Occupational Therapy Intervention on the Prevention of Delirium and Occupational Performance Status in Elderly Patients
NCT Number: NCT06479031
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Delirium
Interventions: OTHER: Occupational Therapy
Sponsor: Hospital Sirio-Libanes
Sex: ALL
Age: OLDER_ADULT
Enrollment: 114
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-07-20
Completion Date: 2026-01-01

Summary:
Delirium is an acute, fluctuating, transient, and usually reversible disorder of cognition and level of consciousness, with a high incidence in critical care units, especially in the elderly. Its occurrence leads to unfavorable outcomes such as increased length of stay, morbidity, functional and cognitive decline, increased mortality, and healthcare costs, in addition to being emotionally challenging for family members and caregivers. Although there are instruments and interventions for screening, prevention, and management, it remains underdiagnosed and undertreated. Among non-pharmacological interventions, the role of Occupational Therapy (OT) has been highlighted in the literature for promising results, such as reducing delirium incidence and duration, as well as improving functional outcomes at hospital discharge. OT protocols described in the literature vary in their frequency and intensity of care, as well as in the composition of their interventions. This research aims to test the hypothesis that a protocol composed of interventions based on meaningful occupations and personalized cognitive stimulation with patient-interest themes may reduce delirium incidence and improve occupational performance in elderly patients admitted to critical care units, compared to the standard protocol.

Primary Outcome Measures: Delirium prevention, With the use of Cognitive Assessment Method - Intensive Care Unit (CAM- ICU)., Daily for 5 days, from the initial evaluation. The diagnosis involves four criteria. If the patient scores on criteria 1, 2, and 3 (acute onset or fluctuating course; inattention; altered level of consciousness) or if they score a value ≥2 on criterion 4|Improve occupational performance, With the use of Canadian Occupational Performance Measure (COPM)., At baseline and after of the 5 days. This tool evaluates three domains (importance, occupational performance, and satisfaction) ranging from 1 to 10 points, with higher scores reflecting better outcomes.
Secondary Outcome Measures: Occupations, Characterize care goals related to occupations according to the Canadian Occupational Performance Measure (COPM)., At baseline and after of the 5 days. This tool evaluates three domains (importance, occupational performance, and satisfaction) ranging from 1 to 10 points, with higher scores reflecting better outcomes.|Cognitive Status, With the use of the Montreal Cognitive Assessment (MoCA test)., At baseline and after of the 5 days. The MoCA Test has scores ranging from 0 to 30 points, with higher scores representing better cognitive performance. Scores above 26 are considered normal.|Adverse effects, Descriptive and quantitative analysis of occurences., Daily for five days, from the initial occupational therapy evaluation.