Reducing Delirium After CABG Surgery With Early Activation and Sleep-Promoting Routines

NCT06107517 | Recruiting DMC

• 1 other identifier: 2022/00936
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized-controlled trial (RCT) is to compare the effectiveness of the DREAMS-OT intervention with standard care in reducing post-Coronary Artery Bypass Graft (CABG) surgery delirium in patients undergoing CABG surgery. The aims of the study are:

1. 1.To determine if early and intensive OT will lower the incidence of post-op delirium in CABG patients compared to standard are.
2. 2.To determine the cost effectiveness of the DREAMS-OT intervention.

Conditions

Delirium, Postoperative

Keywords

Delirium; Coronary Artery Bypass Grafting; Occupational Therapy; Intensive Care Units; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• Delirium

  Incidence of delirium from Day 1 to Day 5 post-CABG are measured using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) assessment tool.

  Day 1 of post-CABG (AM and PM), Day 2 of post-CABG (AM and PM), Day 3 of post-CABG (AM and PM), Day 4 of post-CABG (AM and PM), Day 5 of post-CABG (AM and PM); (+/- 1 day for last measurement)

• Delirium

  Incidence of delirium from Day 1 to Day 5 post-CABG are measured using the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM).

  Day 1 of post-CABG (AM and PM), Day 2 of post-CABG (AM and PM), Day 3 of post-CABG (AM and PM), Day 4 of post-CABG (AM and PM), Day 5 of post-CABG (AM and PM); (+/- 1 day for last measurement)

Secondary Outcomes (8)

• Length of Stay

  3-months post-CABG (+/- 1 month)

• Duration of Delirium

  Day 1 of post-CABG (AM and PM), Day 2 of post-CABG (AM and PM), Day 3 of post-CABG (AM and PM), Day 4 of post-CABG (AM and PM), Day 5 of post-CABG (AM and PM)

• Sleep Quality

  2 weeks prior to operation (Baseline measurement, +/- 2 weeks), Day 1 of post-CABG, Day 2 of post-CABG (+/- 1 day), 3 months post-CABG for 3 consecutive days (+/- 1 month)

• Functional Status

  Day 5 of post-CABG (+/- 1 day)

• Physical Status

  Day 5 of post-CABG (+/- 1 day), 3 months post-CABG (+/- 1 month)

Other Outcomes (9)

• Richmond Agitation Sedation Scale (RASS)

  Day 1 of post-CABG (AM and PM), Day 2 of post-CABG (AM and PM), Day 3 of post-CABG (AM and PM), Day 4 of post-CABG (AM and PM), Day 5 of post-CABG (AM and PM)

• European System for Cardiac Operative Risk Evaluation (EuroSCORE) 2

  2 weeks prior to operation (Baseline measurement, +/- 2 weeks)

• Charlson Comorbidity Index (CCI)

  2 weeks prior to operation (Baseline measurement, +/- 2 weeks)

Study Arms (2)

DREAMS-OT Arm (Intervention Group)

EXPERIMENTAL

Patients will receive an early and intensive occupational therapy protocol starting within the first 15 hours after extubation.

Other: DREAMS-OT

Standard Care Arm (Control Group)

NO INTERVENTION

Standard care OT as per current ICU setting

Interventions

DREAMS-OT OTHER

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.

DREAMS-OT Arm (Intervention Group)

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients deemed medically suitable for elective CABG surgery
• Patients aged 21 years and above
• Patients who are English or Mandarin speaking.
• Patients who are able to provide consent

You may not qualify if:

• Patients who speak other languages are excluded due to the language requirements of certain outcome measures.
• 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.

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• National University of Singapore: collaborator
• National Medical Research Council (NMRC), Singapore: collaborator

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

RECRUITING

MeSH Terms

Conditions

Emergence Delirium; Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Su Ren Wong

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan HL Tan

CONTACT

+65-96280613; megan_huei_lin_tan@nuhs.edu.sg

Michell KS Low

CONTACT

+65 83164092; michell_kai_sian_low@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 30, 2023
• Study Start: January 8, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)