Smoking CessationNCT03474783
To Explore the Factors Affecting the Effectiveness of Smoking Cessation
A study testing Health education in people with Smoking Cessation, run by Cathay General Hospital.
Trial summary
Objectives: Promoting quitting smoking and training smoking cessation educators in hospital, school, community, and workplace was being vigorously pushed by Health Promotion Administration. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- No sites listed yet
- Study dates
- 22 Sep 2015to 2 Feb 2017
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- being a current smoker (who had smoked more than 100 cigarettes in their lifetime),
- aged > 20 years,
- with clear consciousness,
- being able to communicate using Mandarin or Taiwanese
Who cannot join
- with acute psychiatric disorders,
- inability to complete the questionnaire
About this study
Objectives:
Promoting quitting smoking and training smoking cessation educators in hospital, school, community, and workplace was being vigorously pushed by Health Promotion Administration. Since the implementation of the second-generation smoking cessation program by Health Promotion Administration, both the general public and medical institutions have worked with greater vitality to practice and promote quitting smoking. However, studies on smoking cessation in the inpatient remain inadequate. Increasing cessation motivation for inpatient smokers and evaluating their nicotine dependence are essential. In this study, we aimed to explore the factors that might influence the smoking cessation in the inpatients.
Read more
Method: A cross-sectional questionnaire survey was conducted on inpatients participants at the smoking cessation.
Questionnaire comprising（1）Demographic characteristics: age, sex, marital status, education, （2）physiological factors（concentration of carbon monoxide, nicotine dependence, disease severity）,（3）psychological factors（psychological dependence on smoking , smoking cessation stages of behavior change, smoking cessation self-efficacy）, （4）Social Factor: social support,（5）smoking Behavior indicators: smoked, daily cigarette consumption, smoking experience. After giving health education cessation of treatment one month, three months and six months, interviewed by telephone quitting behavior index contains daily cigarette consumption, quit rates point.
- Conditions
- Smoking Cessation
- Being tested
- Health education
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health educationBehavioural
Stages of change of intentions to cease smoking of participants at the baseline were determined, and a personal-tailored health education was accordingly delivered.
| Study group | Role | What they receive |
|---|---|---|
| multidisciplinary intervention | Experimental | Not described Receives: Behavioral: Health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
point prevalence abstinence
whether quitting smoking
Measured: 1 month after intervention
Secondary outcomes (2)
point prevalence abstinence
whether quitting smoking
Measured: 3 months after intervention
point prevalence abstinence
whether quitting smoking
Measured: 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start22 Sep 2015
- Primary completion30 Jun 2016
- Study completion2 Feb 2017
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
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cathay General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cathay General Hosp. IRB, Cathay General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474783
- Sponsor's protocol ID
- CGH-P 104061
- Status last verified
- Mar 2018
- First submitted
- 15 Mar 2018
- Last updated
- 23 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Explore the Factors Affecting the Effectiveness of Smoking Cessation
- ClinicalTrials.gov ID
- NCT03474783
- Acronym / sponsor ID
- CGH-P 104061
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Cathay General HospitalUniversity, hospital or other
- Study start
- 22 Sep 2015 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 2 Feb 2017 (actual)
- First posted
- 23 Mar 2018 (actual)
- 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.
Objectives:
Promoting quitting smoking and training smoking cessation educators in hospital, school, community, and workplace was being vigorously pushed by Health Promotion Administration. Since the implementation of the second-generation smoking cessation program by Health Promotion Administration, both the general public and medical institutions have worked with greater vitality to practice and promote quitting smoking. However, studies on smoking cessation in the inpatient remain inadequate. Increasing cessation motivation for inpatient smokers and evaluating their nicotine dependence are essential. In this study, we aimed to explore the factors that might influence the smoking cessation in the inpatients.
Method: A cross-sectional questionnaire survey was conducted on inpatients participants at the smoking cessation.
Questionnaire comprising（1）Demographic characteristics: age, sex, marital status, education, （2）physiological factors（concentration of carbon monoxide, nicotine dependence, disease severity）,（3）psychological factors（psychological dependence on smoking , smoking cessation stages of behavior change, smoking cessation self-efficacy）, （4）Social Factor: social support,（5）smoking Behavior indicators: smoked, daily cigarette consumption, smoking experience. After giving health education cessation of treatment one month, three months and six months, interviewed by telephone quitting behavior index contains daily cigarette consumption, quit rates point.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| multidisciplinary intervention | Experimental | Behavioral: Health education |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- being a current smoker (who had smoked more than 100 cigarettes in their lifetime),
- aged > 20 years,
- with clear consciousness,
- being able to communicate using Mandarin or Taiwanese
Key exclusion criteria (2 listed)
- with acute psychiatric disorders,
- inability to complete the questionnaire
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 |
|---|---|---|
| Health educationStages of change of intentions to cease smoking of participants at the baseline were determined, and a personal-tailored health education was accordingly delivered. | Behavioural | multidisciplinary intervention |
Primary outcome
point prevalence abstinence
Time frame: 1 month after intervention
whether quitting smoking
2 secondary outcomes
point prevalence abstinence
Time frame: 3 months after intervention
point prevalence abstinence
Time frame: 6 months after intervention
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 23 Mar 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Health education in people with Smoking Cessation, run by Cathay General Hospital.
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 4 inclusion and 2 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 23 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
point prevalence abstinence (time frame: 1 month after intervention). 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 23 Mar 2018.