Prophylactic Environmental Management of Delirium

Delirium Clinical Trial

— MAPDI  

Official title:

Manejo Ambiental Profilactico Del Delirium Intrahospitalario

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01356810
• Other study ID #: P06/11
• Status: Completed
• Phase: N/A
• Start date: September 2009
• Est. completion date: June 2010

Study information

• Verified date: January 2019
• Source: Universidad de Valparaiso
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 287
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Delirium
• Falls

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.
• Standard Care
Delirium management by the attending physician's preferences.

Locations

Country	Name	City	State
Chile	Hospital Naval Almirante Nef	Vina del Mar	Valparaiso

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Valparaiso

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Delirium	New episodes of delirium during the hospital stay	Daily during the entire hospital stay (Average: 10 days, Maximum: 42 days)
Secondary	Incidence of Falls	New episodes of Falls	Daily during the entire hospital stay (Average: 10 days, Maximum: 42 days