NCT00563511

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2004

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2007

Completed
Last Updated

June 16, 2011

Status Verified

June 1, 2011

First QC Date

November 21, 2007

Last Update Submit

June 15, 2011

Conditions

Smoking Cessation

Keywords

smoking cessation

Outcome Measures

Primary Outcomes (2)

  • quit rate

    6-month

  • adherence rate

    4-weeks after the first use of NRT

Secondary Outcomes (3)

  • erectile function

    6-month

  • use of NRT

    3-month

  • quit rate

    3-month

Interventions

adherence interventionPROCEDURE
intervention without adherence advicePROCEDURE
controlPROCEDURE

Eligibility Criteria

Age18 Years+
Sexmale
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

HKFPA

Hong Kong, China

Location

Kwong Wah Hospital

Hong Kong, China

Location

The University of Hong Kong

Hong Kong, China

Location

WHO

Hong Kong, China

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Methods

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • TH Lam, Prof

    Department of Community Medicine, The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 21, 2007

First Posted

November 26, 2007

Study Start

January 1, 2004

Study Completion

August 1, 2006

Last Updated

June 16, 2011

Record last verified: 2011-06

Locations

CN(4)