NCT01935505

Brief Summary

This is a observation non-randomized control trial, and a follow-up study on the smoking cessation.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2008

Longer than P75 for all trials

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2013

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2013

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

September 5, 2013

Status Verified

September 1, 2013

Enrollment Period

4.9 years

First QC Date

August 25, 2013

Last Update Submit

September 4, 2013

Conditions

Keywords

smoking cessationintervention modelChinesequitting rate

Outcome Measures

Primary Outcomes (1)

  • 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.

    up to 10 years

Secondary Outcomes (1)

  • decrease of tobacco consumption

    up to 10 years

Other Outcomes (1)

  • changes of Knowledge Attitude and Practice

    up to 10 years

Study Arms (4)

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.

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.

Behavioral: ConsultingDrug: Nicotine patchBehavioral: 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.

Behavioral: ConsultingBehavioral: Telephone intervention

Consulting+Telephone+Drug intervention

All the interventions above are include in this group

Behavioral: Consulting+Telephone+Drug intervention

Interventions

ConsultingBEHAVIORAL

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.

Consulting groupDrug intervention groupTelephone 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.

Also known as: Nicotine Replacement Therapy: Nicotine patch, bupropion, varenicline
Drug 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.

Drug intervention groupTelephone intervention group

Include all the above interventions

Consulting+Telephone+Drug intervention

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

hospital-based population

You may qualify if:

  • current smoker aged 18 years or above, Chinese,
  • agreed to participate in the follow-up and signed an informed consent form.

You may not qualify if:

  • cognitively impaired and with severe diseases,
  • occasional or daily smoker,
  • Disagree and non-signed an informed consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Smoking Cessation

Interventions

Referral and ConsultationTobacco Use Cessation DevicesBupropionVarenicline

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services AdministrationTherapeuticsPropiophenonesKetonesOrganic ChemicalsBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinoxalines

Study Officials

  • Yao He, MD, PhD

    Institute of Geriatrics, Chinese PLA General Hospital, Beijing, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Institute of Geriatrics

Study Record Dates

First Submitted

August 25, 2013

First Posted

September 5, 2013

Study Start

October 1, 2008

Primary Completion

September 1, 2013

Study Completion

December 1, 2018

Last Updated

September 5, 2013

Record last verified: 2013-09