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| Name | Class |
|---|---|
| Fondo Nacional de Desarrollo CientĂfico y TecnolĂ³gico, Chile | OTHER_GOV |
| National Fund for Research and Development in Health, Chile | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early and intensive OT | Experimental |
| |
| Standard non-pharmacological prevention | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate Delirium duration | Twice a day evaluation for delirium with CAM instrument, for 5 days from enrollment | From second until sixth days hospitalization |
| Measure | Description | Time Frame |
|---|---|---|
| Delirium incidence | Proportion of patients in each arm, to developed delirium during daily evaluation | From second until sixth days hospitalization |
| Functional independence | Comparing performance of Activity Daily Living (ADL) at hospital discharge compared to baseline, using FIM (Functional Independence Measure) instrument |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evelyn Alvarez | University of Chile | Principal Investigator |
| Maricel Garrido | University of Chile | Study Chair |
| Eduardo Tobar | University of Chile | Study Chair |
| Rolando Aranda | University of Chile | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinico Universidad de Chile | Santiago | RM | Chile |
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| 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. |
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| To seventh day of hospitalization and 72 hours before discharge |
| Strenght of Grip evaluation | Strength of grip by Jamar Dynamometer, is evaluated to hospitalary discharge | To seventh day of hospitalization and 72 hours before discharge |
| Cognitive State | MMSE (Mini-Mental State Examination), evaluates cognitive state at hospital discharge | To seventh day of hospitalization and 72 hours before discharge |
| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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