Smoking CessationNCT00563511
A Randomized Controlled Trial on Smoking Cessation and Adherence Intervention on Patients With Erectile Dysfunction
A study testing adherence intervention and intervention without adherence advice in people with Smoking Cessation, run by Hospital Authority, Hong Kong at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- adherence intervention and intervention without adherence advice
- Type of treatment
- Surgery or procedure
- How many people
- 1,210 participants
- Where
- 4 sitesChina
- Study dates
- Jan 2004to Aug 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
China4 sites
HKFPA
Hong Kong
Kwong Wah Hospital
Hong Kong
The University of Hong Kong
Hong Kong
WHO
Hong Kong
About this study
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.
- Conditions
- Smoking Cessation
- Being tested
- adherence intervention, intervention without adherence advice, control
- Keywords
- smoking cessation
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adherence interventionProcedure or surgery
intervention without adherence adviceProcedure or surgery
controlProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
quit rate
Measured: 6-month
adherence rate
Measured: 4-weeks after the first use of NRT
Secondary outcomes (3)
erectile function
Measured: 6-month
use of NRT
Measured: 3-month
quit rate
Measured: 3-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2007 (estimated)
- Study startJan 2004
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 1,210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Collaborators
- The University of Hong Kong
- Investigators
- TH Lam, Prof, Principal investigator, Department of Community Medicine, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00563511
- Sponsor's protocol ID
- EC1966-02
- Other IDs
- HARECCTR0500052, HKU7428/03M
- Status last verified
- Jun 2011
- First submitted
- 21 Nov 2007
- Last updated
- 16 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on Smoking Cessation and Adherence Intervention on Patients With Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT00563511
- Acronym / sponsor ID
- EC1966-02
- Conditions
- Smoking Cessation
- Keywords
- smoking cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,210 participants (estimated)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Collaborators
- The University of Hong Kong
- Study start
- Jan 2004
- Study completion
- Aug 2006 (actual)
- First posted
- 26 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adherence intervention | Procedure or surgery | – |
| intervention without adherence advice | Procedure or surgery | – |
| control | Procedure or surgery | – |
Primary outcome
quit rate
Time frame: 6-month
adherence rate
Time frame: 4-weeks after the first use of NRT
3 secondary outcomes
erectile function
Time frame: 6-month
use of NRT
Time frame: 3-month
quit rate
Time frame: 3-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2011.
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Using Smartwatches to Monitor Smoking in Real-life Situations
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Smoking Cessation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TH Lam, Prof principal investigator
Department of Community Medicine, The University of Hong Kong
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adherence intervention and intervention without adherence advice in people with Smoking Cessation, run by Hospital Authority, Hong Kong at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quit rate (time frame: 6-month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2011.