A randomised controlled trial on smoking cessation and adherence intervention on patients with erectile dysfunction
ISRCTN | ISRCTN13070778 |
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DOI | https://doi.org/10.1186/ISRCTN13070778 |
Secondary identifying numbers | N/A |
- 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
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 |
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hrmrlth@hkucc.hku.hk |
Study information
Study design | Multicentre randomised single blind placebo controlled study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
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 | 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 study start date | 01/11/2003 |
Completion date | 31/10/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Male |
Target number of participants | 1,210 |
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
-
China
Sponsor information
The Hong Kong Research Grants Council (China)
University/education
University/education
7/F, Shui On Centre
6-8 Harbour Road
Wanchai
Hong Kong
-
China
ugc@ugc.edu.hk | |
Website | http://www.ugc.edu.hk/eng/rgc |
https://ror.org/00djwmt25 |
Funders
Funder type
University/education
The Hong Kong Research Grants Council (RGC) (China)
No information available
The Hong Kong Council on Smoking and Health (China)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/09/2010 | Yes | No |