Smoking CessationNCT01935505
Study on the Model of Smoking Cessation Intervention and Service Ability Improvement
An observational study of Smoking Cessation, run by Chinese PLA General Hospital.
Trial summary
This is a observation non-randomized control trial, and a follow-up study on the smoking cessation. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Consulting, Nicotine patch and Telephone intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Dec 2018
- Phase
- Observational
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: hospital-based population
Who may be able to join
- current smoker aged 18 years or above, Chinese,
- agreed to participate in the follow-up and signed an informed consent form.
Who cannot join
- cognitively impaired and with severe diseases,
- occasional or daily smoker,
- Disagree and non-signed an informed consent form.
About this study
Official title: Study on the Model of Smoking Cessation Intervention and Service Ability Improvement in General Hospital
This is a observation non-randomized control trial, and a follow-up study on the smoking cessation.
Read the detailed description
This is a observation non-randomized control trial, and a follow-up study on the smoking cessation.
To study the intervention methods of smoking cessation in a general hospital and to evaluate their effects. Four methods of specialist intervention of smoking cessation clinic, short-time intervention in out patients, free medical intervention and group intervention were adopted for different smokers, with health counseling, psychological intervention and drug treatment. The intervention effect was evaluated by standard methods.
The whole project will last for 10 years in total, from Oct.2008 to Dec.2018. During the running, each quitter received follow-up at 1 week, 1, 3, 6 months and 1, 2 years using a detailed questionnaire by telephone interview, an expected average of 2 years.
- Conditions
- Smoking Cessation
- Being tested
- Consulting, Nicotine patch, Telephone intervention, Consulting+Telephone+Drug intervention
- Keywords
- smoking cessation, intervention model, Chinese, quitting rate
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConsultingBehavioural
The physicians adopted a non-directive approach, included the five 'A' (ask, advice, assess, assist and arrange), assessing the stage of readiness in quitting smoking, strengthening clients' motivation to quit smoking using the five 'R' (relevance, risks, rewards, roadblocks and repetition) approach, and providing advice to overcome psychological craving, psychological dependence and social-cultural factors associated with tobacco dependency. Each smoker takes more than 30 min to complete the intervention.
Nicotine patchDrug
Also called Nicotine Replacement Therapy: Nicotine patch, bupropion, varenicline
According to the smokers' level of nicotine dependency, disease history, cigarette consumption, prescription of drugs were provided, Nicotine Replacement Therapy, bupropion and varenicline.
Telephone interventionBehavioural
Smokers received follow-up by a counselor at 1 week, 1, 3, 6 months and 1, 2 years using a detailed questionnaire by telephone interview. At each follow-up, we collected data, asked whether the smokers have any problem with drug use or other problems, provided problem-oriented suggestions or advice as appropriate, encouraged them to insist.
Consulting+Telephone+Drug interventionBehavioural
Include all the above interventions
| Study group | Role | What they receive |
|---|---|---|
| Consulting group | The physicians adopted a non-directive approach, included the five 'A' (ask, advice, assess, assist and arrange), assessing the stage of readiness in quitting smoking, strengthening clients' motivation to quit smoking using the five 'R' (relevance, risks, rewards, roadblocks and repetition) approach, and providing advice to overcome psychological craving, psychological dependence and social-cultural factors associated with tobacco dependency. Each smoker takes more than 30 min to complete the intervention. Receives: Behavioral: Consulting | |
| Drug intervention group | According to the smokers' level of nicotine dependency, disease history, cigarette consumption, prescription of drugs were provided, Nicotine Replacement Therapy, bupropion and varenicline. Receives: Behavioral: Consulting; Drug: Nicotine patch; Behavioral: Telephone intervention | |
| Telephone intervention group | Smokers received follow-up by a counselor at 1 week, 1, 3, 6 months and 1, 2 years using a detailed questionnaire by telephone interview. At each follow-up, we collected data, asked whether the smokers have any problem with drug use or other problems, provided problem-oriented suggestions or advice as appropriate, encouraged them to insist. Receives: Behavioral: Consulting; Behavioral: Telephone intervention | |
| Consulting+Telephone+Drug intervention | All the interventions above are include in this group Receives: Behavioral: Consulting+Telephone+Drug intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
quitting rate
The whole project will last for 10 years in total, from Oct.2008 to Dec.2018. During the running, each participant will be followed by telephone tracking, an expected average of 2 years.
Measured: up to 10 years
Secondary outcomes (1)
decrease of tobacco consumption
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startOct 2008
- Primary completionSep 2013 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yao He, Chinese PLA General Hospital
- Investigators
- Yao He, MD, PhD, Principal investigator, Institute of Geriatrics, Chinese PLA General Hospital, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935505
- Sponsor's protocol ID
- IGPLAGH301YaoHe
- Status last verified
- Sep 2013
- First submitted
- 25 Aug 2013
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jiang B, He Y, Zuo F, Wu L, Liu QH, Zhang L, Zhou CX, Cheng KK, Chan SS, Lam TH. Effectiveness of varenicline and counselling for smoking cessation in an observational cohort study in China. BMJ Open. 2016 Jan 6;6(1):e009381. doi: 10.1136/bmjopen-2015-009381.
PubMed 26739730
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Model of Smoking Cessation Intervention and Service Ability Improvement in General Hospital
- ClinicalTrials.gov ID
- NCT01935505
- Acronym / sponsor ID
- IGPLAGH301YaoHe
- Conditions
- Smoking Cessation
- Keywords
- smoking cessation, intervention model, Chinese, quitting rate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 5 Sep 2013 (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.
