Condition category
Mental and Behavioural Disorders
Date applied
31/10/2007
Date assigned
06/11/2007
Last edited
24/05/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sophia Siu-chee Chan

ORCID ID

Contact details

4/F
William MW Mong Block
Li Ka Shing Faculty of Medicine Building
21 Sassoon Road
Pokfulam
-
Hong Kong

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

The nurse delivered stage-matched smoking cessation intervention is to achieve a higher quit rate than the control among Chinese cardiac patients.

Ethics approval

Ethics approval received from the New Territories West Cluster Clinical and Research Ethics Committee on the 14th October 2007 (ref: NTWC/CREC/325/04).

Study design

A multicentre randomised single-blind placebo controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Smoking cessation

Intervention

Intervention: duration is 1 month with an initial face-to-face stage-matched smoking cessation counselling at the outpatient clinic (usually last for 2 - 30 minutes), and 10-minute telephone reminders at 1-week and 1-month, totalling in 40 - 50 minutes. The mean counselling times in the intervention group were 21.07 minutes at baseline, 12.70 minutes at 1-week follow up and 13.31 minutes at 1-month follow up.

Control: receive a healthy diet education manual from our study at the outpatient clinic after randomisation. The mean counselling time in the control group was 17.58 minutes.

Subjects in both groups received standard care after hospitalisation from the individual hospital which may be different from hospital to hospital. All the patients were followed up at 3-month, 6-month, and 12-month after initial contact and self-reported quitters were invited to participate in a urine cotinine test.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Continuous abstinence for one month at the time of 3, 6, and 12 month follow up.

Secondary outcome measures

1. Reduction in the number of cigarette smoked at 3, 6, and 12 months follow up
2. Progression to a higher stage of readiness to quit (5 stages: precontemplation, contemplation, preparation, action, maintenance) at 3, 6, and 12 months follow up

Overall trial start date

06/03/2002

Overall trial end date

31/12/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patient who is admitted to the participating centres and is a current smoker who has smoked daily in the past 7 days prior to hospitalisation
2. Patient speaks and reads Cantonese/Chinese
3. Patient over 18 years, male or female

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1824

Participant exclusion criteria

1. Patient who is clinically too ill and not suitable to complete questionnaire and/or receive intervention
2. Patient who does not speak or read Chinese

Recruitment start date

06/03/2002

Recruitment end date

31/12/2004

Locations

Countries of recruitment

Hong Kong

Trial participating centre

4/F, William MW Mong Block
Pokfulam
-
Hong Kong

Sponsor information

Organisation

The Hong Kong Research Grants Council (RGC) (Hong Kong)

Sponsor details

7/F
Shui On Centre
6 - 8 Harbour Road
Wanchai
Wanchai
-
Hong Kong
+852 (0)2524 3987
ugc@ugc.edu.hk

Sponsor type

Government

Website

http://www.ugc.edu.hk/eng/rgc/index.htm

Funders

Funder type

Government

Funder name

The Hong Kong Research Grants Council (RGC) (Hong Kong) - Earmarked Research Grant 2001-2002 (ref. No: HKU 7224/01M)

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

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22118418

Publication citations

  1. Results

    Chan SS, Leung DY, Wong DC, Lau CP, Wong VT, Lam TH, A randomized controlled trial of stage-matched intervention for smoking cessation in cardiac out-patients., Addiction, 2012, 107, 4, 829-837, doi: 10.1111/j.1360-0443.2011.03733.x.

Additional files

Editorial Notes