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

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.

Study Overview

• Status: Unknown
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: Consulting; Drug: Nicotine patch; Behavioral: Telephone intervention; Behavioral: Consulting+Telephone+Drug intervention

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 Type: Observational
• Enrollment (Anticipated): 2000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

hospital-based population

Description

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 Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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 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: 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.; Other Names: varenicline; Nicotine Replacement Therapy: Nicotine patch; bupropion; 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.
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: 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.; 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; All the interventions above are include in this group	Behavioral: Consulting+Telephone+Drug intervention; Include all the above interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
decrease of tobacco consumption	up to 10 years

Other Outcome Measures

Outcome Measure	Time Frame
changes of Knowledge Attitude and Practice	up to 10 years

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Investigators: Principal Investigator: Yao He, MD, PhD, Institute of Geriatrics, Chinese PLA General Hospital, Beijing, China

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Anticipated): September 1, 2013
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: August 25, 2013
• First Submitted That Met QC Criteria: September 4, 2013
• First Posted (Estimate): September 5, 2013

Study Record Updates

• Last Update Posted (Estimate): September 5, 2013
• Last Update Submitted That Met QC Criteria: September 4, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Chinese; smoking cessation; intervention model; quitting rate
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Cytochrome P-450 Enzyme Inhibitors; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Dopamine Uptake Inhibitors; Nicotine; Bupropion; Varenicline
• Other Study ID Numbers: IGPLAGH301YaoHe