Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00617

2 Trial Registration Date

2018-08-01

i Registration Status

Prospective

3 Secondary IDs

2018.205-T

4 Source(s) of Funding

Nil

5 Primary Sponsor

Cheng Nam Sze

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Cheng, Nam Sze

ii Address

Department of Paediartics, Faculty of Medicine, The Chinese University of Hong Kong, 6/F, Prince of Wales Hospital, Shatin, N. T., Hong Kong.

iii Phone

852-90743896

iv Email

nancy_cheng@hotmail.com

v Affiliation

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

vi Country

Hong Kong

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

i Name

Nam Sze Cheng

ii Address

Department of Paediartics, Faculty of Medicine, The Chinese University of Hong Kong, 6/F, Prince of Wales Hospital, Shatin, N. T., 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

The effectiveness of a nurse-led parental eczema education programme for Chinese parents on disease severity, treatment adherence of children with eczema and parental self-efficacy and quality of life of family members: A randomised controlled trial.

10 Public Title

The effectiveness of a nurse-led parental eczema education programme for Chinese parents on disease severity, treatment adherence of children with eczema and parental self-efficacy and quality of life of family members: A randomised controlled trial.

i Public Title in Chinese 研究名稱

驗證「護士主導的家長濕疹教育計劃」對有患有濕疹孩子的中國父母，在減少孩子的濕疹嚴重程度、增加治療依從性、提升父母自我效能感和改善家庭成員生活質量的影響。

11 Short Title (Optional)

Parental eczema education

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?

2018-07-04

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2018.205-T

14 Medical Condition Being Studied

eczema

15 Intervention

i Types of intervention

Other

Please specify

Education on eczema management and sharing

ii Description/ name of Intervention/article

Parent participants in the intervention group will receive a 20-minute one-to-one teaching covering overview of eczema, medical and pharmacological management, practical skills to control eczema (prevention and drug use), habit reversal technique and relaxation exercise, followed by a 10-minute video demonstrating application of emollient, wet wrap and relaxation exercise. Parent participants will also join at least twice weekly an online group sharing of the designated website at home. A phone follow-up will be conducted two days after the commencement of intervention to check the progress of parent participants.

iii Dosage form of the intervention

one-to-one teaching, demonstration video, online group sharing

iv Dosage of the intervention

20-minute one-to-one teaching,10-minute video and online group sharing open for 3 months

v Duration of the intervention

3 months

vi Frequency of the intervention

once one-to-one teaching and video demonstration, not limit access on online sharing within 3 months

16 Comparative Treatments

i Description/ name of comparative treatments

The child participants will receive standard medical treatments as comparative treatments including disease severity assessment by SCORAD, skin hydration and transepidermal water loss measurement, doctor’s consultation and medication prescription.
No extra education provides to parent participants

ii Dosage form of the comparative treatments

once

iii Dosage of the comparative treatments

once

iv Duration of the comparative treatments

once

v Frequency of the comparative treatments

once

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

The inclusion criteria for child participants include age from 3 months to 12 years old and clinical diagnosis of moderate-to-severe eczema.

Parent participants are the parents of children meeting the above criteria who are able to read and understand Chinese.

ii Exclusion Criteria

Children with acute or chronic illnesses requiring systemic treatments will be excluded.

Parents suffering from psychiatric disorders will be excluded.

iii Age Minimum

3 months of child participants and 18 year old of parent participants

iv Age Maximum

12 years old of child participants and no maximum limit to parent participants

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

a randomised controlled trial

ii Nature of control

Dose comparison

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Investigator/research team

iv Group Assignment

Parallel

v Study Phase

1

Please specify

vi Study Objectives (Optional)

The aim of this study is to evaluate the effectiveness of a nurse-led parental eczema education programme for Chinese parents of children with eczema. The outcomes include symptom severity, treatment adherence, parental self-efficacy, and quality of life of parents.

20 Anticipated trial start date

2018-08-20

21 Target Sample Size

136 participants (child-parent dyad).

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Severity of eczema symptoms

ii The metric or method of measurement used

Severity Score of Atopic Dermatitis (SCORAD)

iii The timepoint(s) of primary interest

Baseline and 3 months after the commencement of intervention

24 Secondary Outcome

i The Name of the outcome

Parental self efficacy

ii The metric or method of measurement used

Parental Self-Efficacy with Eczema Care Index

iii The timepoint(s) of primary interest

Baseline and 3 months after the commencement of intervention

Secondary Outcome

i The Name of the outcome

Treatment adherence

ii The metric or method of measurement used

Problematic Experiences of Therapy Scale and report the number of unplanned eczema-related doctor consultations over the past three months.

iii The timepoint(s) of primary interest

Baseline and 3 months after the commencement of intervention

Secondary Outcome

i The Name of the outcome

Quality of life of family members

ii The metric or method of measurement used

Family Dermatology Life Quality Index

iii The timepoint(s) of primary interest

Baseline and 3 months after the commencement of intervention

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2019-12-11

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2018-08-01