Condition category
Mental and Behavioural Disorders
Date applied
15/04/2008
Date assigned
13/05/2008
Last edited
07/09/2011
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

Prof Tai-hing Lam

ORCID ID

Contact details

5/F
William MW Mong Block
Li Ka Shing Faculty of Medicine Building
21 Sassoon Road
Pokfulam
Hong Kong
-
China
+852 2819 9287
hrmrlth@hkucc.hku.hk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

ED Project

Study hypothesis

1. The quit rate is higher in the intervention group than in the control group
2. In the intervention group, a) the adherence rate to nicotine replacement therapy (NRT) and b) the quit rate are greater in those who have received additional adherence intervention than those who have not

Ethics approval

Ethics Committee, Faculty of Medicine, University of Hong Kong. Date of approval: 19/02/2003 (ref: EC 1966-02)

Study design

Multicentre randomised single blind placebo controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Smokers with erectile dysfunction

Intervention

Intervention group 1: Face-to-face stage-matched smoking cessation counselling delivered by trained counsellors at initial contact, 1 week and 1 month with nicotine replacement therapy adherence intervention.

Intervention group 2: Face-to-face stage-matched smoking cessation counselling delivered by trained counsellors at initial contact, 1 week and 1 month without nicotine replacement therapy adherence intervention.

Control: A placebo healthy diet education material and usual care provided by the hospital.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Quit rate at 6-month follow-up
2. Adherence rate to NRT use at 4 weeks after the first use of NRT

Secondary outcome measures

1. Erectile function based on international index of erectile function (IIEF) at 6 months
2. Self-reported use of NRT continuously for at least 4 weeks or 8 weeks
3. Quit rate at 3 months without validation
4. Validated quit rates at 6 months
5. Reduction of daily smoking by at least 50% by the subjects at 6 months
6. Number of quitting attempts made by the subject at 6 months

Overall trial start date

01/11/2003

Overall trial end date

31/10/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Ethnicity: Chinese
2. Age 18 or above, male
3. Those with erectile dysfunction
4. Smokes at least 1 cigarette per day
5. Intends to quit smoking within the next 7 days of the first contact and would use NRT
6. Has no contradictions to NRT
7. Is not following other forms of smoking cessation interventions
8. Has signed an informed consent form, or have given verbal consent (for those contacted by telephone)

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

1,210

Participant exclusion criteria

1. Patients who are psychologically or physically unable to communicate
2. Children and teenagers (age below 18)
3. Those on regular psychotropic medications and in the presence of any serious health problems that may make them unsuitable for using NRT, such as recent stroke, palpitation, or other life threatening conditions

Recruitment start date

01/11/2003

Recruitment end date

31/10/2005

Locations

Countries of recruitment

China

Trial participating centre

5/F, William MW Mong Block
Hong Kong
-
China

Sponsor information

Organisation

The Hong Kong Research Grants Council (China)

Sponsor details

7/F
Shui On Centre
6-8 Harbour Road
Wanchai
Hong Kong
-
China
ugc@ugc.edu.hk

Sponsor type

University/education

Website

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

Funders

Funder type

University/education

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Hong Kong Council on Smoking and Health (China)

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

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20709257

Publication citations

  1. Results

    Chan SS, Leung DY, Abdullah AS, Lo SS, Yip AW, Kok WM, Ho SY, Lam TH, Smoking-cessation and adherence intervention among Chinese patients with erectile dysfunction., Am J Prev Med, 2010, 39, 3, 251-258, doi: 10.1016/j.amepre.2010.05.006.

Additional files

Editorial Notes