Condition category
Mental and Behavioural Disorders
Date applied
22/07/2012
Date assigned
30/07/2012
Last edited
01/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Passive smoking represents a serious health hazard and is a substantial threat to child health increasing risk of acute respiratory illness in children. Nurses are in a vital position to conduct health education to improve children’s health, which is a legitimate activity in a pediatric ward. This study assesses the effectiveness of nurses providing health education intervention to mothers of sick children aiming to prevent the children from exposure to secondhand smoke (SHS) and to help the fathers quit.

Who can participate?
The subjects are non-smoking mothers of sick children who admitted to the paediatric ward and with a smoking husband living in the same household. Sick children who were admitted to the hospital with other relatives (other than the mother) or maids were excluded from the study.

What does the study involve?
The non-smoking mothers are randomly assigned into two groups. One group (intervention group) the nurses provide mothers with a 3-mins standardized health advice on the health hazard of SHS exposure, one purpose-designed booklet to suggest mothers take actions to prevent SHS exposure of their sick children and other suggestions for them to encourage and assist their husbands stop smoking and a self-help smoking cessation booklet for mothers to bring back to their husband; and a telephone reminder to the mothers one week later.
Another group (control group) only receives normal care provided by nurses, and there is no specific advice on secondhand smoke exposure during normal care. Both groups are contacted by nurse counselors at 3-, 6-, and 12-month by telephone for follow-up interviews.

What are the possible benefits and risks of participating?
There is no risk for mothers to participate the study. We will not provide incentives to participants, but we hope the mothers in the intervention group can have immediate direct benefit by reducing their children from SHS exposure and helping their husband stop smoking.

Where is the study run from?
This study is conducted by School of Nursing, The University of Hong Kong. Participants are recruited in the pediatric wards and outpatient departments of four major acute hospitals under the Hong Kong Hospital Authority: Queen Mary Hospital, Pamela Youde Nethersole Eastern Hospital, Kwong Wah Hospital and Yan Chai Hospital.
.
When is study starting and how long is it expected to run for?
The recruitment of participant was started in November 1997 and completed in September 1998. The 12-month telephone interview ended in September 1999.

Who is funding the study?
Research Fund Secretariat, Food and Health Bureau, Hong Kong

Who is the main contact?
Professor Sophia Chan
nssophia@hku.hk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Sophia Chan

ORCID ID

Contact details

4/F William MW Mong Block
School of Nursing
University of Hong Kong
21 Sassoon Road
Pokfulam
-
852
Hong Kong

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

611004

Study information

Scientific title

A randomised control trial (RCT) of a nurse-led brief advice to mothers of sick children in preventing household secondhand smoke exposure and encouraging fathers to quit smoking in Hong Kong

Acronym

HSRC

Study hypothesis

Brief advice provided by nurses to mothers of sick children could be effective in improving household secondhand smoke exposure (SHS) and indirectly encouraging fathers to quit smoking.

Ethics approval

Ethics Committee of the Faculty of Medicine, University of Hong Kong, September 1997, ref: EC-150

Study design

Prospective multi-centred single-blinded two-armed randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Sick children in the paediatric wards / outpatient departments, with non-smoking mothers and smoking fathers

Intervention

The intervention group received a health education intervention provided by nurses, which included:
1. Giving standardised health advice
2. Two purpose-designed health education booklets (SHS booklet for the mother and Quit Smoking booklet for the father
3. A purpose-designed sticker
4. A telephone reminder one week later

No intervention was given to the control group except the normal care provided by nurses. No advice on SHS was given during normal care.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The 7-day point-prevalence quit rate of the child' s father proxy reported by spouse at 12-month follow-up

Secondary outcome measures

1. The 7-day point-prevalence quit rate of the child' s father at 3- and 6-month follow-up proxy reported by spouse
2. The mother's behavior in protecting the child from exposure to SHS, such as moving the child away from the smoking fathers and /or other smokers
3. Change in the smoking habits of the child's father such as reduction in smoking (in general, at home, and near the child)

Overall trial start date

01/11/1997

Overall trial end date

30/09/1999

Reason abandoned

Eligibility

Participant inclusion criteria

1. Non-smoking mothers who bring their sick child to the hospital
2. The child's father is a current smoker
3. Mother, father and child are living together in the same household
4. The mother speaks and reads Cantonese Chinese

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

1840

Participant exclusion criteria

Sick children who were admitted to the hospital with other relatives (other than the mother) or with maids

Recruitment start date

01/11/1997

Recruitment end date

30/09/1999

Locations

Countries of recruitment

Hong Kong

Trial participating centre

4/F William MW Mong Block
-
852
Hong Kong

Sponsor information

Organisation

Food and Health Bureau (Hong Kong)

Sponsor details

Research Fund Secretariat
Research Office
18/F
Murray Building
Garden Road
-
852
Hong Kong

Sponsor type

Government

Website

http://www.fhb.gov.hk/grants/english/welcome/welcome.html

Funders

Funder type

Government

Funder name

Health Services Research Fund, Hong Kong SAR Government (Hong Kong) ref: HSRC 611004

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2003 results in http://www.ncbi.nlm.nih.gov/pubmed/14702863
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16671973
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18785372
2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23565835

Publication citations

  1. Results

    Chan S, Lam TH, Preventing exposure to second-hand smoke., Semin Oncol Nurs, 2003, 19, 4, 284-290.

  2. Results

    Chan S, Lam TH, Protecting sick children from exposure to passive smoking through mothers' actions: a randomized controlled trial of a nursing intervention., J Adv Nurs, 2006, 54, 4, 440-449, doi: 10.1111/j.1365-2648.2006.03842.x.

  3. Results

    Chan SS, Leung GM, Wong DC, Lam TH, Helping Chinese fathers quit smoking through educating their nonsmoking spouses: a randomized controlled trial., Am J Health Promot, 23, 1, 31-34, doi: 10.4278/ajhp.07043040.

  4. Results

    Chan SS, Wong DC, Lam TH, Will mothers of sick children help their husbands to stop smoking after receiving a brief intervention from nurses? Secondary analysis of a randomised controlled trial., BMC Pediatr, 2013, 13, 50, doi: 10.1186/1471-2431-13-50.

Additional files

Editorial Notes