Occupational Therapy Intervention on the Prevention of Delirium and Occupational Performance Status in Elderly Patients

NCT06479031 | Not Yet Recruiting

• 1 other identifier: AVAP-NG 3405
• Study Type: interventional
• Target: 114
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Delirium

Keywords

delirium; occupational therapy; confusion; neurocognitive disorders; neurobehavioral manifestations

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Occupations

  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

  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

  Daily for five days, from the initial occupational therapy evaluation.

Study Arms (2)

Control Group - Standard Protocol

NO INTERVENTION

* Early Mobilization Protocol performed by the physiotherapy team twice a day. Institutional protocol for mechanical restraint to prevent physical restriction. * Education for Family Members. * Family member/companion present 24 hours a day with authorized visits at least twice a day. * Minimum as possible sedation.

Intervention Group - Standard Protocol + Occupational Therapy

EXPERIMENTAL

1. \*Occupational Engagement\*: the occupational therapist will encourage the patient's participation in meaningful activities. Adaptations and resources may be utilized to facilitate occupational performance. 2. \*Cognitive Activities\*: Individualized and personalized cognitive activities will be conducted, based on the patient's preferences. 3. \*Environmental Enrichment\*: Installation of a clock and calendar within the patient's visual range on the wall.

Other: Occupational Therapy

Interventions

Occupational Therapy OTHER

Occupational Therapy intervention, once a day, for 5 days, for 40 minutes each session.

Intervention Group - Standard Protocol + Occupational Therapy

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65 years or older.
• Admission to the general ICU.
• Expected stay of more than 48 hours.
• No severe communication disorder.
• No dependence on mechanical ventilation.
• No diagnosis of other neurocognitive disorders.
• Scoring greater than or equal to -2 on the Richmond Agitation-Sedation Scale (RASS).

You may not qualify if:

• Severe visual impairment that impedes the administration of cognitive testing.
• Limited therapeutic efforts and significant comorbidities with a 90-day mortality expectancy (Sequential Organ Failure Assessment (SOFA)/Acute Physiology and Chronic Health Evaluation (APACHE II).

Sponsors & Collaborators

• Hospital Sirio-Libanes: lead

Related Publications (1)

• de Toledo Montesanti L, de Souza Francisco D, Pastore L, Pereira Yamaguti W, Fraga Righetti R, May Moran de Brito C. Person-centered occupational therapy intervention for the prevention of delirium and improvement in occupational performance in elderly patients admitted to an intensive care unit: A randomized controlled single-blinded trial protocol. PLoS One. 2025 Mar 19;20(3):e0319651. doi: 10.1371/journal.pone.0319651. eCollection 2025.

  PMID: 40106403 DERIVED

MeSH Terms

Conditions

Delirium; Confusion; Neurocognitive Disorders; Neurobehavioral Manifestations

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Central Study Contacts

Christina Brito

CONTACT

5511991065492; christina.brito@hsl.org.br

Lorena Montesanti

CONTACT

11971935130; lorena.montesanti@hsl.org.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: June 27, 2024
• Study Start: July 20, 2024
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: June 27, 2024

Record last verified: 2024-04