title: Evidence-based new service package vs. routine service package for smoking cessation to prevent high risk patients from cardiovascular diseases (CVD): study protocol for randomized controlled trial.
abstract: BACKGROUND
  Smoking cessation is a high-priority intervention to prevent CVD events and deaths in developing countries. While several interventions to stop smoking have been proved successful, the question of how to increase their effectiveness and practicality in developing countries remains. In this study, a newly devised evidence-based smoking cessation service package will be compared with the existing service in a randomized controlled trial within the community setting of Thailand.
  
  
  METHODS
  This randomized control trial will recruit 440 current smokers at CVD risk because of being diabetic and/or hypertensive. Informed, consented participants will be randomly allocated into the new service-package arm and the routine service arm. The study will take place in the non-communicable disease clinics of the Maetha District Hospital, Lampang, northern Thailand. The new smoking-cessation service-package comprises (1) regular patient motivation and coaching from the same primary care nurse over a 3-month period; (2) monthly application of piCO + smokerlyzer to sustain motivation of smoker's quitting attempt and provide positive feedback over a 3-month period; (3) assistance by an assigned family member; (4) nicotine replacement chewing gum to relieve withdrawal symptoms. This new service will be compared with the traditional routine service comprising the 5A approach in a 1-year follow-up. Participants who consent to participate in the study but refuse to attempt quitting smoking will be allocated to the non-randomized arm, where they will be just followed up and monitored. Primary outcome of the study is smoking cessation rate at 1-year follow-up proven by breath analysis measuring carbomonoxide in parts per million in expired air. Secondary outcomes are smoking cessation rate at the 6-month follow-up, blood pressure and heart rate, CVD risk according to the Framingham general cardiovascular risk score, CVD events and deaths at the 12-month follow-up, and the cost-effectiveness of the health service packages. Intention-to-treat analysis will be followed. Factors influencing smoking cessation will be analyzed by the structure equation model.
  
  
  CONCLUSIONS
  This multicomponent intervention, accessible at primary healthcare clinics, and focusing on the individual as well as the family and social environment, is unique and expected to work effectively.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN89315117.
authors.affiliation: Department of Public Health, Juntendo University School of Medicine, Hongo 2-1-1, Bunkyo-ku, Tokyo 113-8421, Japan. myo@juntendo.ac.jp.
authors.forename: Myo Nyein
authors.initials: MN
authors.lastname: Aung
authors.forename: Motoyuki
authors.initials: M
authors.lastname: Yuasa
authors.forename: Thaworn
authors.initials: T
authors.lastname: Lorga
authors.forename: Saiyud
authors.initials: S
authors.lastname: Moolphate
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Fukuda
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Kitajima
authors.forename: Hirohide
authors.initials: H
authors.lastname: Yokokawa
authors.forename: Kazuo
authors.initials: K
authors.lastname: Minematsu
authors.forename: Susumu
authors.initials: S
authors.lastname: Tanimura
authors.forename: Yoshimune
authors.initials: Y
authors.lastname: Hiratsuka
authors.forename: Koichi
authors.initials: K
authors.lastname: Ono
authors.forename: Prissana
authors.initials: P
authors.lastname: Naunboonruang
authors.forename: Payom
authors.initials: P
authors.lastname: Thinuan
authors.forename: Sachio
authors.initials: S
authors.lastname: Kawai
authors.forename: Yaoyanee
authors.initials: Y
authors.lastname: Suya
authors.forename: Somboon
authors.initials: S
authors.lastname: Chumvicharana
authors.forename: Eiji
authors.initials: E
authors.lastname: Marui
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002318:Cardiovascular Diseases / Q000517:prevention & control*; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D055317:Evidence-Based Practice; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D018401:Sample Size; D016540:Smoking Cessation / Q000379:methods*