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| [ Print-friendly version ] |
| A randomised controlled trial on smoking cessation and adherence intervention on patients with erectile dysfunction |
| ISRCTN | ISRCTN13070778 |
| ClinicalTrials.gov identifier | |
| Public title | A randomised controlled trial on smoking cessation and adherence intervention on patients with erectile dysfunction |
| Scientific title | |
| Acronym | ED Project |
| Serial number at source | N/A |
| 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. |
| Countries of recruitment | China |
| Disease/condition/study domain | Smokers with erectile dysfunction |
| Participants - 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) |
| Participants - 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 |
| Anticipated start date | 01/11/2003 |
| Anticipated end date | 31/10/2005 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 1,210 |
| Interventions |
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. |
| 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 |
| 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 |
| Sources of funding |
1. The Hong Kong Research Grants Council (RGC) (China)
2. The Hong Kong Council on Smoking and Health (China) |
| Trial website | |
| Publications | |
| Contact name | Prof Tai-hing Lam |
| Address |
5/F, William MW Mong Block
Li Ka Shing Faculty of Medicine Building 21 Sassoon Road Pokfulam |
| City/town | Hong Kong |
| Zip/Postcode | - |
| Country | China |
| Tel | +852 2819 9287 |
| hrmrlth@hkucc.hku.hk | |
| Sponsor | The Hong Kong Research Grants Council (China) |
| Address |
7/F, Shui On Centre
6-8 Harbour Road Wanchai |
| City/town | Hong Kong |
| Zip/Postcode | - |
| Country | China |
| ugc@ugc.edu.hk | |
| Sponsor website: | http://www.ugc.edu.hk/eng/rgc |
| Date applied | 15/04/2008 |
| Last edited | 13/05/2008 |
| Date ISRCTN assigned | 13/05/2008 |
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