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

NCT01555996 | Completed

• 1 other identifier: SA10I20015
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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).

Conditions

Delirium; Alteration of Cognitive Function; Incompetence, Functional

Keywords

older; delirium; cognitive status; occupational therapy; critically ill patients

Outcome Measures

Primary Outcomes (1)

• To evaluate Delirium duration

  Twice a day evaluation for delirium with CAM instrument, for 5 days from enrollment

  From second until sixth days hospitalization

Secondary Outcomes (4)

• Delirium incidence

  From second until sixth days hospitalization

• Functional independence

  To seventh day of hospitalization and 72 hours before discharge

• Strenght of Grip evaluation

  To seventh day of hospitalization and 72 hours before discharge

• Cognitive State

  To seventh day of hospitalization and 72 hours before discharge

Study Arms (2)

Early and intensive OT

EXPERIMENTAL

Behavioral: Early and Intensive Occupational Therapy

Standard non-pharmacological prevention

ACTIVE COMPARATOR

Behavioral: Standard non-pharmacological delirium prevention

Interventions

Early and Intensive Occupational Therapy BEHAVIORAL

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.

Also known as: Active hospital routine

Early and intensive OT

Standard non-pharmacological delirium prevention BEHAVIORAL

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.

Also known as: Recommended non-pharmacological treatment

Standard non-pharmacological prevention

Eligibility Criteria

• Age: 60 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Chile: lead
• Fondo Nacional de Desarrollo Científico y Tecnológico, Chile: collaborator
• National Fund for Research and Development in Health, Chile: collaborator

Study Sites (1)

Hospital Clinico Universidad de Chile

Santiago, RM, Chile

Location

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

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

Study Officials

• Evelyn Alvarez

  University of Chile

  PRINCIPAL INVESTIGATOR

• Maricel Garrido

  University of Chile

  STUDY CHAIR

• Eduardo Tobar

  University of Chile

  STUDY CHAIR

• Rolando Aranda

  University of Chile

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: E Alvarez

Study Record Dates

• First Submitted: January 10, 2012
• First Posted: March 16, 2012
• Study Start: April 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 21, 2014

Record last verified: 2014-05

Locations

CL (1)