Prophylactic Environmental Management of Delirium

NCT ID: NCT01356810

Last Updated: 2019-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 287 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2010-06-30

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.

Conditions

Delirium; Falls

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Standard Care

Delirium management defined by the attending physician.

Group Type: PLACEBO_COMPARATOR

Standard Care

Intervention Type: OTHER

Delirium management by the attending physician's preferences.

Environmental Intervention

Group Type: EXPERIMENTAL

Environmental Intervention

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Standard Care

Delirium management by the attending physician's preferences.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad de Valparaiso

OTHER

Sponsor Role: lead

Responsible Party

Felipe Martinez

Prophylactic Environmental Management of Delirium (MAPDI)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Felipe T Martinez, MD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Valparaiso

Locations

Hospital Naval Almirante Nef

Viña del Mar, Región de Valparaíso, Chile

Countries

Chile

Other Identifiers

P06/11

Identifier Type: -

Identifier Source: org_study_id