Hospital Clinico Universidad de Chile
Santiago, RM, Chile
NCT Number: NCT01555996
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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Notify Me60 year–95 year
All sexes
Interventional
Not applicable
Santiago, RM, Chile
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: From second until sixth days hospitalization
Twice a day evaluation for delirium with CAM instrument, for 5 days from enrollment
Time frame: From second until sixth days hospitalization
Proportion of patients in each arm, to developed delirium during daily evaluation
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
Time frame: To seventh day of hospitalization and 72 hours before discharge
Strength of grip by Jamar Dynamometer, is evaluated to hospitalary discharge
Time frame: To seventh day of hospitalization and 72 hours before discharge
MMSE (Mini-Mental State Examination), evaluates cognitive state at hospital discharge
University of Chile
Other
Early Occupational Therapy (OT) for Delirium Prevention in Older Patients Admitted to Critical Care Unit (CCU)
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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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