Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00583

2 Trial Registration Date

2018-02-12

iRegistration Status

Prospective

3 Secondary IDs

2017.545

4 Source(s) of Funding

Nil

5 Primary Sponsor

Cheng Nam Sze

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Cheng, Nam Sze

ii Address

Flat A, 8/F, University Residence No.17, The Chinese University of Hong Kong

iii Phone

852-90743896

iv Email

nancy_cheng@hotmail.com

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

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

i Name

Nam Sze Cheng

ii Address

Flat A, 8/F, University Residence No.17, The Chinese University of Hong Kong

iii Phone

852-90743896

iv Email

1155062210@link.cuhk.edu.hk

v Affiliation

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

vi Country

Hong Kong

9 Official Scientific Title of the Study

A study to establish the psychometric properties of the Parental Self-Efficacy with Eczema Care Index, Problematic Experiences of Therapy Scale, and Family Dermatology Life Quality Index for children with eczema

10 Public Title

A study to establish the psychometric properties of the Parental Self-Efficacy with Eczema Care Index, Problematic Experiences of Therapy Scale, and Family Dermatology Life Quality Index for children with eczema

i Public Title in Chinese 研究名稱

驗證「父母對孩子濕疹治療的自我效能指數」、「治療時產生問題的經驗感量表」和「皮膚病人家庭成員生活質量調查表」是否適用於患有濕疹的中國兒童及其父母或照顧者

11 Short Title (Optional)

Eczema Measurement Tools

12 Countries of Recruitment

Hong Kong

13Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2018-01-22

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2017.545

14 Medical Condition Being Studied

Eczema

15Intervention

i Types of intervention

Other

Please specify

No intervention, participants just need to complete the questionnaires

ii Description/ name of Intervention/article

This study aims to validate three Chinese version outcome measurement tools for eczema children and their parents, namely the PASECI, PETS and FDLQI on Chinese parents or caregivers of children with eczema in Hong Kong.

iii Dosage form of the intervention

nil

iv Dosage of the intervention

nil

v Duration of the intervention

nil

vi Frequency of the intervention

nil

16Comparative Treatments

i Description/ name of comparative treatments

Nil

ii Dosage form of the comparative treatments

Nil

iii Dosage of the comparative treatments

Nil

iv Duration of the comparative treatments

Nil

v Frequency of the comparative treatments

Nil

17Key Inclusion and Exclusion Criteria

i Inclusion Criteria

The target population of this study is parents or caregivers of children aged from 3 months to 17 years with physician-diagnosed eczema.

ii Exclusion Criteria

Children with acute or chronic illnesses requiring systemic treatment or children and their families with psychiatric disorders will be excluded.

iii Age Minimum

parents or caregivers of children with eczema aged older than 3 months old

iv Age Maximum

parents or caregivers of children with eczema aged younger than 17 years old

v Gender

Both Male and Female

18 Study Type

Observational

19Study 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

1

Please specify

vi Study Objectives (Optional)

This study aims to validate three Chinese version outcome measurement tools for eczema children and their parents, namely the PASECI, PETS and FDLQI on Chinese parents or caregivers of children with eczema in Hong Kong.

20 Anticipated trial start date

2018-02-16

21 Target Sample Size

145

22 Recruitment Status

Complete

23Primary Outcome

iThe Name of the outcome

All items have an acceptable content validity index (CVI)

iiThe metric or method of measurement used

All items in the two tools shall be found to have an acceptable CVI above 0.9 and semantic equivalence above 80% appropriateness.

iiiThe timepoint(s) of primary interest

one month

24Secondary Outcome

iThe Name of the outcome

Reliabilities of the three tools for internal consistency

iiThe metric or method of measurement used

Reliabilities of the three tools will be assessed using Cronbach’s alpha for internal consistency. A reliability coefficient (alpha) of 0.70 or higher is considered acceptable reliability

iiiThe timepoint(s) of primary interest

10 months

Secondary Outcome

iThe Name of the outcome

Test-retest reliability of the three tools

iiThe metric or method of measurement used

Intraclass correlational coefficient for test-retest reliability. ICC that is greater than 0.7 indicated high reliability correlation and ICC of 0.4 to 0.7 is considered acceptable

iiiThe timepoint(s) of primary interest

10 months

Secondary Outcome

iThe Name of the outcome

Known group comparison

iiThe metric or method of measurement used

Known group comparison is assessed by Pearson correlation coefficient for parametric data and Spearman’s rho correlation coefficient

iiiThe timepoint(s) of primary interest

10 months

25Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26Last Update Date

2019-03-28

27 Primary Registry and Trial Identifying Number

ChiCTR1800014892

28 Date of Registration in Primary Registry

2018-02-12

Back History

Trial Detail