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Recruiting NCT06107517

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

No phase Interventional Delirium, Postoperative

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DREAMS-OT.
Who it may be relevant to
Registry conditions: Delirium, Postoperative. Basic parameters: 21 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Singapore
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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.

Interventions

  • Other 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.

Primary outcome measures

  • 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)]
  • 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)]
Secondary outcome measures (8)
  • Length of Stay [Time frame: 3-months post-CABG (+/- 1 month)]
  • 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)]
  • 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)]
  • Functional Status [Time frame: Day 5 of post-CABG (+/- 1 day)]
  • Physical Status [Time frame: Day 5 of post-CABG (+/- 1 day), 3 months post-CABG (+/- 1 month)]
  • 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)]
  • 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)]
  • Cognitive status [Time frame: 3-months post-CABG (+/- 1 month)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Singapore · 1 center
  • National University Hospital — Singapore

Identifiers

NCT: NCT06107517 · 2022/00936

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