Prophylactic Environmental Management of Delirium (MAPDI)

January 25, 2019 updated by: Felipe Martinez, Universidad de Valparaiso

Manejo Ambiental Profilactico Del Delirium Intrahospitalario

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

287

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

  • Chile
    • Valparaiso
      • Vina del Mar, Valparaiso, Chile
        • Hospital Naval Almirante Nef

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Daily during the entire hospital stay (Average: 10 days, Maximum: 42 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Falls
Time Frame: Daily during the entire hospital stay (Average: 10 days, Maximum: 42 days
New episodes of Falls
Daily during the entire hospital stay (Average: 10 days, Maximum: 42 days

Collaborators and Investigators

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

Sponsor

Universidad de Valparaiso

Investigators

  • Principal Investigator: Felipe T Martinez, MD, Universidad de Valparaiso

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

September 1, 2009

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

May 16, 2011

First Submitted That Met QC Criteria

May 17, 2011

First Posted (Estimate)

May 20, 2011

Study Record Updates

Last Update Posted (Actual)

January 29, 2019

Last Update Submitted That Met QC Criteria

January 25, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P06/11

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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