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NCT Number: NCT06107517

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

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

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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Key information

Conditions

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

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National University Hospital

Singapore, 119074

Location status: Recruiting

Location contact

Bee Choo Tai

SUB_INVESTIGATOR

Geetha Kayambu

SUB_INVESTIGATOR

Graeme MacLaren

SUB_INVESTIGATOR

Guohao Chang

SUB_INVESTIGATOR

Hui Min Chua

SUB_INVESTIGATOR

Hui Minn Chan

SUB_INVESTIGATOR

Kit Cheng Ting

SUB_INVESTIGATOR

Lian Kah Ti

SUB_INVESTIGATOR

Megan HL Tan

CONTACT

[email protected]

Najjar Raymond

SUB_INVESTIGATOR

Ong Li Xin

SUB_INVESTIGATOR

Rachel Lee

SUB_INVESTIGATOR

Ramanathan Kollengode Ramaswamy

SUB_INVESTIGATOR

Su Ren Wong

CONTACT

[email protected]

+65-90279451

Su Ren Wong

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Delirium

    Time frame: 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)

    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.

  2. Delirium

    Time frame: 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)

    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).

Secondary outcomes

  1. Length of Stay

    Time frame: 3-months post-CABG (+/- 1 month)

    Length of stay in ICU and hospital in days

  2. Duration of Delirium

    Time frame: 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)

    Duration of delirium in subgroup of participants who develop delirium

  3. Sleep Quality

    Time frame: 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)

    Sleep quality (Duration of Total Sleep, Light Sleep, Deep Sleep and Rapid Eye Movement (REM) Sleep in hours) as measured with Oura Ring, a wearable sleep tracking device

  4. Functional Status

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

    Functional status measured using Acute Care Index of Function (ACIF). The score ranges from 0 - 176 (or 206 for wheelchair-bound participants), with higher scores indicating better functional performance.

  5. Physical Status

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

    Physical status measured using Functional Independence Measure (FIM). The score ranges from 0 - 126, with higher scores indicating better physical status.

  6. Cognitive status

    Time frame: 2 weeks prior to operation (Baseline measurement, +/- 2 weeks), Day 5 of post-CABG (+/- 1 day), 3 months post-CABG (+/- 1 month)

    Cognitive status measurement using Montreal Cognitive Assessment (MoCA). The score ranges from 0 - 30, with higher scores indicating better cognitive status.

  7. Psychological State

    Time frame: 2 weeks prior to operation (Baseline measurement, +/- 2 weeks), Day 5 of post-CABG (+/-1 day), 3 months post-CABG (+/- 1 month)

    Psychological state measured using the Hospital Anxiety and Depression Scale (HADS). The score ranges from 0 - 21, with higher scores indicating worse psychological state.

  8. Cognitive status

    Time frame: 3-months post-CABG (+/- 1 month)

    Cognitive status measured using the Weekly Calendar Planning Activity (WCPA) is assessed using an efficiency score derived from accuracy and time to completion. Higher scores indicate better performance. The score is a continuous variable without a fixed range.

Other outcomes

  1. Richmond Agitation Sedation Scale (RASS)

    Time frame: 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)

    RASS which will be used for CAM-ICU assessment (primary outcome measure). The scores range from -5 to +4, with higher score indicating greater agitation and lower scores indicating deeper sedation.

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

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

    EuroSCORE 2 is used to assess the risk of heart surgery of participants before their CABG surgery. The score ranges from 0% - 100%, with higher percentage indicating worse outcome or greater predicted mortality risk.

  3. Charlson Comorbidity Index (CCI)

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

    Predicts mortality for participant before CABG surgery. The score ranges from 0 - 37, with higher score indicating worse outcome or greater comorbidity burden and mortality risk.

  4. Clinical Frailty Index (CFI)

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

    Measure health status of participant before surgery. The score range from 0 - 9, with higher score indicating worse outcome.

  5. ICU Mobility Score

    Time frame: Day 1, Day 2 and Day 3 of post-CABG (+/- 1 day, or until day of ICU discharge)

    Assesses the highest level of mobility achieved in the ICU. The score range from 0 - 10, with higher score indicating better ouctome or greater mobility.

  6. Pain Score

    Time frame: Day 1 of post-CABG, Day 2 of post-CABG, Day 3 of post-CABG, Day 4 of post-CABG, Day 5 of post-CABG (+/- 1 day, or until day of ICU discharge)

    Measure pain score of participant. The score range from 0 - 10, with higher score indicating worse outcome or greater pain intensity.

  7. Time on Mechanical Ventilation and Ventilator Free Days

    Time frame: 3-months post-CABG (+/- 1 month)

    Time on Mechanical Ventilation of participant in hours and Ventilator Free Days in days during ICU stay

  8. 30-day readmission and mortality

    Time frame: 3-months post-CABG (+/- 1 month)

    Incidence of readmission or death within 30 days after CABG

  9. Short Form (36) Health Survey (SF-36)

    Time frame: 2 weeks prior to operation (Baseline measurement, +/- 2 weeks), 3-months post-CABG (+/- 1 month)

    A survey that determines quality of life. The summary of the health components Physical Health Component (PCS) and Mental Health Component (MCS) are derived from eight subscales PF, RP, BP, GH, VT, SF, RE, MH), where the minimum score represents the worst health and the maximum score represents the best health. The minimum and maximum score of the subscales are as follow:

    • PF (minimum 19.3, maximum 57.5),
    • RP (minimum 21.2, maximum 57.2),
    • BP (minimum 21.7, maximum 62.0),
    • GH (minimum 19.0, maximum 66.5),
    • VT (minimum 22.9, maximum 70.4),
    • SF (minimum 17.2, maximum 57.3),
    • RE (minimum 14.4, maximum 56.2),
    • MH (minimum 11.6, maximum 63.9).

Study contacts

Contact information is provided by the study sponsor or research team.

Megan HL Tan

CONTACT

[email protected]

+65-96280613

Michell KS Low

CONTACT

[email protected]

+65 83164092

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Collaborators

  • National Medical Research Council (NMRC), Singapore
  • National University of Singapore

Registry information

Official study title

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

Acronym: DREAMS-OT

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 30, 2023
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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