia, Hyperkalemia, Hypokalemia Hyperglycemia or Hypoglycemia)
Exclusion Criteria:
- Delirium at admission.
- Admittance to a ward other than general internal medicine.
- Lack of family support.
- Informed consent refusal.
- Hospitalization in a room with more than two beds.
Sites / Locations
- Hospital Naval Almirante Nef
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Standard Care
Environmental Intervention
Arm Description
Delirium management defined by the attending physician.
Outcomes
Primary Outcome Measures
Incidence of Delirium
New episodes of delirium during the hospital stay
Secondary Outcome Measures
Incidence of Falls
New episodes of Falls
Full Information
NCT ID
NCT01356810
First Posted
May 16, 2011
Last Updated
January 25, 2019
Sponsor
Universidad de Valparaiso
1. Study Identification
Unique Protocol Identification Number
NCT01356810
Brief Title
Prophylactic Environmental Management of Delirium
Acronym
MAPDI
Official Title
Manejo Ambiental Profilactico Del Delirium Intrahospitalario
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Valparaiso
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Delirium is a complex neuropsychiatric syndrome with an acute onset and fluctuating course which is presented in 15 to 20% of patients admitted to general wards. It is a potentially life - threatening complication which can be prevented. It is the objective of this randomized controlled trial to evaluate whether a multicomponent environmental intervention could reduce the incidence of delirium in a general medical ward.
Detailed Description
A total of 287 patients 65 years of age or older who had been admitted to a general medicine ward and who were at risk of delirium were studied. Eligible patients were randomized to a multicomponent environmental intervention or standard care. Both groups were well balanced in patients characteristics and followed during the full hospital stay by a group trained in the application of the confusion assessment method to detect incident delirium.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Falls
Keywords
Delirium, Primary Prevention, Elderly
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
287 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Care
Arm Type
Placebo Comparator
Arm Description
Delirium management defined by the attending physician.
Arm Title
Environmental Intervention
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Environmental Intervention
Intervention Description
The environmental intervention consisted of daily reorientation, avoidance of sensorial deprivation, longer visiting hours, the availability of a clock, a calendar and the presence of familiar objects in the room.
Intervention Type
Other
Intervention Name(s)
Standard Care
Intervention Description
Delirium management by the attending physician's preferences.
Primary Outcome Measure Information:
Title
Incidence of Delirium
Description
New episodes of delirium during the hospital stay
Time Frame
Daily during the entire hospital stay (Average: 10 days, Maximum: 42 days)
Secondary Outcome Measure Information:
Title
Incidence of Falls
Description
New episodes of Falls
Time Frame
Daily during the entire hospital stay (Average: 10 days, Maximum: 42 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Above 65 years of age and one of the following:
Age above 70 years.
Alcoholism
Cognitive deficit (Mini mental state examination <24 points)
Metabolic disturbance (Hyponatremia, Hypernatremia, Hyperkalemia, Hypokalemia Hyperglycemia or Hypoglycemia)
Exclusion Criteria:
Delirium at admission.
Admittance to a ward other than general internal medicine.
Lack of family support.
Informed consent refusal.
Hospitalization in a room with more than two beds.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felipe T Martinez, MD
Organizational Affiliation
Universidad de Valparaiso
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Naval Almirante Nef
City
Vina del Mar
State/Province
Valparaiso
Country
Chile
12. IPD Sharing Statement
Learn more about this trial
Prophylactic Environmental Management of Delirium
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