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

NCT01555996 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2014-05-21

No results posted yet for this study

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

Interventions

BEHAVIORAL

Early and Intensive Occupational Therapy

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.

BEHAVIORAL

Standard non-pharmacological delirium prevention

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.

Sponsors & Collaborators

  • Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

    collaborator OTHER_GOV
  • National Fund for Research and Development in Health, Chile

    collaborator OTHER
  • University of Chile

    lead OTHER

Principal Investigators

  • Evelyn Alvarez · University of Chile

  • Maricel Garrido · University of Chile

  • Eduardo Tobar · University of Chile

  • Rolando Aranda · University of Chile

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2012-07-31
Completion
2012-12-31

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01555996 on ClinicalTrials.gov