MAPDI: Prophylactic Environmental Management of Delirium

Sponsor

Universidad de Valparaiso (Other)

Overall Status

Completed

CT.gov ID

NCT01356810

Collaborator

(none)

287

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Sep 1, 2009

Actual Primary Completion Date :

Jun 1, 2010

Actual Study Completion Date :

Jun 1, 2010

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Incidence of Delirium [Daily during the entire hospital stay (Average: 10 days, Maximum: 42 days)]
New episodes of delirium during the hospital stay

Secondary Outcome Measures

Incidence of Falls [Daily during the entire hospital stay (Average: 10 days, Maximum: 42 days]
New episodes of Falls

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Felipe Martinez, Prophylactic Environmental Management of Delirium (MAPDI), Universidad de Valparaiso

ClinicalTrials.gov Identifier:

NCT01356810

Other Study ID Numbers:

P06/11

First Posted:

May 20, 2011

Last Update Posted:

Jan 29, 2019

Last Verified:

Jan 1, 2019

Keywords provided by Felipe Martinez, Prophylactic Environmental Management of Delirium (MAPDI), Universidad de Valparaiso

Delirium

Primary Prevention

Elderly

Additional relevant MeSH terms:

Delirium

Study Results

No Results Posted as of Jan 29, 2019