Clinical trial NCT01555996: Early Occupational Therapy for Delirium Prevention in Older Patients Admitted to Critical Care Unit
Official title: Early Occupational Therapy (OT) for Delirium Prevention in Older Patients Admitted to Critical Care Unit (CCU)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium
Alteration of Cognitive Function
Incompetence, Functional
Keywords: older
delirium
cognitive status
occupational therapy
critically ill patients
Lead sponsor: University of Chile
Sponsor class: OTHER
Collaborators: name: Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
name: National Fund for Research and Development in Health, Chile
First posted: 2012-03-16
Enrollment: 126
Sex: ALL
Minimum age (years): 60
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized, controlled trial to compare the efficacy of two strategies of non-pharmacological prevention of delirium in critically non-ventilated older patients:

* standard non-pharmacological prevention
* intensive nonpharmacological prevention (standard non-pharmacological prevention plus early and intensive occupational therapy).

Detailed description: Delirium is a complication in older, with incidences 70-87% in CCU. This increases mortality, hospital stay, hospital cost, and cognitive impairment. Occupational Therapy (OT) improves independence at discharge, and reduction in delirium in patients undergoing mechanical ventilation. This study compares the efficacy of non pharmacological standard prevention (control group) versus intensive nonpharmacological prevention (experimental group) in the delirium duration in older admitted CCU.

Eligibility criteria: Inclusion Criteria:

* Age over 60 years.
* Admission to CCU for monitoring by acute or chronic illness, expected more than 24 hours
* Informed consent of patient or family related.

Exclusion Criteria:

* Cognitive impairment before to admission (measured by Test Reporter-TIN).
* Severe disorder of communication and cultural constraint of language (inhability of properly communicating in Spanish)
* Delirium at CCU admission or at the beginning of the intervention
* Need for mechanical ventilation
* Early limitation of therapeutic efforts and greater comorbidity with expected mortality within 90 days (in the opinion of the treating team).

Primary outcomes:
measure: To evaluate Delirium duration
timeFrame: From second until sixth days hospitalization
Secondary outcomes:
measure: Delirium incidence
timeFrame: From second until sixth days hospitalization
measure: Functional independence
timeFrame: To seventh day of hospitalization and 72 hours before discharge
measure: Strenght of Grip evaluation
timeFrame: To seventh day of hospitalization and 72 hours before discharge
measure: Cognitive State
timeFrame: To seventh day of hospitalization and 72 hours before discharge
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Clinico Universidad de Chile
state: RM
Study officials:
affiliation: University of Chile
name: Evelyn Alvarez
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chile
name: Maricel Garrido
role: STUDY_CHAIR
affiliation: University of Chile
name: Eduardo Tobar
role: STUDY_CHAIR
affiliation: University of Chile
name: Rolando Aranda
role: STUDY_CHAIR
References: