Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00472

2 Trial Registration Date

2015-08-25

i Registration Status

Prospective

3 Secondary IDs

2015.308

4 Source(s) of Funding

Pending for Health and Medical Research Fund funding approval

5 Primary Sponsor

The Chinese University of Hong Kong

6 Secondary Sponsor

Prince of Wales Hospital

Function

Please specify

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

i Name

Lai Ka Wai, Veronica

ii Address

Office 34, 4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Shatin, NT, Hong Kong SAR, China

iii Phone

23621912

iv Email

veronicalai@link.cuhk.edu.hk

v Affiliation

Prince of Wales Hospital, CUHK

vi Country

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

i Name

Prof Anna Lee

ii Address

Office 21, 4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Shatin, NT, Hong Kong SAR, China

iii Phone

2632 2735

iv Email

annalee@cuhk.edu.hk

v Affiliation

Prince of Wales Hospital, CUHK

vi Country

9 Official Scientific Title of the Study

Patient and family satisfaction levels in the intensive care unit after elective cardiac surgery: a randomized controlled trial of a preoperative patient education intervention

10 Public Title

Patient and family satisfaction levels in the intensive care unit after elective cardiac surgery: a randomized controlled trial of a preoperative patient education intervention

i Public Title in Chinese 研究名稱

病人及家屬對於在擇期心臟手術後入住ICU的滿意度：手術前病人教育的隨機對照試驗

11 Short Title (Optional)

N/A

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?

2015-06-23

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Cardiac surgery

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

1 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.

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 Cantonese. 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

90

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

2015-09-14

21 Target Sample Size

100

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

The primary outcome is satisfaction with ICU care and decision-making process, from the perspective of the patient and patient's family member.

24 Secondary Outcome

The secondary outcomes will be the change in anxiety (and depression) scores using the Chinese-Cantonese version of the Hospital Anxiety and Depression Scale (HADS).

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2020-04-29

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

N/A

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Trial History Detail on 2015-08-25