Ignite Creation Date:
2024-07-17 @ 11:03 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06479031
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-05-07
Brief Title:
Occupational Therapy Intervention on the Prevention of Delirium and Occupational Performance Status in Elderly Patients
Sponsor:
Hospital Sirio-Libanes
Organization:
Hospital Sirio-Libanes
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None