Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00645

2 Trial Registration Date

2018-12-12

i Registration Status

Prospective

3 Secondary IDs

CREC 2018.430

4 Source(s) of Funding

N/A

5 Primary Sponsor

The Nethersole School of Nursing, CUHK

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Prof. Li Wai Chi, Polly

ii Address

Room 828, Esther Lee Building, The Chinese University of Hong Kong
Shatin, N.T., Hong Kong

iii Phone

39439905

iv Email

liwaichi@cuhk.edu.hk

v Affiliation

The Nethersole School of Nursing , The Chinese University of Hong Kong

vi Country

Hong Kong

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

i Name

Prof. Li Wai Chi, Polly

ii Address

Room 828, Esther Lee Building, The Chinese University of Hong Kong
Shatin, N.T., Hong Kong

iii Phone

39439905

iv Email

liwaichi@cuhk.edu.hk

v Affiliation

The Nethersole School of Nursing , The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

Psychometric evaluation of the Chinese version of the Atrial Fibrillation Effect on QualiTy-of-Life questionnaire and the Atrial Fibrillation Knowledge Scale

10 Public Title

Psychometric evaluation of the Chinese version of the Atrial Fibrillation Effect on QualiTy-of-Life questionnaire and the Atrial Fibrillation Knowledge Scale

i Public Title in Chinese 研究名稱

中文版「心房顫動對生活質素的影響量表」及「心房顫動知識量表」用於心房顫動患者的驗證研究

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2018-10-08

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2018.430

14 Medical Condition Being Studied

Atrial Fibrillation

15 Intervention

i Types of intervention

Other

Please specify

Measurement tools validation study, not an interventional study

ii Description/ name of Intervention/article

N/A

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

N/A

16 Comparative 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

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Community-dwelling Chinese patients aged 18 or above, with a confirmed diagnosis of AF, able to communicate in Cantonese and willing to give consent

ii Exclusion Criteria

Patients who are cognitively impaired, unable to communicate and those with active psychiatric illnesses

iii Age Minimum

18

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Observational

19 Study Design

i Randomization

Not Applicable

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

0

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2018-12-24

21 Target Sample Size

200

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

1. Atrial Fibrillation Effect on Quality-of-life; 2. Atrial Fibrillation Knowledge, 3. Quality of Life

ii The metric or method of measurement used

1. Atrial Fibrillation Effect on Quality-of-life (Chinese version, AFEQT-C); 2. Atrial Fibrillation Knowledge Scale (AF knowledge scale; Chinese version); 3. EuroQoL 5-Dimentional Questionnaire (EQ-5D)

iii The timepoint(s) of primary interest

24 Secondary Outcome

i The Name of the outcome

N/A

ii The metric or method of measurement used

N/A

iii The timepoint(s) of primary interest

N/A

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2019-09-06

27 Primary Registry and Trial Identifying Number

ChiCTR1900021041

28 Date of Registration in Primary Registry

2018-12-12

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Trial History Detail on 2019-01-29