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

NCT ID: NCT06479031

Last Updated: 2024-06-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-20
• Study Completion Date: 2026-01-01

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.

Detailed Description

Engagement in meaningful occupations promotes health in various contexts and needs to be further investigated regarding its applicability in delirium prevention, associated with cognitive stimulation. Most protocols propose OT sessions twice daily, posing a challenge to their applicability in clinical practice. Therefore, there is also a need to study an intervention with lower frequency and greater feasibility.

In this way, the research will have as its primary objective to Evaluate the effect of a new OT protocol on delirium prevention and occupational performance in elderly patients admitted to critical care units, while the secondary objectives will be:

• Characterize care goals related to occupations according to their respective areas (self-care, productivity, or leisure), patient-defined satisfaction, and importance.
• Assess the impact of OT intervention on cognitive status.
• Identify possible adverse events related to OT intervention. The sample will consist of elderly patients, aged 65 years or older, admitted to the general ICU, and who are not intubated. The sample will be randomized, with patients in the control group receiving standard intervention, while those in the experimental group will receive standard intervention plus daily Occupational Therapy.

Conditions

Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control Group - Standard Protocol

• 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention Group - Standard Protocol + Occupational Therapy

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.

Group Type: EXPERIMENTAL

Occupational Therapy

Intervention Type: OTHER

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

Interventions

Occupational Therapy

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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).

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Sirio-Libanes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Christina Brito

Role: CONTACT

christina.brito@hsl.org.br

5511991065492

Lorena Montesanti

Role: CONTACT

lorena.montesanti@hsl.org.br

11971935130

References

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.

Reference Type: DERIVED

PMID: 40106403 (View on PubMed)

Other Identifiers

AVAP-NG 3405

Identifier Type: -

Identifier Source: org_study_id