Early Occupational Therapy for Delirium Prevention in Older Patients Admitted to Critical Care Unit
This study has been completed.
Sponsor:
University of Chile
Collaborators:
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
Fondo Nacional de Investigacion en Salud (FONIS)
Escuela de Terapia Ocupacional, Facultad de Medicina
Information provided by (Responsible Party):
Evelyn Alvarez Espinoza, OT, Principal Investigator, University of Chile
ClinicalTrials.gov Identifier:
NCT01555996
First received: January 10, 2012
Last updated: January 11, 2013
Last verified: January 2013
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Purpose
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 | Intervention |
|---|---|
|
Delirium Alteration of Cognitive Function Incompetence, Functional |
Behavioral: Early and Intensive Occupational Therapy Behavioral: Standard non-pharmacological delirium prevention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Early Occupational Therapy (OT) for Delirium Prevention in Older Patients Admitted to Critical Care Unit (CCU) |
Resource links provided by NLM:
Further study details as provided by University of Chile:
Primary Outcome Measures:
- To evaluate Delirium duration [ Time Frame: From second until sixth days hospitalization ] [ Designated as safety issue: No ]Twice a day evaluation for delirium with CAM instrument, for 5 days from enrollment
Secondary Outcome Measures:
- Delirium incidence [ Time Frame: From second until sixth days hospitalization ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]MMSE (Mini-Mental State Examination), evaluates cognitive state at hospital discharge
| Estimated Enrollment: | 126 |
| Study Start Date: | April 2011 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
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.
Eligibility| Ages Eligible for Study: | 60 Years to 95 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01555996
Locations
| Chile | |
| Hospital Clinico Universidad de Chile | |
| Santiago, RM, Chile | |
Sponsors and Collaborators
University of Chile
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
Fondo Nacional de Investigacion en Salud (FONIS)
Escuela de Terapia Ocupacional, Facultad de Medicina
Investigators
| 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 |
More Information
No publications provided
| Responsible Party: | Evelyn Alvarez Espinoza, OT, Principal Investigator, E Alvarez, University of Chile |
| ClinicalTrials.gov Identifier: | NCT01555996 History of Changes |
| Other Study ID Numbers: | SA10I20015 |
| Study First Received: | January 10, 2012 |
| Last Updated: | January 11, 2013 |
| Health Authority: | Chile: Comisión Nacional de Investigación Científica y Tecnológica |
Keywords provided by University of Chile:
|
older delirium cognitive status occupational therapy critically ill patients |
Additional relevant MeSH terms:
|
Delirium Confusion Neurobehavioral Manifestations Neurologic Manifestations |
Nervous System Diseases Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013