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

Primary Purpose

Delirium, Alteration of Cognitive Function, Incompetence, Functional

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Early and Intensive Occupational Therapy
Standard non-pharmacological delirium prevention
Sponsored by
University of Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delirium focused on measuring older, delirium, cognitive status, occupational therapy, critically ill patients

Eligibility Criteria

60 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Hospital Clinico Universidad de Chile

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early and intensive OT

Standard non-pharmacological prevention

Arm Description

Outcomes

Primary Outcome Measures

To evaluate Delirium duration
Twice a day evaluation for delirium with CAM instrument, for 5 days from enrollment

Secondary Outcome Measures

Delirium incidence
Proportion of patients in each arm, to developed delirium during daily evaluation
Functional independence
Comparing performance of Activity Daily Living (ADL) at hospital discharge compared to baseline, using FIM (Functional Independence Measure) instrument
Strenght of Grip evaluation
Strength of grip by Jamar Dynamometer, is evaluated to hospitalary discharge
Cognitive State
MMSE (Mini-Mental State Examination), evaluates cognitive state at hospital discharge

Full Information

First Posted
January 10, 2012
Last Updated
May 19, 2014
Sponsor
University of Chile
Collaborators
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile, National Fund for Research and Development in Health, Chile
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1. Study Identification

Unique Protocol Identification Number
NCT01555996
Brief Title
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

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Chile
Collaborators
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile, National Fund for Research and Development in Health, Chile

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Alteration of Cognitive Function, Incompetence, Functional
Keywords
older, delirium, cognitive status, occupational therapy, critically ill patients

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early and intensive OT
Arm Type
Experimental
Arm Title
Standard non-pharmacological prevention
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Early and Intensive Occupational Therapy
Other Intervention Name(s)
Active hospital routine
Intervention Description
Intervention group:Standard non-pharmacological prevention plus early and intensive OT. Begin in the first 24 hours in CCU admission. OT areas:1)Multi-sensory stimulation:Intense external stimulation, increase alertness,2)Positioning: Fixtures like dorxi-flexion splints, devices for preventing edema,etc,3)Cognitive Stimulation: Awareness, orientation, attention, memory, calculation, praxis and language,4)Training Activities of Daily Living (ADL): Keep a daily routine and independence in hygiene, grooming and feeding,5)Upper Limb Motor Stimulation (ULMS): Activate functional movement and strength ,6)Family involvement. General Guidelines for intervention: Visit of an OT twice a day, 40 minutes each time, for 5 days; meeting of family training for promote strategies during the daily visit.
Intervention Type
Behavioral
Intervention Name(s)
Standard non-pharmacological delirium prevention
Other Intervention Name(s)
Recommended non-pharmacological treatment
Intervention Description
Non-pharmacological strategies are the first line of approach in the prevention of delirium. It is recommended to implement some of these strategies, which are: Reorientation protocol, including information 4 times a day about time, date, place and reason for hospitalization; early mobilization by physical therapist 3 times a day, corrected sensory impairment (use such as eyeglasses, hearing aids); environment management, use clock and calendar in the patient´s room, promote supervision of a professional or family to avoid physical restraints; sleep protocol, like lower light, noise and nighttime drug administration and finally, reduction of any anticholinergic drugs and minimize the use of benzodiazepines.
Primary Outcome Measure Information:
Title
To evaluate Delirium duration
Description
Twice a day evaluation for delirium with CAM instrument, for 5 days from enrollment
Time Frame
From second until sixth days hospitalization
Secondary Outcome Measure Information:
Title
Delirium incidence
Description
Proportion of patients in each arm, to developed delirium during daily evaluation
Time Frame
From second until sixth days hospitalization
Title
Functional independence
Description
Comparing performance of Activity Daily Living (ADL) at hospital discharge compared to baseline, using FIM (Functional Independence Measure) instrument
Time Frame
To seventh day of hospitalization and 72 hours before discharge
Title
Strenght of Grip evaluation
Description
Strength of grip by Jamar Dynamometer, is evaluated to hospitalary discharge
Time Frame
To seventh day of hospitalization and 72 hours before discharge
Title
Cognitive State
Description
MMSE (Mini-Mental State Examination), evaluates cognitive state at hospital discharge
Time Frame
To seventh day of hospitalization and 72 hours before discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evelyn Alvarez
Organizational Affiliation
University of Chile
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maricel Garrido
Organizational Affiliation
University of Chile
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Eduardo Tobar
Organizational Affiliation
University of Chile
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rolando Aranda
Organizational Affiliation
University of Chile
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Clinico Universidad de Chile
City
Santiago
State/Province
RM
Country
Chile

12. IPD Sharing Statement

Learn more about this trial

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

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