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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01555996
Enrollment
126
Registered
2012-03-16
Start date
2011-04-30
Completion date
2012-12-31
Last updated
2014-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alteration of Cognitive Function, Delirium, Incompetence, Functional

Keywords

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

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.

Interventions

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.

BEHAVIORALStandard 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

Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
CollaboratorOTHER_GOV
National Fund for Research and Development in Health, Chile
CollaboratorOTHER
University of Chile
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to 95 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
To evaluate Delirium durationFrom second until sixth days hospitalizationTwice a day evaluation for delirium with CAM instrument, for 5 days from enrollment

Secondary

MeasureTime frameDescription
Delirium incidenceFrom second until sixth days hospitalizationProportion of patients in each arm, to developed delirium during daily evaluation
Functional independenceTo seventh day of hospitalization and 72 hours before dischargeComparing performance of Activity Daily Living (ADL) at hospital discharge compared to baseline, using FIM (Functional Independence Measure) instrument
Strenght of Grip evaluationTo seventh day of hospitalization and 72 hours before dischargeStrength of grip by Jamar Dynamometer, is evaluated to hospitalary discharge
Cognitive StateTo seventh day of hospitalization and 72 hours before dischargeMMSE (Mini-Mental State Examination), evaluates cognitive state at hospital discharge

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026