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Completed

NCT Number: NCT01356810

Prophylactic Environmental Management of Delirium

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.

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Naval Almirante Nef

Viña del Mar, Valparaiso, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Standard care

Other

Delirium management by the attending physician's preferences.

Primary outcomes

  1. 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

Secondary outcomes

  1. Incidence of Falls

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

    New episodes of Falls

Sponsors and collaborators

Lead sponsor

Universidad de Valparaiso

Other

Registry information

Official study title

Manejo Ambiental Profilactico Del Delirium Intrahospitalario

Acronym: MAPDI

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 20, 2011
Registry last updated
Jan 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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