Prophylactic Environmental Management of Delirium (MAPDI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01356810
Recruitment Status : Completed
First Posted : May 20, 2011
Last Update Posted : May 23, 2011
Information provided by:
Universidad de Valparaiso

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.

Condition or disease Intervention/treatment Phase
Delirium Falls Other: Environmental Intervention Other: Standard Care Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 287 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Manejo Ambiental Profilactico Del Delirium Intrahospitalario
Study Start Date : September 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
Placebo Comparator: Standard Care
Delirium management defined by the attending physician.
Other: Standard Care
Delirium management by the attending physician's preferences.

Experimental: Environmental Intervention Other: Environmental Intervention
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.

Primary Outcome Measures :
  1. Incidence of Delirium [ Time Frame: Daily during the entire hospital stay (Average: 10 days, Maximum: 42 days) ]
    New episodes of delirium during the hospital stay

Secondary Outcome Measures :
  1. Incidence of Falls [ Time Frame: Daily during the entire hospital stay (Average: 10 days, Maximum: 42 days ]
    New episodes of Falls

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01356810

Hospital Naval Almirante Nef
Vina del Mar, Valparaiso, Chile
Sponsors and Collaborators
Universidad de Valparaiso
Principal Investigator: Felipe T Martinez, MD Universidad de Valparaiso

Responsible Party: Felipe Martinez Lomakin, Universidad de Valparaiso Identifier: NCT01356810     History of Changes
Other Study ID Numbers: P06/11
First Posted: May 20, 2011    Key Record Dates
Last Update Posted: May 23, 2011
Last Verified: August 2009

Keywords provided by Universidad de Valparaiso:
Primary Prevention

Additional relevant MeSH terms:
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders