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
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
-
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.