Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00363

2 Trial Registration Date

2013-03-01

i Registration Status

Prospective

3 Secondary IDs

Nil

4 Source(s) of Funding

Internal funding from The Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong. External funding from the Health and Medical Research Fund has been sought (pending outcome).

5 Primary Sponsor

The Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

6 Secondary Sponsor

Division of Cardiothoracic Surgery, The Chinese University of Hong Kong

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Jinglan Mu

ii Address

Dept.of Anaesthesia & Intensive Care

iii Phone

2632 1912

iv Email

mujinglanbb@gmail.com

v Affiliation

Prince of Wales Hospital, CUHK

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Anna Lee

ii Address

Dept.of Anaesthesia & Intensive Care

iii Phone

2632 2739

iv Email

annalee@cuhk.edu.hk

v Affiliation

Prince of Wales Hospital, CUHK

vi Country

9 Official Scientific Title of the Study

Effect of preoperative patient education on postoperative care in an Intensive care unit for preventing delirium after cardiac surgery: a randomized controlled trial

10 Public Title

Effect of preoperative patient education on postoperative care in an Intensive care unit for preventing delirium after cardiac surgery: a randomized controlled trial

i Public Title in Chinese 研究名稱

隨機對照臨床研究：心臟手術病人術前的教育對預防術后譫妄發生的作用評價

11 Short Title (Optional)

Nil

12 Countries of Recruitment

Hong Kong, China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2013-01-20

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Delirium

15 Intervention

i Types of intervention

Other

Please specify

Patient education

ii Description/ name of Intervention/article

Preoperative patient education using video and ICU tour

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

One hour

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

No formal patient education by ICU staff before surgery, the current standard of care.

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Adult patients undergoing elective coronary artery bypass graft with or without valve replacement surgery, in whom they are all expected to go to ICU for early postoperative care. Patients with at least a daily CAM-ICU assessment will be included in this study.

ii Exclusion Criteria

Patients who have a sustained Richmond Agitation and Sedation Scale (RASS) score of -4 or -5 throughout the ICU admission, have major auditory or visual disorders, have a history of dementia, psychosis or neurological disease that would confound the diagnosis of delirium, are mentally incompetent, or are unable to understand Chinese or English. We will also exclude patients undergoing emergency cardiac surgery, patients who have had a previous cardiac surgery, and those who have received previous care in the ICU.

iii Age Minimum

18

iv Age Maximum

85

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Uncontrolled

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2013-09-01

21 Target Sample Size

182

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

Delirium in the ICU as measured using the Confusion Assessment Method-ICU assessment

by bedside ICU nurses or the use of haloperidol for the treatment of ICU delirium.

24 Secondary Outcome

Anxiety and depression scores using The Chinese-Cantonese version of The Hospital and Anxiety and Depression Scale

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2014-11-06

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-13003081

28 Date of Registration in Primary Registry

2013-03-01

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2013-04-26