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| Name | Class |
|---|---|
| National University of Singapore | OTHER |
| National Medical Research Council (NMRC), Singapore | OTHER_GOV |
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DREAMS-OT Arm (Intervention Group) | Experimental | Patients will receive an early and intensive occupational therapy protocol starting within the first 15 hours after extubation. |
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| Standard Care Arm (Control Group) | No Intervention | Standard care OT as per current ICU setting |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay | Length of stay in ICU and hospital in days | 3-months post-CABG (+/- 1 month) |
| Duration of Delirium | Duration of delirium in subgroup of participants who develop delirium |
| Measure | Description | Time Frame |
|---|---|---|
| Richmond Agitation Sedation Scale (RASS) | 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. | 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Su Ren Wong | National University Hospital, Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University Hospital | Recruiting | Singapore | 119074 | Singapore |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| 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 | 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 | 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 | 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. | Day 5 of post-CABG (+/- 1 day) |
| Physical Status | Physical status measured using Functional Independence Measure (FIM). The score ranges from 0 - 126, with higher scores indicating better physical status. | Day 5 of post-CABG (+/- 1 day), 3 months post-CABG (+/- 1 month) |
| Cognitive status | Cognitive status measurement using Montreal Cognitive Assessment (MoCA). The score ranges from 0 - 30, with higher scores indicating better cognitive status. | 2 weeks prior to operation (Baseline measurement, +/- 2 weeks), Day 5 of post-CABG (+/- 1 day), 3 months post-CABG (+/- 1 month) |
| Psychological State | Psychological state measured using the Hospital Anxiety and Depression Scale (HADS). The score ranges from 0 - 21, with higher scores indicating worse psychological state. | 2 weeks prior to operation (Baseline measurement, +/- 2 weeks), Day 5 of post-CABG (+/-1 day), 3 months post-CABG (+/- 1 month) |
| Cognitive status | 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. | 3-months post-CABG (+/- 1 month) |
| European System for Cardiac Operative Risk Evaluation (EuroSCORE) 2 | 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. | 2 weeks prior to operation (Baseline measurement, +/- 2 weeks) |
| Charlson Comorbidity Index (CCI) | 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. | 2 weeks prior to operation (Baseline measurement, +/- 2 weeks) |
| Clinical Frailty Index (CFI) | Measure health status of participant before surgery. The score range from 0 - 9, with higher score indicating worse outcome. | 2 weeks prior to operation (Baseline measurement, +/- 2 weeks) |
| ICU Mobility Score | 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. | Day 1, Day 2 and Day 3 of post-CABG (+/- 1 day, or until day of ICU discharge) |
| Pain Score | Measure pain score of participant. The score range from 0 - 10, with higher score indicating worse outcome or greater pain intensity. | 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) |
| Time on Mechanical Ventilation and Ventilator Free Days | Time on Mechanical Ventilation of participant in hours and Ventilator Free Days in days during ICU stay | 3-months post-CABG (+/- 1 month) |
| 30-day readmission and mortality | Incidence of readmission or death within 30 days after CABG | 3-months post-CABG (+/- 1 month) |
| Short Form (36) Health Survey (SF-36) | 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:
| 2 weeks prior to operation (Baseline measurement, +/- 2 weeks), 3-months post-CABG (+/- 1 month) |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |