Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00547

2 Trial Registration Date

2017-02-13

iRegistration Status

Prospective

3 Secondary IDs

2016.481

4 Source(s) of Funding

N/A

5 Primary Sponsor

N/A

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Ka Yee Lo

ii Address

C0923, 30 Shepherd Street, Homantin, Kowloon

iii Phone

27686885

iv Email

1002071420@link.cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

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

i Name

Ka Yee Lo

ii Address

C0923, 30 Shepherd Street, Homantin, Kowloon

iii Phone

2768 6885

iv Email

1002071420@link.cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

Evaluation on the effect of a training programme with high-fidelity simulation in enhancing the clinical judgment ability of undergraduate nursing students

10 Public Title

Evaluation on the effect of a training programme with high-fidelity simulation training in enhancing the clinical judgment ability of undergraduate nursing students

i Public Title in Chinese 研究名稱

高擬真情境模擬訓練課程對提升護士學生臨床判斷能力影響的評價

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong

13Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2017-01-14

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2016.481

14 Medical Condition Being Studied

Not applicable

15Intervention

i Types of intervention

Other

Please specify

Educational programme

ii Description/ name of Intervention/article

Hing-fidelity simulation training

iii Dosage form of the intervention

Simulation experience with debriefing

iv Dosage of the intervention

Two sessions

v Duration of the intervention

Half day

vi Frequency of the intervention

N/A

16Comparative Treatments

i Description/ name of comparative treatments

N/A

ii Dosage form of the comparative treatments

N/A

iii Dosage of the comparative treatments

N/A

iv Duration of the comparative treatments

N/A

v Frequency of the comparative treatments

N/A

17Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Senior year undergraduate nursing students who have just completed an Adult and Child Nursing Course in a local university

ii Exclusion Criteria

students retaking the course

Currently receiving similar high-fidelity simulation training

iii Age Minimum

18

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Interventional

19Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Single group

v Study Phase

2

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2017-02-23

21 Target Sample Size

60

22 Recruitment Status

Complete

23Primary Outcome

iThe Name of the outcome

Clinical judgment ability

iiThe metric or method of measurement used

Observation of performance with rubric

iiiThe timepoint(s) of primary interest

Baseline and immediate after intervetnion

24Secondary Outcome

iThe Name of the outcome

Knowledge

iiThe metric or method of measurement used

Written test

iiiThe timepoint(s) of primary interest

Baseline and immediate after intervention

25Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26Last Update Date

2018-05-10

27 Primary Registry and Trial Identifying Number

ChiCTR-OPC-17010626

28 Date of Registration in Primary Registry

2017-02-13

Back History

Trial Detail