DeliriumNCT06479031
Occupational Therapy Intervention on the Prevention of Delirium and Occupational Performance Status in Elderly Patients
A study testing Occupational Therapy in people with Delirium, run by Hospital Sirio-Libanes.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium
- What is being tested?
- Occupational Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2024to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of an Occupational Therapy Intervention on the Prevention of Delirium and Occupational Performance Status in Elderly Critical Patients: a Randomized Controlled Trial
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.
Read the 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
- Being tested
- Occupational Therapy
- Keywords
- delirium, occupational therapy, confusion, neurocognitive disorders, neurobehavioral manifestations
- Medical subject headings
- Delirium, Confusion, Neurocognitive Disorders, Neurobehavioral Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational TherapyOther
Occupational Therapy intervention, once a day, for 5 days, for 40 minutes each session.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium prevention
With the use of Cognitive Assessment Method - Intensive Care Unit (CAM- ICU).
Measured: 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).
Measured: 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
Characterize care goals related to occupations according to the Canadian Occupational Performance Measure (COPM).
Measured: 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).
Measured: 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.
Measured: Daily for five days, from the initial occupational therapy evaluation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start20 Jul 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Sirio-Libanes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479031
- Sponsor's protocol ID
- AVAP-NG 3405
- Status last verified
- Apr 2024
- First submitted
- 7 May 2024
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40106403
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Occupational Therapy Intervention on the Prevention of Delirium and Occupational Performance Status in Elderly Critical Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06479031
- Acronym / sponsor ID
- AVAP-NG 3405
- Conditions
- Delirium
- Keywords
- delirium, occupational therapy, confusion, neurocognitive disorders, neurobehavioral manifestations
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Hospital Sirio-LibanesUniversity, hospital or other
- Study start
- 20 Jul 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Occupational Therapy1. *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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occupational TherapyOccupational Therapy intervention, once a day, for 5 days, for 40 minutes each session. | Other | Intervention Group - Standard Protocol + Occupational Therapy |
Primary outcome
Delirium prevention
Time frame: 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
With the use of Cognitive Assessment Method - Intensive Care Unit (CAM- ICU).
Improve occupational performance
Time frame: 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.
With the use of Canadian Occupational Performance Measure (COPM).
3 secondary outcomes
Occupations
Time frame: 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
Time frame: 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
Time frame: Daily for five days, from the initial occupational therapy evaluation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Derived from this study: PubMed 40106403de 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Occupational Therapy in people with Delirium, run by Hospital Sirio-Libanes.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christina Brito (5511991065492, christina.brito@hsl.org.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium prevention (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06479031, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.