Study on the Model of Smoking Cessation Intervention and Service Ability Improvement

Smoking Cessation Clinical Trial

Official title:

Study on the Model of Smoking Cessation Intervention and Service Ability Improvement in General Hospital

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01935505
• Other study ID #: IGPLAGH301YaoHe
• 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

• Smoking Cessation

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