Prophylactic Environmental Management of Delirium (MAPDI)

This study has been completed.
Sponsor:
Information provided by:
Universidad de Valparaiso
ClinicalTrials.gov Identifier:
NCT01356810
First received: May 16, 2011
Last updated: May 20, 2011
Last verified: August 2009
  Purpose

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 Intervention
Delirium
Falls
Other: Environmental Intervention
Other: Standard Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Manejo Ambiental Profilactico Del Delirium Intrahospitalario

Resource links provided by NLM:


Further study details as provided by Universidad de Valparaiso:

Primary Outcome Measures:
  • Incidence of Delirium [ Time Frame: Daily during the entire hospital stay (Average: 10 days, Maximum: 42 days) ] [ Designated as safety issue: No ]
    New episodes of delirium during the hospital stay


Secondary Outcome Measures:
  • Incidence of Falls [ Time Frame: Daily during the entire hospital stay (Average: 10 days, Maximum: 42 days ] [ Designated as safety issue: No ]
    New episodes of Falls


Enrollment: 287
Study Start Date: September 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01356810

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

No publications provided

Responsible Party: Felipe Martinez Lomakin, Universidad de Valparaiso
ClinicalTrials.gov Identifier: NCT01356810     History of Changes
Other Study ID Numbers: P06/11
Study First Received: May 16, 2011
Last Updated: May 20, 2011
Health Authority: Chile: Institutional Review Board

Keywords provided by Universidad de Valparaiso:
Delirium
Primary Prevention
Elderly

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014