Early Occupational Therapy for Delirium Prevention in Older Patients Admitted to Critical Care Unit

Not Applicable

Completed

• Conditions: Alteration of Cognitive Function; Delirium; Incompetence, Functional
• Interventions: Behavioral: Early and Intensive Occupational Therapy; Behavioral: Standard non-pharmacological delirium prevention

• Registration Number: NCT01555996
• Lead Sponsor: University of Chile

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.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2012-01-10
• Study First Submitted QC: 2012-03-15
• Study First Posted: 2012-03-16
• Primary Completion: 2012-07
• Study Completion: 2012-12
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-19
• Last Update Posted: 2014-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early and intensive OT	Early and Intensive Occupational Therapy	-
Standard non-pharmacological prevention	Standard non-pharmacological delirium prevention	-

Primary Outcome Measures

Name	Time	Method
To evaluate Delirium duration	From second until sixth days hospitalization	Twice a day evaluation for delirium with CAM instrument, for 5 days from enrollment

Secondary Outcome Measures

Name	Time	Method
Delirium incidence	From second until sixth days hospitalization	Proportion of patients in each arm, to developed delirium during daily evaluation
Functional independence	To seventh day of hospitalization and 72 hours before discharge	Comparing performance of Activity Daily Living (ADL) at hospital discharge compared to baseline, using FIM (Functional Independence Measure) instrument
Strenght of Grip evaluation	To seventh day of hospitalization and 72 hours before discharge	Strength of grip by Jamar Dynamometer, is evaluated to hospitalary discharge
Cognitive State	To seventh day of hospitalization and 72 hours before discharge	MMSE (Mini-Mental State Examination), evaluates cognitive state at hospital discharge

Trial Locations

Locations (1)

Hospital Clinico Universidad de Chile; 🇨🇱 Santiago, RM, Chile