A randomised controlled trial on smoking cessation and adherence intervention on patients with erectile dysfunction

ISRCTN	ISRCTN13070778
DOI	https://doi.org/10.1186/ISRCTN13070778
Protocol serial number	N/A
Sponsor	The Hong Kong Research Grants Council (China)
Funders	The Hong Kong Research Grants Council (RGC) (China), The Hong Kong Council on Smoking and Health (China)

Submission date: 15/04/2008
Registration date: 13/05/2008
Last edited: 07/09/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Tai-hing Lam
Scientific

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

Phone	+852 2819 9287
Email	hrmrlth@hkucc.hku.hk

Study information

Primary study design	Interventional
Study design	Multicentre randomised single blind placebo controlled study
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	ED Project
Study objectives	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(s)	Ethics Committee, Faculty of Medicine, University of Hong Kong. Date of approval: 19/02/2003 (ref: EC 1966-02)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	1. Quit rate at 6-month follow-up 2. Adherence rate to NRT use at 4 weeks after the first use of NRT
Key secondary outcome measure(s)	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
Completion date	31/10/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Male
Target sample size at registration	1210
Key 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)
Key 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
Date of first enrolment	01/11/2003
Date of final enrolment	31/10/2005

Locations

Countries of recruitment

China

Study participating centre

5/F, William MW Mong Block

Hong Kong
-
China

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2010		Yes	No