Early Occupational Therapy for Delirium Prevention in Older Patients Admitted to Critical Care Unit
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|ClinicalTrials.gov Identifier: NCT01555996|
Recruitment Status : Completed
First Posted : March 16, 2012
Last Update Posted : May 21, 2014
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).
|Condition or disease||Intervention/treatment||Phase|
|Delirium Alteration of Cognitive Function Incompetence, Functional||Behavioral: Early and Intensive Occupational Therapy Behavioral: Standard non-pharmacological delirium prevention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Early Occupational Therapy (OT) for Delirium Prevention in Older Patients Admitted to Critical Care Unit (CCU)|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||December 2012|
|Experimental: Early and intensive OT||
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.
Other Name: Active hospital routine
|Active Comparator: Standard non-pharmacological prevention||
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.
Other Name: Recommended non-pharmacological treatment
- 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
- Delirium incidence [ Time Frame: From second until sixth days hospitalization ]Proportion of patients in each arm, to developed delirium during daily evaluation
- 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
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01555996
|Hospital Clinico Universidad de Chile|
|Santiago, RM, Chile|
|Principal Investigator:||Evelyn Alvarez||University of Chile|
|Study Chair:||Maricel Garrido||University of Chile|
|Study Chair:||Eduardo Tobar||University of Chile|
|Study Chair:||Rolando Aranda||University of Chile|