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

ISRCTN ISRCTN13070778
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

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

Study designMulticentre randomised single blind placebo controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymED Project
Study objectives1. 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) studiedSmokers with erectile dysfunction
InterventionIntervention 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 typeOther
Primary outcome measure1. Quit rate at 6-month follow-up
2. Adherence rate to NRT use at 4 weeks after the first use of NRT
Secondary outcome measures1. 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 date01/11/2003
Completion date31/10/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexMale
Target number of participants1,210
Key inclusion criteria1. 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 criteria1. 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 enrolment01/11/2003
Date of final enrolment31/10/2005

Locations

Countries of recruitment

  • China

Study participating centre

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

Sponsor information

The Hong Kong Research Grants Council (China)
University/education

7/F, Shui On Centre
6-8 Harbour Road
Wanchai
Hong Kong
-
China

Email ugc@ugc.edu.hk
Website http://www.ugc.edu.hk/eng/rgc
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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