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

This study has been completed.
Sponsor:
Collaborator:
Dept of Community Medicine, HKU
Information provided by:
Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
NCT00563511
First received: November 21, 2007
Last updated: June 15, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention
Smoking Cessation
 Procedure: adherence intervention
Procedure: intervention without adherence advice
Procedure: control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Official Title: A Randomized Controlled Trial on Smoking Cessation and Adherence Intervention on Patients With Erectile Dysfunction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital Authority, Hong Kong:

Primary Outcome Measures:
  • quit rate [ Time Frame: 6-month ]
  • adherence rate [ Time Frame: 4-weeks after the first use of NRT ]

Secondary Outcome Measures:
  • erectile function [ Time Frame: 6-month ]
  • use of NRT [ Time Frame: 3-month ]
  • quit rate [ Time Frame: 3-month ]

Estimated Enrollment: 1210
Study Start Date: January 2004
Study Completion Date: August 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00563511

Locations
China
Kwong Wah Hospital
Hong Kong, China
HKFPA
Hong Kong, China
The University of Hong Kong
Hong Kong, China
WHO
Hong Kong, China
Sponsors and Collaborators
Hospital Authority, Hong Kong
Dept of Community Medicine, HKU
Investigators
Principal Investigator: TH Lam, Prof Department of Community Medicine, The University of Hong Kong
  More Information

Additional Information:
Hong Kong: Ethics Committee  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00563511     History of Changes
Other Study ID Numbers: EC1966-02, HARECCTR0500052, HKU7428/03M
Study First Received: November 21, 2007
Last Updated: June 15, 2011
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Hospital Authority, Hong Kong:
smoking cessation

Additional relevant MeSH terms:
Smoking
Erectile Dysfunction
Habits
Sexual Dysfunction, Physiological
 Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013