This is a observation non-randomized control trial, and a follow-up study on the smoking cessation.
Detailed description
This is a observation non-randomized control trial, and a follow-up study on the smoking cessation.
To study the intervention methods of smoking cessation in a general hospital and to evaluate their effects. Four methods of specialist intervention of smoking cessation clinic, short-time intervention in out patients, free medical intervention and group intervention were adopted for different smokers, with health counseling, psychological intervention and drug treatment. The intervention effect was evaluated by standard methods.
The whole project will last for 10 years in total, from Oct.2008 to Dec.2018. During the running, each quitter received follow-up at 1 week, 1, 3, 6 months and 1, 2 years using a detailed questionnaire by telephone interview, an expected average of 2 years.
Study design
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Consulting group | – | Behavioral: ConsultingThe physicians adopted a non-directive approach, included the five 'A' (ask, advice, assess, assist and arrange), assessing the stage of readiness in quitting smoking, strengthening clients' motivation to quit smoking using the five 'R' (relevance, risks, rewards, roadblocks and repetition) approach, and providing advice to overcome psychological craving, psychological dependence and social-cultural factors associated with tobacco dependency. Each smoker takes more than 30 min to complete the intervention. |
| Drug intervention group | – | Behavioral: Consulting, Drug: Nicotine patch, Behavioral: Telephone interventionAccording to the smokers' level of nicotine dependency, disease history, cigarette consumption, prescription of drugs were provided, Nicotine Replacement Therapy, bupropion and varenicline. |
| Telephone intervention group | – | Behavioral: Consulting, Behavioral: Telephone interventionSmokers received follow-up by a counselor at 1 week, 1, 3, 6 months and 1, 2 years using a detailed questionnaire by telephone interview. At each follow-up, we collected data, asked whether the smokers have any problem with drug use or other problems, provided problem-oriented suggestions or advice as appropriate, encouraged them to insist. |
| Consulting+Telephone+Drug intervention | – | Behavioral: Consulting+Telephone+Drug interventionAll the interventions above are include in this group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- hospital-based population
Key inclusion criteria (2 listed)
- current smoker aged 18 years or above, Chinese,
- agreed to participate in the follow-up and signed an informed consent form.
Key exclusion criteria (3 listed)
- cognitively impaired and with severe diseases,
- occasional or daily smoker,
- Disagree and non-signed an informed consent form.
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 |
|---|---|---|
| ConsultingThe physicians adopted a non-directive approach, included the five 'A' (ask, advice, assess, assist and arrange), assessing the stage of readiness in quitting smoking, strengthening clients' motivation to quit smoking using the five 'R' (relevance, risks, rewards, roadblocks and repetition) approach, and providing advice to overcome psychological craving, psychological dependence and social-cultural factors associated with tobacco dependency. Each smoker takes more than 30 min to complete the intervention. | Behavioural | Consulting group, Drug intervention group, Telephone intervention group |
| Nicotine patchAlso: Nicotine Replacement Therapy: Nicotine patch, bupropion, vareniclineAccording to the smokers' level of nicotine dependency, disease history, cigarette consumption, prescription of drugs were provided, Nicotine Replacement Therapy, bupropion and varenicline. | Drug | Drug intervention group |
| Telephone interventionSmokers received follow-up by a counselor at 1 week, 1, 3, 6 months and 1, 2 years using a detailed questionnaire by telephone interview. At each follow-up, we collected data, asked whether the smokers have any problem with drug use or other problems, provided problem-oriented suggestions or advice as appropriate, encouraged them to insist. | Behavioural | Drug intervention group, Telephone intervention group |
| Consulting+Telephone+Drug interventionInclude all the above interventions | Behavioural | Consulting+Telephone+Drug intervention |
Primary outcome
quitting rate
Time frame: up to 10 years
The whole project will last for 10 years in total, from Oct.2008 to Dec.2018. During the running, each participant will be followed by telephone tracking, an expected average of 2 years.
1 secondary outcome
decrease of tobacco consumption
Time frame: up to 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2013.
- Derived from this study: PubMed 26739730Jiang B, He Y, Zuo F, Wu L, Liu QH, Zhang L, Zhou CX, Cheng KK, Chan SS, Lam TH. Effectiveness of varenicline and counselling for smoking cessation in an observational cohort study in China. BMJ Open. 2016 Jan 6;6(1):e009381. doi: 10.1136/bmjopen-2015-009381.
Related trials for Smoking Cessation
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Active, not recruitingPhase 4
Implementing Tobacco Treatment in Low Dose CT Lung Cancer Screening Sites
Smoking Cessation
Recruiting
Personalized Tobacco Treatment in Primary Care (MOTIVATE)
Physician's Role, Smoking Cessation
Active, not recruitingEarly Phase 1
Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung Cancer
Smoking Cessation
Not yet recruiting
Comparing the Efficacy of a Conversational Agent (QuitBot) Versus Standard Health Education on Smoking Cessation Among Medical Students in Cairo University
Conversational Agent, 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.
Yao He, MD, PhD principal investigator
Institute of Geriatrics, Chinese PLA General Hospital, Beijing, China
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking Cessation, run by Chinese PLA 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 2 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: status not confirmed, as of the sponsor's last update on 5 Sep 2013. 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?
Results are not available in the source record.
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?
quitting rate (time frame: up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01935505, which also lists 1 linked publication.
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 5 Sep 2013; AzTrials last refreshed its copy on 6 Nov 2026.