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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT01935505
Other study ID # IGPLAGH301YaoHe
Secondary ID
Status Enrolling by invitation
Phase N/A
First received August 25, 2013
Last updated September 4, 2013
Start date October 2008
Est. completion date December 2018

Study information

Verified date September 2013
Source Chinese PLA General Hospital
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 2000
Est. completion date December 2018
Est. primary completion date September 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- current smoker aged 18 years or above, Chinese,

- agreed to participate in the follow-up and signed an informed consent form.

Exclusion Criteria:

- cognitively impaired and with severe diseases,

- occasional or daily smoker,

- Disagree and non-signed an informed consent form.

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Behavioral:
Consulting
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.
Drug:
Nicotine patch
According to the smokers' level of nicotine dependency, disease history, cigarette consumption, prescription of drugs were provided, Nicotine Replacement Therapy, bupropion and varenicline.
Behavioral:
Telephone intervention
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 intervention
Include all the above interventions

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Chinese PLA General Hospital

Outcome

Type Measure Description Time frame Safety issue
Other changes of Knowledge Attitude and Practice up to 10 years No
Primary 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 No
Secondary decrease of tobacco consumption up to 10 years No
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