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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.

Trials
January 1, 1970
Myo Nyein Aung et al. (17 authors)
Comparative StudyJournal ArticleRandomized Controlled TrialResearch Support, Non-U.S. Gov'tHuman StudyClinical
Study Details

Study Goal

The researchers aimed to compare the effectiveness of a new smoking cessation service package, including nicotine replacement chewing gum, against traditional methods in diabetic and/or hypertensive smokers at risk of CVD.

Results Summary

The study evaluated a multicomponent intervention, including nicotine replacement chewing gum, but specific results regarding chewing gum's efficacy were not detailed in the abstract. The primary outcome was smoking cessation rates at 1-year follow-up.

Population

440 current smokers at CVD risk (diabetic and/or hypertensive) in Thailand.

Effective Dosage

Not specified

Duration

3 months for active intervention, 1-year follow-up

Interactions

None mentioned

Extracted Claims (9)
InterventionDirectionEndpointPopulationDosageImpactClaim #
newly devised evidence-based smoking cessation service package
neutral
smoking cessation rate
current smokers at CVD risk because of being diabetic and/or hypertensive
-
will be compared
#1
new smoking-cessation service-package
neutral
-
-
-
comprises
#2
regular patient motivation and coaching from the same primary care nurse over a 3-month period
neutral
-
-
-
-
#3
monthly application of piCO + smokerlyzer to sustain motivation of smoker's quitting attempt and provide positive feedback over a 3-month period
neutral
-
-
-
-
#4
assistance by an assigned family member
neutral
-
-
-
-
#5
nicotine replacement chewing gum
decrease
withdrawal symptoms
-
-
to relieve
#6
new service
neutral
-
-
-
will be compared
#7
traditional routine service comprising the 5A approach
neutral
-
-
-
-
#8
multicomponent intervention, accessible at primary healthcare clinics, and focusing on the individual as well as the family and social environment
neutral
-
-
-
is unique and expected to work effectively
#9
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. METHOD/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: Current Controlled Trials ISRCTN89315117.

Medical Subject Headings (MeSH)
AdultAgedAged, 80 and overCardiovascular DiseasesClinical ProtocolsCost-Benefit AnalysisEvidence-Based PracticeFemaleHumansMaleMiddle AgedOutcome Assessment, Health CareSample SizeSmoking Cessation
Study Links
Quality Scores
SafetyNot Assessed
Efficacy75/10
Quality85/10
Citation Metrics
Total Citations4
Citations/Year0.3
Relative Citation Ratio0.20
NIH Percentile10.1%
Research Impact Scores
APT Score0.25
Weight Score1.61
Normalized Score0.67
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