DREAMS-OT Trial: Delirium Reduction Through Early Activation in Motivating and Sleep Promoting Routines: A Randomized Controlled Trial of Occupational Therapy for ICU Patients After Coronary Artery Bypass Graft (CABG) Surgery
NCT ID: NCT06107517
Last Updated: 2023-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2023-10-31
2025-08-31
Brief Summary
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The aims of the study are:
* Conduct a prospective randomized controlled trial comparing the effectiveness of the DREAMS-OT intervention with standard care in reducing post-CABG delirium in Cardiothoracic Intensive Care Unit (CTICU)
* To conduct a nested cost-effectiveness study
The study team will compare intervention group and standard care group (control group) to see if there is a reduction in the incidence of delirium in patients 5 days post-CABG.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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DREAMS-OT Arm (Intervention Group)
Patients will receive an early and intensive occupational therapy protocol starting within the first 15 hours after extubation.
DREAMS-OT
Patients will receive the DREAMS-OT protocol 3 times per day, 20 minutes per therapy session.
Intervention frequency will be confirmed with a feasibility trial. If not feasible to maintain 3 times per day, the intervention will still be maintained at the same intensity of 1 hour per day, with a graded approach.
Standard Care Arm (Control Group)
Standard care OT as per current ICU setting
No interventions assigned to this group
Interventions
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DREAMS-OT
Patients will receive the DREAMS-OT protocol 3 times per day, 20 minutes per therapy session.
Intervention frequency will be confirmed with a feasibility trial. If not feasible to maintain 3 times per day, the intervention will still be maintained at the same intensity of 1 hour per day, with a graded approach.
Eligibility Criteria
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Inclusion Criteria
* Patients aged 21 years and above
* Patients who are English or Mandarin speaking.
* Patients who are able to provide consent
Exclusion Criteria
* Patients with premorbid severe hearing impairment, severe cognitive impairment, progressive neurological disorders and psychological disorders will be excluded.
* Patients with surgical complications resulting in profuse bleeding from any invasive sites, septic shock unresponsive to maximal treatment, and those who are moribund or have an expected mortality within 48 hours will be excluded.
* Pregnant women will also be excluded from the study as well.
* Patients who develop delirium before initiation of the treatment are also excluded from the study.
21 Years
99 Years
ALL
No
Sponsors
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National University of Singapore
OTHER
National Medical Research Council (NMRC), Singapore
OTHER_GOV
National University Hospital, Singapore
OTHER
Responsible Party
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Principal Investigators
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Su Ren Wong
Role: PRINCIPAL_INVESTIGATOR
National University Hospital, Singapore
Central Contacts
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Other Identifiers
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2022/00936
Identifier Type: -
Identifier Source: org_study_id
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