Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00648

2 Trial Registration Date

2018-12-18

i Registration Status

Prospective

3 Secondary IDs

1.2

4 Source(s) of Funding

The PI

5 Primary Sponsor

The PI

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Mr LAI KA WING

ii Address

Accident and Emergency Medicine Academic Unit,
Main Clinical Block and Trauma Centre,
Prince of Wales Hospital, Shatin,

iii Phone

46421749

iv Email

1155105190@link.cuhk.edu.hk

v Affiliation

Mr

vi Country

CHINA

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

i Name

Mr LAI KA WING

ii Address

Accident and Emergency Medicine Academic Unit,
Main Clinical Block and Trauma Centre,
Prince of Wales Hospital, Shatin,

iii Phone

46421749

iv Email

1155105190@link.cuhk.edu.hk

v Affiliation

Accident and Emergency Medicine Academic Unit , CUHK

vi Country

CHINA

9 Official Scientific Title of the Study

Why AED Consulation Instead of Other Primary Halthcare Settings? A Study on “Relationship between Utilization of Accident & Emergency Department and Other Primary Healthcare Settings”

10 Public Title

Why AED Consulation Instead of Other Primary Halthcare Settings? A Study on “Relationship between Utilization of Accident & Emergency Department and Other Primary Healthcare Settings”

i Public Title in Chinese 研究名稱

關於「急症室及其他基層醫療服務機構使用關係」的研究

11 Short Title (Optional)

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?

2018-11-22

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2018.460

14 Medical Condition Being Studied

N/A

15 Intervention

i Types of intervention

Other

Please specify

Leaflet

ii Description/ name of Intervention/article

A PHC leaflet

iii Dosage form of the intervention

N/A

iv Dosage of the intervention

N/A

v Duration of the intervention

N/A

vi Frequency of the intervention

one-off

16 Comparative Treatments

i Description/ name of comparative treatments

Other leaflet

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

one-off

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

All PWH AED patients who aged ≥18 years old

ii Exclusion Criteria

All medically unstable patients , ambulance-transferred patients, unable to understand Chinese/ English, or unable to make an informed consent

iii Age Minimum

18

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Use digital generator

ii Nature of control

Placebo

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Trial subjects

iv Group Assignment

Parallel

v Study Phase

Other

Please specify

Not drug test

vi Study Objectives (Optional)

20 Anticipated trial start date

2018-12-24

21 Target Sample Size

380

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

AED attendance

ii The metric or method of measurement used

Direct counting

iii The timepoint(s) of primary interest

3-month

24 Secondary Outcome

i The Name of the outcome

Frailty

ii The metric or method of measurement used

Fraility index

iii The timepoint(s) of primary interest

Secondary Outcome

i The Name of the outcome

Comorbidity

ii The metric or method of measurement used

Charlson’s Comorbidity Score

iii The timepoint(s) of primary interest

Secondary Outcome

i The Name of the outcome

Self-care Ability

ii The metric or method of measurement used

Barthel Index

iii The timepoint(s) of primary interest

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2019-03-25

27 Primary Registry and Trial Identifying Number

ChiCTR1900021045

28 Date of Registration in Primary Registry

2018-12-18

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Trial History Detail on 2019-03-25