Prophylactic Environmental Management of Delirium

NCT01356810 | Completed

• 1 other identifier: P06/11
• Study Type: interventional
• Target: 287
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium; Falls

Keywords

Delirium; Primary Prevention; Elderly

Outcome Measures

Primary Outcomes (1)

• Incidence of Delirium

  New episodes of delirium during the hospital stay

  Daily during the entire hospital stay (Average: 10 days, Maximum: 42 days)

Secondary Outcomes (1)

• Incidence of Falls

  Daily during the entire hospital stay (Average: 10 days, Maximum: 42 days

Study Arms (2)

Standard Care

PLACEBO COMPARATOR

Delirium management defined by the attending physician.

Other: Standard Care

Environmental Intervention

EXPERIMENTAL

Other: Environmental Intervention

Interventions

Environmental Intervention 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.

Environmental Intervention

Standard Care OTHER

Delirium management by the attending physician's preferences.

Standard Care

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Valparaiso: lead

Study Sites (1)

Hospital Naval Almirante Nef

Viña del Mar, Región de Valparaíso, Chile

Location

MeSH Terms

Conditions

Delirium

Interventions

Milieu Therapy; Standard of Care

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Felipe T Martinez, MD

  Universidad de Valparaiso

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prophylactic Environmental Management of Delirium (MAPDI)

Study Record Dates

• First Submitted: May 16, 2011
• First Posted: May 20, 2011
• Study Start: September 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: January 29, 2019

Record last verified: 2019-01

Locations

CL (1)