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

Completed

• Conditions: Smokers with erectile dysfunction; Mental and Behavioural Disorders; Smoking addiction

• Registration Number: ISRCTN13070778
• Lead Sponsor: The Hong Kong Research Grants Council (China)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-13
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 1210

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)

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Quit rate at 6-month follow-up <br>2. Adherence rate to NRT use at 4 weeks after the first use of NRT

Secondary Outcome Measures

Name	Time	Method
1. Erectile function based on international index of erectile function (IIEF) at 6 months<br>2. Self-reported use of NRT continuously for at least 4 weeks or 8 weeks <br>3. Quit rate at 3 months without validation <br>4. Validated quit rates at 6 months <br>5. Reduction of daily smoking by at least 50% by the subjects at 6 months<br>6. Number of quitting attempts made by the subject at 6 months