A Randomized Controlled Trial on Smoking Cessation and Adherence Intervention on Patients With Erectile Dysfunction

June 15, 2011 updated by: Hospital Authority, Hong Kong
The purpose of this proposed RCT is to test (a) the effectiveness of smoking cessation intervention (counseling and NRT) among patients with ED; and (b) the effectiveness of adherence intervention (ADIN) to increase adherence to NRT use in order to increase quit rate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • The University of Hong Kong
      • Hong Kong, China
        • Kwong Wah Hospital
      • Hong Kong, China
        • HKFPA
      • Hong Kong, China
        • WHO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male ethnic Chinese aged 18 or above
  • Smokes at least 1 cigarette per day
  • Is not following other forms of smoking cessation interventions
  • Intends to quit smoking within the next 7 days of the first contact and would use NRT
  • Free from illness that contraindicate to the use of NRT
  • Has signed an informed consent form, or has given verbal consent (for those contacted by telephone)

Exclusion Criteria:

  • Patients who are psychologically or physically unable to communicate
  • Children and teenagers (aged below 18)
  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
quit rate
Time Frame: 6-month
6-month
adherence rate
Time Frame: 4-weeks after the first use of NRT
4-weeks after the first use of NRT

Secondary Outcome Measures

Outcome Measure
Time Frame
erectile function
Time Frame: 6-month
6-month
use of NRT
Time Frame: 3-month
3-month
quit rate
Time Frame: 3-month
3-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Authority, Hong Kong

Collaborators

The University of Hong Kong

Investigators

  • Principal Investigator: TH Lam, Prof, Department of Community Medicine, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

November 21, 2007

First Submitted That Met QC Criteria

November 23, 2007

First Posted (Estimate)

November 26, 2007

Study Record Updates

Last Update Posted (Estimate)

June 16, 2011

Last Update Submitted That Met QC Criteria

June 15, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC1966-02
  • HARECCTR0500052
  • HKU7428/03M

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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