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Completed

NCT Number: NCT01555996

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

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).

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Key information

Age range

60 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinico Universidad de Chile

Santiago, RM, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Other names: Active hospital routine

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.

Other names: Recommended non-pharmacological treatment

Primary outcomes

  1. To evaluate Delirium duration

    Time frame: From second until sixth days hospitalization

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

Secondary outcomes

  1. Delirium incidence

    Time frame: From second until sixth days hospitalization

    Proportion of patients in each arm, to developed delirium during daily evaluation

  2. Functional independence

    Time frame: 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

  3. Strenght of Grip evaluation

    Time frame: To seventh day of hospitalization and 72 hours before discharge

    Strength of grip by Jamar Dynamometer, is evaluated to hospitalary discharge

  4. Cognitive State

    Time frame: To seventh day of hospitalization and 72 hours before discharge

    MMSE (Mini-Mental State Examination), evaluates cognitive state at hospital discharge

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Collaborators

  • Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
  • National Fund for Research and Development in Health, Chile

Registry information

Official study title

Early Occupational Therapy (OT) for Delirium Prevention in Older Patients Admitted to Critical Care Unit (CCU)

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 16, 2012
Registry last updated
May 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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